Clinical Orthopaedics and Related Research

Editorial: Is Open Access for You? It Depends Who “You” Are

01-02-2020 – Leopold, Seth S.

Journal Article

No abstract available

Editor’s Spotlight/Take 5: Has Prescription-limiting Legislation in Rhode Island Helped to Reduce Opioid Use After Total Joint Arthroplasty?

01-02-2020 – Manner, Paul A.

Journal Article

No abstract available

Has a Prescription-limiting Law in Rhode Island Helped to Reduce Opioid Use After Total Joint Arthroplasty?

01-02-2020 – Reid, Daniel B.C.; Shapiro, Benjamin; Shah, Kalpit N.; Ruddell, Jack H.; Cohen, Eric M.; Akelman, Edward; Daniels, Alan H.

Journal Article

Background In the United States, since 2016, at least 28 of 50 state legislatures have passed laws regarding mandatory prescribing limits for opioid medications. One of the earliest state laws (which was passed in Rhode Island in 2016) restricted the maximum morphine milligram equivalents provided in the first postoperative prescription for patients defined as opioid-naïve to 30 morphine milligram equivalents per day, 150 total morphine milligram equivalents, or 20 total doses. While such regulations are increasingly common in the United States, their effects on opioid use after total joint arthroplasty are unclear.
Questions/purposes (1) Are legislative limitations to opioid prescriptions in Rhode Island associated with decreased opioid use in the immediate (first outpatient prescription postoperatively), 30-day, and 90-day periods after THA and TKA? (2) Is this law associated with similar changes in postoperative opioid use among patients who are opioid-naïve and those who are opioid-tolerant preoperatively?Methods Patients undergoing primary THA or TKA between January 1, 2016 and June 28, 2016 (before the law was passed on June 28, 2016) were retrospectively compared with patients undergoing surgery between June 1, 2017 and December 31, 2017 (after the law’s implementation on April 17, 2017). The lapse between the pre-law and post-law periods was designed to avoid confounding from potential voluntary practice changes by physicians after the law was passed but before its mandatory implementation. Demographic and surgical details were extracted from a large multi-specialty orthopaedic group’s surgical billing database using Current Procedural Terminology codes 27130 and 27447. Any patients undergoing revision procedures, same-day bilateral arthroplasties, or a second primary THA or TKA in the 3-month followup period were excluded. Secondary data were confirmed by reviewing individual electronic medical records in the associated hospital system which included three major hospital sites. We evaluated 1125 patients. In accordance with the state’s department of health guidelines, patients were defined as opioid-tolerant if they had filled any prescription for an opioid medication in the 30-day preoperative period. Data on age, gender, and the proportion of patients who were defined as opioid tolerant preoperatively were collected and found to be no different between the pre-law and post-law groups. The state’s prescription drug monitoring program database was used to collect data on prescriptions for all controlled substances filled between 30 days preoperatively and 90 days postoperatively. The primary outcomes were the mean morphine milligram equivalents of the initial outpatient postoperative opioid prescription after discharge and the mean cumulative morphine milligram equivalents at the 30- and 90-day postoperative intervals. Secondary analyses included subgroup analyses by procedure and by preoperative opioid tolerance.
Results After the law was implemented, the first opioid prescriptions were smaller for patients who were opioid-naïve (mean 156 ± 106 morphine milligram equivalents after the law’s passage versus 451 ± 296 before, mean difference 294 morphine milligram equivalents; p < 0.001) and those who were opioid-tolerant (263 ± 265 morphine milligram equivalents after the law’s passage versus 534 ± 427 before, mean difference 271 morphine milligram equivalents; p < 0.001); however, for cumulative prescriptions in the first 30 days postoperatively, this was only true among patients who were previously opioid-naïve (501 ± 416 morphine milligram equivalents after the law’s passage versus 796 ± 597 before, mean difference 295 morphine milligram equivalents; p < 0.001). Those who were opioid-tolerant did not have a decrease in the cumulative number of 30-day morphine milligram equivalents (1288 ± 1632 morphine milligram equivalents after the law’s passage versus 1398 ± 1274 before, mean difference 110 morphine milligram equivalents; p = 0.066).
Conclusions The prescription-limiting law was associated with a decline in cumulative opioid prescriptions at 30 days postoperatively filled by patients who were opioid-naïve before total joint arthroplasty. This may substantially impact public health, and these policies should be considered an important tool for healthcare providers, communities, and policymakers who wish to combat the current opioid epidemic. However, given the lack of a discernible effect on cumulative opioids filled from 30 to 90 days postoperatively, further investigations are needed to evaluate more effective policies to prevent prolonged opioid use after total joint arthroplasty, particularly in patients who are opioid-tolerant preoperatively.
Level of Evidence Level III, therapeutic study.

Not the Last Word: Medicare for All is Not Enough

01-02-2020 – Bernstein, Joseph

Journal Article

No abstract available

Value-based Healthcare: Surgeon-specific Public Reporting in Total Joint Arthroplasty—A Rational Way Forward

01-02-2020 – Schwartz, Adam J.; Bozic, Kevin J.

Journal Article

No abstract available

Virtue Ethics in a Value-Driven World: What Do We Owe Other People’s Patients?

01-02-2020 – Humbyrd, Casey Jo

Journal Article

No abstract available

CORR® Curriculum—Orthopaedic Education: Teaching the Intricacies of the Surgeon-Industry Relationship

01-02-2020 – Dougherty, Paul J.

No abstract available

CORR® International—Asia-Pacific: How to Resolve Conflicts with Patients and Prevent Workplace Violence

01-02-2020 – Kim, Tae Kyun

No abstract available

Preoperative Activities of Daily Living Dependency is Associated With Higher 30-Day Readmission Risk for Older Adults After Total Joint Arthroplasty

01-02-2020 – Falvey, Jason R.; Bade, Michael J.; Hogan, Craig; Forster, Jeri E.; Stevens-Lapsley, Jennifer E.

Journal Article

Background With recent Medicare payment changes, older adults are increasingly likely to be discharged home instead of to extended care facilities after total joint arthroplasty (TJA), and may therefore be at increased risk for readmissions. Identifying risk factors for readmission could help re-align care pathways for vulnerable patients; recent research has suggested preoperative dependency in activities of daily living (ADL) may increase perioperative and postoperative surgical complications. However, the proportion of older surgical patients with ADL dependence before TJA, and the impact of ADL dependency on the frequency and timing of hospital readmissions is unknown.
Questions/purposes (1) What proportion of older adults discharged home after TJA have preoperative ADL dependency? (2) Is preoperative ADL dependency associated with increased risk of hospital readmissions at 30 days or 90 days for older adults discharged home after TJA?Methods This was a retrospective cohort analysis of 6270 Medicare fee-for-service claims from 2012 from a 5% national Medicare sample for older adults (older than 65 years) receiving home health care after being discharged to the community after elective TJA. Medicare home health claims were used for two reasons: (1) the primary population of interest was older adults and (2) the accompanying patient-level assessment data included an assessment of prior dependency on four ADL tasks. Activities of daily living dependency was dichotomized as severe (requiring human assistance with all four assessed tasks) or partial/none (needing assistance with three or fewer ADLs); this cutoff has been used in prior research to evaluate readmission risk. Multivariable logistic regression models, clustered at the hospital level and adjusted for known readmission risk factors (such as comorbidity status or age), were used to model the odds of 30- and 90- day and readmission for patients with severe ADL dependence.
Results Overall, 411 patients were hospitalized during the study period. Of all readmissions, 64% (262 of 411) occurred within the first 30 days, with a median (interquartile range IQR) time to readmission of 17 days (5 to 46). Severe ADL dependency before surgery was common for older home health recipients recovering from TJA, affecting 17% (1066 of 6270) of our sample population. After adjusting for clinical covariates, severe ADL dependency was not associated with readmissions at 90 days (adjusted odds ratio = 1.20 95% CI 0.93 to 1.55; p = 0.15). However, severe preoperative ADL dependency was associated with higher odds of readmission at 30 days (adjusted OR = 1.45 95% CI 1.11 to 1.99; p = 0.008).
Conclusions Severe preoperative ADL dependency is modestly associated with early but not late hospital readmission after TJA. This work demonstrates that it may important to apply a simple screening of ADL dependency preoperatively so that surgeons can guide changes in care planning for older adults undergoing TJA, which may include participation in preoperative rehabilitation (pre-habilitation) or more aggressive follow-up in the 30 days after surgery. Further research is needed to determine whether severe ADL dependence can be modified before surgery, and whether these changes in dependency can reduce readmission risk after TJA.
Level of Evidence Level III, therapeutic study.

CORR Insights®: Preoperative Activities of Daily Living Dependency Is Associated With Higher 30-Day Readmission Risk for Older Adults After Total Joint Arthroplasty

01-02-2020 – Webb, Matthew L.

Journal Article

No abstract available

How Accurate Are the Surgical Risk Preoperative Assessment System (SURPAS) Universal Calculators in Total Joint Arthroplasty?

01-02-2020 – Trickey, Amber W.; Ding, Qian; Harris, Alex H. S.

Journal Article

Background Surgical outcome prediction models are useful for many purposes, including informed consent, shared decision making, preoperative mitigation of modifiable risk, and risk-adjusted quality measures. The recently reported Surgical Risk Preoperative Assessment System (SURPAS) universal risk calculators were developed using 2005-2012 American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP), and they demonstrated excellent overall and specialty-specific performance. However, surgeons must assess whether universal calculators are accurate for the small subset of procedures they perform. To our knowledge, SURPAS has not been tested in a subset of patients undergoing lower-extremity total joint arthroplasty (TJA).
Questions/purposes How accurate are SURPAS models’ predictions for patients undergoing TJA?Methods We identified an internal subset of patients undergoing non-emergency THA or TKA from the 2012 ACS-NSQIP, the most recent year of the SURPAS development dataset. To assess the accuracy of SURPAS prediction models, 30-day postoperative outcomes were defined as in the original SURPAS study: mortality, overall morbidity, and six complication clusters—pulmonary, infectious, cardiac or transfusion, renal, venous thromboembolic, and neurologic. We calculated predicted outcome probabilities by applying coefficients from the published SURPAS logistic regression models to the TJA cohort. Discrimination was assessed with C-indexes, and calibration was assessed with Hosmer-Lemeshow 10-group chi-square tests and decile plots.
Results The 30-day postoperative mortality rate for TJA was 0.1%, substantially lower than the 1% mortality rate in the SURPAS development dataset. The most common postoperative complications for TJA were intraoperative or postoperative transfusion (16%), urinary tract infection (5%), and vein thrombosis (3%). The C-indexes for joint arthroplasty ranged from 0.56 for venous thromboembolism (95% CI 0.53 to 0.59 versus SURPAS C-index 0.78) to 0.82 for mortality (95% CI 0.76 to 0.88 versus SURPAS C-index 0.94). All joint arthroplasty C-index estimates, including CIs, were lower than those reported in the original SURPAS development study. Decile plots and Hosmer-Lemeshow tests indicated poor calibration. Observed mortality rates were lower than expected for patients in all risk deciles (lowest decile: no observed deaths, 0.0% versus expected 0.1%; highest decile: observed mortality 0.7% versus expected 2%; p < 0.001). Conversely, observed morbidity rates were higher than expected across all risk deciles (lowest decile: observed 12% versus expected 8%; highest decile: observed morbidity 32% versus expected 25%; p < 0.001)Conclusions The universal SURPAS risk models have lower accuracy for TJA procedures than they do for the wider range of procedures in which the SURPAS models were originally developed.
Clinical Relevance These results suggest that SURPAS model estimates must be evaluated for individual surgical procedures or within restricted groups of related procedures such as joint arthroplasty. Given substantial variation in patient populations and outcomes across numerous surgical procedures, universal perioperative risk calculators may not produce accurate and reliable results for specific procedures. Surgeons and healthcare administrators should use risk calculators developed and validated for specific procedures most relevant to each decision. Continued work is needed to assess the accuracy of universal risk calculators in more narrow procedural categories based on similarity of outcome event rates and prevalence of predictive variables across procedures.

CORR Insights®: How Accurate Are the Surgical Risk Preoperative Assessment System (SURPAS) Universal Calculators in Total Joint Arthroplasty?

01-02-2020 – Inacio, Maria C.

Journal Article

No abstract available

Are TKA Kinematics During Closed Kinetic Chain Exercises Associated with Patient-reported Outcomes? A Preliminary Analysis

01-02-2020 – Van Onsem, Stefaan; Verstraete, Matthias; Van Eenoo, Wies; Van Der Straeten, Catherine; Victor, Jan

Journal Article

Background Kinematic patterns after TKA can vary considerably from those of the native knee. It is unknown, however, if there is a relationship between a given kinematic pattern and patient satisfaction after TKA.
Questions/purposes Is there an association between kinematic patterns as measured by AP translation during open kinetic chain flexion-extension and closed kinetic chain exercises (rising from a chair and squatting) and a custom aggregate of patient-reported outcome measures (PROMs) that targeted symptoms, pain, activities of daily living (ADL), sports, quality of life (QOL), and patient satisfaction after TKA?Methods Thirty patients who underwent TKA between 2014 and 2016 were tested at a minimum follow-up of 6 months. As three different implants were used, per implant the first 10 patients who presented themselves at the follow-up consultations and were able to bend the knee at least 90°, were recruited. Tibiofemoral kinematics during an open kinetic chain flexion-extension and closed kinetic chain exercises—rising from a chair and squatting—were analyzed using fluoroscopy. A two-step cluster analysis was performed, resulting in two clusters of patients who answered the Knee Injury and Osteoarthritis Outcome Score and the satisfaction subscore of the Knee Society Score questionnaires. Cluster 1 (CL1) consisted of patients with better (good-to-excellent) patient-reported outcome measures scores (high-PROMs cluster); Cluster 2 (CL2) consisted of patients with poorer scores (low-PROMs cluster). Tibiofemoral kinematics were compared between patients in these clusters by performing a Mann-Whitney U test with Bonferroni correction.
Results Concerning open kinetic chain flexion-extension, there was no difference in kinematic patterns between the patients in the high-PROMs cluster and those in the low-PROMs cluster, with the numbers available. However, during the closed-chain kinetic exercises, medially, initial anterior translation (femur relative to tibia) was found in patients in Cluster 1 during early flexion, but in those in Cluster 2, translation was steeper and ran more anteriorly (CL1 -1.5 ± 7.3%; CL2 -8.5 ± 4.4%); mean difference 7.0% 95% CI 0.1 to 13.8; p = 0.046). In midflexion, the femur did not translate anterior nor posterior in relation to the tibia, resulting in a stable medial compartment in Cluster 1, whereas Cluster 2 had already started translating posteriorly (CL1 -0.7 ± 3.5%; CL2 3.4 ± 3.6%; mean difference -4.1% 95% CI -7.0 to -1.2; p = 0.008). There was no difference, with the numbers available, between the two clusters with respect to posterior translation in deep flexion. Laterally, there was small initial anterior translation in early flexion, followed by posterior translation in midflexion that continued in deep flexion. Patients in Cluster 1 demonstrated more pronounced posterior translation in deep flexion laterally than patients in Cluster 2 did (CL1 8.3 ± 5.2%; CL2 3.5 ± 4.5%); mean difference 4.9% 95% CI 0.6 to 9.1; p = 0.026).
Conclusions This study of total knee kinematics suggests that during closed kinetic chain movements, patients with poor PROM scores after TKA experience more anterior translation on the medial side followed by a medial mid-flexion instability and less posterior translation on the lateral side in deep flexion than patients with good PROM scores. The relationship of kinematic variations with patient-reported outcomes including satisfaction must be further elaborated and translated into TKA design and position. Reproduction of optimal kinematic patterns during TKA could be instrumental in improving patient satisfaction after total knee replacement. Future expansion of the study group is needed to confirm these findings.
Level of Evidence Level II, therapeutic study.

CORR Insights®: Are TKA Kinematics During Closed Kinetic Chain Exercises Associated with Patient-reported Outcomes? A Preliminary Analysis

01-02-2020 – D’Lima, Darryl D.

Journal Article

No abstract available

Does Robotic-assisted TKA Result in Better Outcome Scores or Long-Term Survivorship Than Conventional TKA? A Randomized, Controlled Trial

01-02-2020 – Kim, Young-Hoo; Yoon, Sung-Hwan; Park, Jang-Won

Journal Article

Background Robotic-assisted TKA was introduced to enhance the precision of bone preparation and component alignment with the goal of improving the clinical results and survivorship of TKA. Although numerous reports suggest that bone preparation and knee component alignment may be improved using robotic assistance, no long-term randomized trials of robotic-assisted TKA have shown whether this results in improved clinical function or survivorship of the TKA.
Questions/purposes In this randomized trial, we compared robotic-assisted TKA to manual-alignment techniques at long-term follow-up in terms of (1) functional results based on Knee Society, WOMAC, and UCLA Activity scores; (2) numerous radiographic parameters, including component and limb alignment; (3) Kaplan-Meier survivorship; and (4) complications specific to robotic-assistance, including pin-tract infection, peroneal nerve palsy, pin-site fracture, or patellar complications.
Methods This study was a registered prospective, randomized, controlled trial. From January 2002 to February 2008, one surgeon performed 975 robotic-assisted TKAs in 850 patients and 990 conventional TKAs in 849 patients. Among these patients 1406 patients were eligible for participation in this study based on prespecified inclusion criteria. Of those, 100% (1406) patients agreed to participate and were randomized, with 700 patients (750 knees) receiving robotic-assisted TKA and 706 patients (766 knees) receiving conventional TKA. Of those, 96% (674 patients) in the robotic-assisted TKA group and 95% (674 patients) in the conventional TKA group were available for follow-up at a mean of 13 (± 5) years. In both groups, no patient older than 65 years was randomized because we anticipated long-term follow-up. We evaluated 674 patients (724 knees) in each group for clinical and radiographic outcomes, and we examined Kaplan-Meier survivorship for the endpoint of aseptic loosening or revision. Clinical evaluation was performed using the original Knee Society knee score, the WOMAC score, and the UCLA activity score preoperatively and at latest follow-up visit. We also assessed loosening (defined as change in the position of the components) using plain radiographs, osteolysis using CT scans at the latest follow-up visit, and component, and limb alignment on mechanical axis radiographs.
To minimize the chance of type-2 error and increase the power of our study, we assumed the difference in the Knee Society score to be 5 points to match the MCID of the Knee Society with power of 0.99, which revealed that a total of 628 patients would be needed in each group.
Results Clinical parameters at the latest follow-up including the Knee Society knee scores (93 ± 5 points in the robotic-assisted TKA group versus 92 ± 6 points in the conventional TKA group 95% confidence interval 90 to 98; p = 0.321) and Knee Society knee function scores (83 ± 7 points in the robotic-assisted TKA group versus 85 ± 6 points in the conventional TKA group 95% CI 75 to 88; p = 0.992), WOMAC scores (18 ± 14 points in the robotic-assisted TKA group versus 19 ± 15 points in the conventional TKA group 95% CI 16 to 22; p = 0.981), range of knee motion (125 ± 6° in the robotic-assisted TKA group versus 128 ± 7° in the conventional TKA group 95% CI 121 to 135; p = 0.321), and UCLA patient activity scores (7 points versus 7 points in each group 95% CI 5 to 10; p = 1.000) were not different between the two groups at a mean of 13 years’ follow-up. Radiographic parameters such as the femorotibial angle (mean 2° ± 2° valgus in the robotic-assisted TKA group versus 3° ± 3° valgus in the conventional TKA group 95% CI 1 to 5; p = 0.897), femoral component position (coronal plane: mean 98° in the robotic-assisted TKA group versus 97° in the conventional TKA group 95% CI 96 to 99; p = 0.953; sagittal plane: mean 3° in the robotic-assisted TKA group versus 2° in the conventional TKA group 95% CI 1 to 4; p = 0.612) and tibial component position (coronal plane: mean 90° in the robotic-assisted TKA group versus 89° in the conventional TKA group 95% CI 87 to 92; p = 0.721; sagittal plane: 87° in the robotic-assisted TKA group versus 86° in the conventional TKA group 95% CI 84 to 89; p = 0.792), joint line (16 mm in the robotic-assisted TKA group versus 16 mm in the conventional TKA group 95% CI 14 to 18; p = 0.512), and posterior femoral condylar offset (24 mm in the robotic-assisted TKA group versus 24 mm in the conventional TKA group 95% CI 21 to 27 ; p = 0.817) also were not different between the two groups (p > 0.05). The aseptic loosening rate was 2% in each group, and this was not different between the two groups. With the endpoint of revision or aseptic loosening of the components, Kaplan-Meier survivorship of the TKA components was 98% in both groups (95% CI 94 to 100) at 15 years (p = 0.972). There were no between-group differences in terms of the frequency with which complications occurred. In each group, 2% of knees (15) had a superficial infection treated with intravenous antibiotics for 2 weeks. No deep infection occurred in these knees. In the conventional TKA group, 0.8% of knees (six) had a motion limitation (< 60°).
Conclusions At a minimum follow-up of 10 years, we found no differences between robotic-assisted TKA and conventional TKA in terms of functional outcome scores, aseptic loosening, overall survivorship, and complications. Considering the additional time and expense associated with robotic-assisted TKA, we cannot recommend its widespread use.
Level of Evidence Level I, therapeutic study.

CORR Insights®: Does Robotic-assisted TKA Result in Better Outcome Scores or Long-Term Survivorship Than Conventional TKA? A Randomized, Controlled Trial

01-02-2020 – Dorr, Lawrence D.

Journal Article

No abstract available

Is Isolated Mobile Component Exchange an Option in the Management of Intraprosthetic Dislocation of a Dual Mobility Cup?

01-02-2020 – Wegrzyn, Julien; Malatray, Matthieu; Pibarot, Vincent; Anania, Gaetano; Béjui-Hugues, Jacques

Journal Article

Background Intraprosthetic dislocation is a specific complication of dual mobility cups, although it occurs less frequently with the latest generations of implants. Intraprosthetic dislocation is related to long-term polyethylene wear of the mobile component chamfer and retentive area, leading to a snap-out of the femoral head. With the increased use of dual mobility cups, even in younger and active patients, the management of intraprosthetic dislocation should be defined according to its type. However, no previous studies, except for case reports, have described the strategy to manage long-term wear-related intraprosthetic dislocation, particularly when a dual mobility cup is not loose.
Questions/purposes This study aimed to (1) determine the prevalence of intraprosthetic dislocation in this patient population and the macroscopic findings at the time of surgical revision and (2) evaluate whether isolated mobile component exchange could be an option to manage intraprosthetic dislocation occurring with a well-fixed dual mobility cup metal shell.
Methods From January 1991 to December 2009, a continuous series of 5274 THAs with dual mobility cups (4546 patients; 2773 women; mean range age 58 years 22-87; bilateral THA = 728) were prospectively enrolled in our institutional total joint registry. A cementless, hemispherical dual mobility cup was systematically implanted, regardless of the patient’s age or indication for THA. At the latest follow-up examination, the registry was queried to isolate each occurrence of intraprosthetic dislocation, which was retrospectively analyzed regarding the patient’s demographics, indication for THA, radiographs, intraoperative findings (polyethylene wear and lesion patterns on the mobile component, periarticular metallosis, and implant damage because of intraprosthetic impingement of the femoral neck), management of intraprosthetic dislocation (isolated exchange of the mobile component or revision of the dual mobility cup), and outcome.
Results At a mean (range) follow-up duration of 14 years (3-26), 3% of intraprosthetic dislocations (169 of 5274) were reported, with a mean (range) time from THA of 18 years (13-22). Intraprosthetic dislocation occurred predominantly in younger men (mean range age at THA, 42 years 22-64 versus 61 years 46-87; p < 0.001, and sex ratio (male to female, 1:32 96 male and 73 female versus 0.62 1677 male and 2700 female; p < 0.001) in patients with intraprosthetic dislocation and those without, respectively, but was not influenced by the indication for THA (105 patients with intraprosthetic dislocation who underwent THA for primary hip osteoarthritis and 64 with other diagnoses versus 3146 patients without who underwent THA for primary hip osteoarthritis and 1959 for other diagnoses (p = 0.9)). In all patients with intraprosthetic dislocation, a macroscopic analysis of the explanted mobile component revealed circumferential polyethylene wear and damage to the chamfer and retentive area, with subsequent loss of retaining power for the femoral head. Nine percent of intraprosthetic dislocations (16 of 169 patients with intraprosthetic dislocations) were associated with aseptic loosening of the dual mobility cup and were managed with acetabular revision without recurrence at a mean (range) follow-up duration of 7.5 years (5-11). Ninety-one percent of intraprosthetic dislocations (153 of 169) were pure, related to wear of the mobile component chamfer and retentive area without aseptic loosening of the dual mobility cup, and managed with isolated mobile component exchange. Intraprosthetic dislocation recurred in 6% (nine of 153) at a mean (range) follow-up interval of 3 years (2-4.5). Additionally, severe premature polyethylene wear of the mobile component with loosening of the dual mobility cup occurred in 12% of patients (19 of 153) at a mean (range) follow-up duration of 1.5 years (0.5-3).
Conclusions A failure rate of 18% (28 of 153 patients undergoing isolated mobile component exchange) was reported within 5 years after isolated mobile component exchange to manage intraprosthetic dislocation occurring with a well-fixed dual mobility cup metal shell. The two modes of failure were early recurrence of intraprosthetic dislocation or severe premature metallosis-related polyethylene wear of the mobile component with loosening of the dual mobility cup. Acetabular revision with synovectomy should remain the standard procedure to manage intraprosthetic dislocation, particularly if periarticular metallosis is present. The exception is intraprosthetic dislocation occurring in elderly or frail patients, for whom a conventional acetabular revision procedure would be associated with an unjustified surgical or anesthetic risk.
Level of Evidence Level II, prognostic study.

CORR Insights®: Is Isolated Mobile Component Exchange an Option in the Management of Intraprosthetic Dislocation of a Dual Mobility Cup?

01-02-2020 – Kurmis, Andrew P.

Journal Article

No abstract available

Which Factors Are Associated with Local Control and Survival of Patients with Localized Pelvic Ewing’s Sarcoma? A Retrospective Analysis of Data from the Euro-EWING99 Trial

01-02-2020 – Andreou, Dimosthenis; Ranft, Andreas; Gosheger, Georg; Timmermann, Beate; Ladenstein, Ruth; Hartmann, Wolfgang; Bauer, Sebastian; Baumhoer, Daniel; van den Berg, Henk; Dijkstra, P.D. Sander; Dürr, Hans Roland; Gelderblom, Hans; Hardes, Jendrik; Hjorth, Lars; Kreyer, Justus; Kruseova, Jarmila; Leithner, Andreas; Scobioala, Sergiu; Streitbürger, Arne; Tunn, Per-Ulf; Wardelmann, Eva; Windhager, Reinhard; Jürgens, Heribert; Dirksen, Uta; for the GPOH-Euro-EWING99 consortium

Journal Article

Background Local treatment of pelvic Ewing’s sarcoma may be challenging, and intergroup studies have focused on improving systemic treatments rather than prospectively evaluating aspects of local tumor control. The Euro-EWING99 trial provided a substantial number of patients with localized pelvic tumors treated with the same chemotherapy protocol. Because local control included surgical resection, radiation therapy, or a combination of both, we wanted to investigate local control and survival with respect to the local modality in this study cohort.
Questions/purposes (1) Do patients with localized sacral tumors have a lower risk of local recurrence and higher survival compared with patients with localized tumors of the innominate bones? (2) Is the local treatment modality associated with local control and survival in patients with sacral and nonsacral tumors? (3) Which local tumor- and treatment-related factors, such as response to neoadjuvant chemotherapy, institution where the biopsy was performed, and surgical complications, are associated with local recurrence and patient survival in nonsacral tumors? (4) Which factors, such as persistent extraosseous tumor growth after chemotherapy or extent of bony resection, are independently associated with overall survival in patients with bone tumors undergoing surgical treatment?Methods Between 1998 and 2009, 1411 patients with previously untreated, histologically confirmed Ewing’s sarcoma were registered in the German Society for Pediatric Oncology and Hematology Ewing’s sarcoma database and treated in the Euro-EWING99 trial. In all, 24% (339 of 1411) of these patients presented with a pelvic primary sarcoma, 47% (159 of 339) of which had macroscopic metastases at diagnosis and were excluded from this analysis. The data from the remaining 180 patients were reviewed retrospectively, based on follow-up data as of July 2016. The median (range) follow-up was 54 months (5 to 191) for all patients and 84 months (11 to 191) for surviving patients. The study endpoints were overall survival, local recurrence and event-free survival probability, which were calculated with the Kaplan-Meier method and compared using the log-rank test. Hazard ratios (HRs) with their respective 95% CIs were estimated in a multivariate Cox regression model.
Results Sacral tumors were associated with a reduced probability of local recurrence (12% 95% CI 1 to 22 versus 28% 95% CI 20 to 36 at 5 years, p = 0.032), a higher event-free survival probability (66% 95% CI 51 to 81 versus 50% 95% CI 41 to 58 at 5 years, p = 0.026) and a higher overall survival probability (72% 95% CI 57 to 87 versus 56% 95% CI 47 to 64 at 5 years, p = 0.025) compared with nonsacral tumors. With the numbers available, we found no differences between patients with sacral tumors who underwent definitive radiotherapy and those who underwent combined surgery and radiotherapy in terms of local recurrence (17% 95% CI 0 to 34 versus 0% 95% CI 0 to 20 at 5 years, p = 0.125) and overall survival probability (73% 95% CI 52 to 94 versus 78% 95% CI 56 to 99 at 5 years, p = 0.764). In nonsacral tumors, combined local treatment was associated with a lower local recurrence probability (14% 95% CI 5 to 23 versus 33% 95% CI 19 to 47 at 5 years, p = 0.015) and a higher overall survival probability (72% 95% CI 61 to 83 versus 47% 95% CI 33 to 62 at 5 years, p = 0.024) compared with surgery alone. Even in a subgroup of patients with wide surgical margins and a good histologic response to induction treatment, the combined local treatment was associated with a higher overall survival probability (87% 95% CI 74 to 100 versus 51% 95% CI 33 to 69 at 5 years, p = 0.009), compared with surgery alone.
A poor histologic response to induction chemotherapy in nonsacral tumors (39% 95% CI 19 to 59 versus 64% 95% CI 52 to 76 at 5 years, p = 0.014) and the development of surgical complications after tumor resection (35% 95% CI 11 to 59 versus 68% 95% CI 58 to 78 at 5 years, p = 0.004) were associated with a lower overall survival probability in nonsacral tumors, while a tumor biopsy performed at the same institution where the tumor resection was performed was associated with lower local recurrence probability (14% 95% CI 4 to 24 versus 32% 95% CI 16 to 48 at 5 years, p = 0.035), respectively.
In patients with bone tumors who underwent surgical treatment, we found that after controlling for tumor localization in the pelvis, tumor volume, and surgical margin status, patients who did not undergo complete (defined as a Type I/II resection for iliac bone tumors, a Type II/III resection for pubic bone and ischium tumors and a Type I/II/III resection for tumors involving the acetabulum, according to the Enneking classification) removal of the affected bone (HR 5.04 95% CI 2.07 to 12.24; p < 0.001), patients with a poor histologic response to induction chemotherapy (HR 3.72 95% CI 1.51 to 9.21; p = 0.004), and patients who did not receive additional radiotherapy (HR 4.34 95% CI 1.71 to 11.05; p = 0.002) had a higher risk of death. The analysis suggested that the same might be the case in patients with a persistent extraosseous tumor extension after induction chemotherapy (HR 4.61 95% CI 1.03 to 20.67; p = 0.046), although the wide CIs pointing at a possible sparse-data bias precluded any definitive conclusions.
Conclusion Patients with sacral Ewing’s sarcoma appear to have a lower probability for local recurrence and a higher overall survival probability compared with patients with tumors of the innominate bones. Our results seem to support a recent recommendation of the Scandinavian Sarcoma Group to locally treat most sacral Ewing’s sarcomas with definitive radiotherapy. Combined surgical resection and radiotherapy appear to be associated with a higher overall survival probability in nonsacral tumors compared with surgery alone, even in patients with a wide resection and a good histologic response to neoadjuvant chemotherapy. Complete removal of the involved bone, as defined above, in patients with nonsacral tumors may be associated with a decreased likelihood of local recurrence and improved overall survival. Persistent extraosseous tumor growth after induction treatment in patients with nonsacral bone tumors undergoing surgical treatment might be an important indicator of poorer overall survival probability, but the possibility of sparse-data bias in our cohort means that this factor should first be validated in future studies.
Level of Evidence Level III, therapeutic study.

CORR Insights®: Which Factors Are Associated with Local Control and Survival of Patients with Localized Pelvic Ewing’s Sarcoma? A Retrospective Analysis of Data from the Euro-EWING99 Trial

01-02-2020 – Gitelis, Steven

Journal Article

No abstract available

Thirty-day Postoperative Complications After Surgery For Metastatic Long Bone Disease Are Associated With Higher Mortality at 1 Year

01-02-2020 – Bindels, Bas J. J.; Thio, Quirina C. B. S.; Raskin, Kevin A.; Ferrone, Marco L.; Lozano Calderón, Santiago A.; Schwab, Joseph H.

Journal Article

Background The benefits of surgical treatment of a metastasis of the extremities may be offset by drawbacks such as potential postoperative complications. For this group of patients, the primary goal of surgery is to improve quality of life in a palliative setting. A better comprehension of factors associated with complications and the impact of postoperative complications on mortality may prevent negative outcomes and help surgeons in surgical decision-making.
Questions/purposes (1) What is the risk of 30-day postoperative complications after surgical treatment of osseous metastatic disease of the extremities? (2) What predisposing factors are associated with a higher risk of 30-day complications? (3) Are minor and major 30-day complications associated with higher mortality at 1 year?Methods Between 1999 and 2016, 1090 patients with osseous metastatic disease of the long bones treated surgically at our institution were retrospectively included in the study. Surgery included intramedullary nailing (58%), endoprosthetic reconstruction (22%), plate-screw fixation (14%), dynamic hip screw fixation (2%), and combined approaches (4%). Surgery was performed if patients were deemed healthy enough to proceed to surgery and wished to undergo surgery. All data were retrieved by manually reviewing patients’ records. The overall frequency of complications, which were defined using the Clavien-Dindo classification system, was calculated. We did not include Grade I complications as postoperative complications and complications were divided into minor (Grade II) and major (Grades III-V) complications. A multivariate logistic regression analysis was used to identify factors associated with 30-day postoperative complications. A Cox regression analysis was used to assess the association between postoperative complications and overall survival.
Results Overall, 31% of the patients (333 of 1090) had a postoperative complication within 30 days. The following factors were independently associated with 30-day postoperative complications: rapidly growing primary tumors classified according to the modified Katagiri classification (odds ratio 1.6; 95% confidence interval, 1.1-2.2; p = 0.011), multiple bone metastases (OR 1.6; 95% CI, 1.1-2.3; p = 0.008), pathologic fracture (OR 1.5; 95% CI, 1.1-2.0; p = 0.010), lower-extremity location (OR 2.2; 95% CI, 1.6-3.2; p < 0.001), hypoalbuminemia (OR 1.7; 95% CI, 1.2-2.4; p = 0.002), hyponatremia (OR 1.5; 95% CI, 1.0-2.2; p = 0.044), and elevated white blood cell count (OR 1.6; 95% CI, 1.1-2.4; p = 0.007). Minor and major postoperative complications within 30 days after surgery were both associated with greater 1-year mortality (hazard ratio 1.6; 95% CI, 1.3-1.8; p < 0.001 and HR 3.4; 95% CI, 2.8-4.2, respectively; p < 0.001).
Conclusion Patients with metastatic disease in the long bones are vulnerable to postoperative adverse events. When selecting patients for surgery, surgeons should carefully assess a patient’s cancer status, and several preoperative laboratory values should be part of the standard work-up before surgery. Furthermore, 30-day postoperative complications decrease survival within 1 year after surgery. Therefore, patients at a high risk of having postoperative complications are less likely to profit from surgery and should be considered for nonoperative treatment or be monitored closely after surgery.
Level of Evidence Level III, therapeutic study.

CORR Insights®: Thirty-day Postoperative Complications After Surgery for Metastatic Long Bone Disease Are Associated With Higher Mortality at 1 Year

01-02-2020 – Levin, Adam S.

Journal Article

No abstract available

Development and Internal Validation of Machine Learning Algorithms for Preoperative Survival Prediction of Extremity Metastatic Disease

01-02-2020 – Thio, Quirina C. B. S.; Karhade, Aditya V.; Ogink, Paul T.; Bramer, Jos A. M.; Ferrone, Marco L.; Calderón, Santiago Lozano; Raskin, Kevin A.; Schwab, Joseph H.

Journal Article

Background A preoperative estimation of survival is critical for deciding on the operative management of metastatic bone disease of the extremities. Several tools have been developed for this purpose, but there is room for improvement. Machine learning is an increasingly popular and flexible method of prediction model building based on a data set. It raises some skepticism, however, because of the complex structure of these models.
Questions/purposes The purposes of this study were (1) to develop machine learning algorithms for 90-day and 1-year survival in patients who received surgical treatment for a bone metastasis of the extremity, and (2) to use these algorithms to identify those clinical factors (demographic, treatment related, or surgical) that are most closely associated with survival after surgery in these patients.
Methods All 1090 patients who underwent surgical treatment for a long-bone metastasis at two institutions between 1999 and 2017 were included in this retrospective study. The median age of the patients in the cohort was 63 years (interquartile range IQR 54 to 72 years), 56% of patients (610 of 1090) were female, and the median BMI was 27 kg/m2 (IQR 23 to 30 kg/m2). The most affected location was the femur (70%), followed by the humerus (22%). The most common primary tumors were breast (24%) and lung (23%). Intramedullary nailing was the most commonly performed type of surgery (58%), followed by endoprosthetic reconstruction (22%), and plate screw fixation (14%). Missing data were imputed using the miss
Forest methods. Features were selected by random forest algorithms, and five different models were developed on the training set (80% of the data): stochastic gradient boosting, random forest, support vector machine, neural network, and penalized logistic regression. These models were chosen as a result of their classification capability in binary datasets. Model performance was assessed on both the training set and the validation set (20% of the data) by discrimination, calibration, and overall performance.
Results We found no differences among the five models for discrimination, with an area under the curve ranging from 0.86 to 0.87. All models were well calibrated, with intercepts ranging from -0.03 to 0.08 and slopes ranging from 1.03 to 1.12. Brier scores ranged from 0.13 to 0.14. The stochastic gradient boosting model was chosen to be deployed as freely available web-based application and explanations on both a global and an individual level were provided. For 90-day survival, the three most important factors associated with poorer survivorship were lower albumin level, higher neutrophil-to-lymphocyte ratio, and rapid growth primary tumor. For 1-year survival, the three most important factors associated with poorer survivorship were lower albumin level, rapid growth primary tumor, and lower hemoglobin level.
Conclusions Although the final models must be externally validated, the algorithms showed good performance on internal validation. The final models have been incorporated into a freely accessible web application that can be found at https://sorg-apps.shinyapps.io/extremitymetssurvival/. Pending external validation, clinicians may use this tool to predict survival for their individual patients to help in shared treatment decision making.
Level of Evidence Level III, therapeutic study.

Does Curve Regression Occur During Underarm Bracing in Patients with Adolescent Idiopathic Scoliosis?

01-02-2020 – Cheung, Jason Pui Yin; Cheung, Prudence Wing Hang; Yeng, Wing Cheung; Chan, Lawrence Chi Kwan

Journal Article

Background Successful brace treatment entails good control of scoliosis with avoidance of surgery. However, achieving curve regression may be an even better radiological result than prevention of curve progression for patients with adolescent idiopathic scoliosis. Vertebral remodeling may occur with well-fitted braces. Better in-brace curve correction may influence the likelihood of vertebral remodeling and the chance of curve regression. Only a few reports have evaluated curve regression with brace treatment, and the factors associated with these events are unknown.
Questions/purposes (1) What changes in curvature are observed with brace treatment for adolescent idiopathic scoliosis? (2) What factors are associated with curve improvement? (3) What factors are associated with curve deterioration? (4) Is curve regression associated with improvements in patient-reported objective outcome scores?Methods Between September 2008 and December 2013, 666 patients with adolescent idiopathic scoliosis underwent underarm brace treatment and were followed until skeletal maturity at 18 years old. Among these patients, 80 were excluded because of early discontinuation of brace treatment (n = 66) and loss to follow-up (n = 14). Hence, 586 patients were included in this study, with a mean brace-wear duration of 3.8 ± 1.5 years and post-weaning follow-up duration of 2.0 ± 1.1 years. The mean age at baseline was 12.6 ± 1.2 years. Most patients were female (87%, 507 of 586) and up to 53% (267 of 507) of females were post-menarche. Bracing outcomes were based on changes in the Cobb angle measured out of brace. These included curve regression, as indicated by at least a 5° reduction in the Cobb angle, curve progression, as indicated by at least a 5° increase in the Cobb angle, and unchanged, as indicated by a change in the Cobb angle of less than 5°. We studied the pre-brace and supine Cobb angles, curve flexibility (pre-brace Cobb angle – supine Cobb angle / pre-brace Cobb angle x 100%), correction rate (pre-brace Cobb angle – in-brace Cobb angle / pre-brace Cobb angle x 100%), location of apical vertebrae, apical ratio (convex vertebral height/concave vertebral height), change in the major curve Cobb angle, and apical ratio post-bracing. The refined 22-item Scoliosis Research Society questionnaire was used for patient-reported outcomes and is composed of five domains (function, pain, appearance, mental health and satisfaction with treatment). Its minimum clinically important difference, based on a scale from 0 to 5, has been quoted as 0.2 for pain, 0.08 for activity and 0.98 for appearance domains. Mental health has no quoted minimum clinically important difference for the adolescent idiopathic scoliosis population. Satisfaction with treatment is described based on improvement or deterioration in domain scores. Intergroup differences between bracing outcomes were evaluated with the Kruskal Wallis test. Univariate analyses of bracing outcomes were performed with a point-biserial correlation coefficient for continuous variables and Pearson’s chi-square test for categorical variables. Multivariate logistic regression models were created for improved and deteriorated outcomes. P values < 0.05 were considered significant.
Results In all, 17% of patients (98 of 586) had an improved angle and 40% of patients (234 of 586) had curve deterioration. In patients who improved, the mean reduction in the Cobb angle was 9 ± 4°, while in patients who deteriorated, the mean increase in the Cobb angle was 15 ± 9°, and this was maintained at the latest post-brace weaning follow-up. Despite a trend for patients with curve regression to have higher baseline flexibility and correction rate, after controlling for age, Risser staging, radius and ulnar grading, and Sanders staging, we found no clinically important differences with increased correction rate or flexibility. We did find that improvement in the Cobb angle after bracing was associated with reduced apical ratio (odds ratio OR 0.84 95% CI 0.80 to 0.87; p < 0.001). Curve progression was associated with younger age (OR 0.71 95% CI 0.55 to 0.91; p = 0.008), pre-menarche status (OR 2.46 95% CI 1.31 to 4.62; p = 0.005), and increased apical ratio (OR 1.24 95% CI 1.19 to 1.30; p < 0.001) but no clinically important differences were observed with less flexible curves and reduced correction rate. Improvements in scores of the refined 22-item Scoliosis Research Society domains of function (mean difference on a scale from 0 to 5: 0.2; p = 0.001 versus 0.1; p < 0.001) and pain (mean difference on a scale from 0 to 5: 0.2; p = 0.020 versus 0.0; p = 0.853) were greater in the post-brace improvement group than in the deterioration group and fulfilled the minimum clinically important difference threshold. The appearance domain did not fulfill the minimum clinically important difference. Satisfaction with treatment domain score minimally improved with the curve regression group (mean difference on a scale from 0 to 5: 0.2) but deteriorated in the curve progression group (mean difference on a scale from 0 to 5: -0.4).
Conclusions Curve regression occurs after underarm bracing and is associated with superior patient-reported outcome scores. This possible change in Cobb angle should be explained to patients before and during bracing. Whether this may help improve patients’ duration of brace-wear should be addressed in future studies. Patients with well-fitting braces may experience curve improvement and possible vertebral remodeling. Those braced at a younger age and with increased vertebral wedging are more likely to have curve progression.
Level of Evidence Level III, therapeutic study.

CORR Insights®: Does Curve Regression Occur During Underarm Bracing in Patients with Adolescent Idiopathic Scoliosis?

01-02-2020 – Armstrong, Douglas G.

Journal Article

No abstract available

Are There Differences Between Patients with Extreme Stenosis and Non-extreme Stenosis in Terms of Pain, Function or Complications After Spinal Decompression Using a Tubular Retractor System?

01-02-2020 – Kulkarni, Arvind G.; Das, Swaroop; Kunder, Tushar S.

Journal Article

Background Micro-tubular decompression in extreme lumbar spinal stenosis is challenging because it is technically difficult to achieve adequate decompression. Whether the results of micro-tubular decompression related to pain, function, and complications in lumbar spinal stenosis of the extreme and non-extreme varieties are different has not yet been conclusively established.
Questions/purposes Are there differences between patients with extreme stenosis and non-extreme stenosis in terms of (1) VAS back or leg pain, (2) Oswestry Disability Index (ODI), or (3) complications when they were treated with spinal decompression using a tubular retractor system?Methods Between January 2007 and January 2017, one surgeon performed 325 single-level lumbar micro-tubular decompressions without fusion. Of those, 43% (140 of 325) had extreme stenosis (defined as the absence of cerebrospinal fluid signal and a grey homogeneous dural sac with unrecognizable rootlets and posterior epidural fat in T2 weighted axial MRI image) and the rest had non-extreme stenosis. During this time, we used tubular retractors for these procedures in patients with simple lumbar spinal stenosis who had persistent symptoms despite conservative treatment for neurogenic claudication. No alternate form of decompression was performed in the study period. Patients with complex lumbar spinal stenosis associated with a deformity or instability who were treated with instrumented fusion were excluded. A total of 14% (20 of 140) patients in the extreme stenosis group and 15% (28 of 185) patients in the non-extreme stenosis group were lost to follow-up before 2 years; the remaining 120 patients with extreme stenosis and 157 patients with non-extreme stenosis were analyzed at a mean follow-up of 33 ± 5 months in this retrospective, comparative study. The groups were not different at baseline in terms of preoperative VAS score for back pain, age, gender, BMI or the percentage who had diabetes or who smoked. However, patients with extreme stenosis had higher preoperative ODI scores and higher preoperative VAS score for leg pain compared with the non-extreme group. There was a higher proportion of men in the non-extreme stenosis group (56% 104 of 185 versus 50% 71 of 140; p = 0.324). Study endpoints were VAS score for leg and back pain, ODI, and complications, all of which were ascertained by chart review. With the numbers available, we could detect with 80% power at p < 0.05 a difference of 0.93 cm of 10 cm on a 10-cm VAS scale for VAS leg pain; a difference of 1.00 cm of 10 cm on a 10-cm VAS scale for VAS back pain and a difference of 2.12 cm of 100 cm on a 100-cm ODI scale.
Results In terms of pain, both groups improved after surgery, but there was no between-group difference in terms of the VAS scores at the most recent follow-up. VAS back pain improved from a mean of 3 ± 1 to 2 ± 1 in the extreme stenosis group and from 3 ± 1 to 1 ± 1 in the non-extreme stenosis group (p = 0.904); VAS leg pain improved from 7 ± 1 to 1 ± 1 versus 6 ± 1 to 1 ± 1, respectively (p = 0.537). ODI scores likewise improved in both groups, with no between-group difference in the ODI scores at latest follow-up (66 ± 7 to 19 ± 2 in the extreme stenosis group versus 59 ± 5 to 19 ± 2 in the non-extreme stenosis group (p = 0.237). Complications in the group with extreme stenosis occurred in six patients (incidental dural tears in two patients, urinary retention in three patients, and Syndrome of Inappropriate Anti Diuretic Hormone secretion (SIADH) in one patient); complications in the non-extreme stenosis occurred in two patients (incidental dural tears in two patients).
Conclusions The results in terms of improvement in VAS for leg and back pain and ODI scores were not different between patients with extreme and non-extreme stenosis. Micro-tubular decompression can be thus considered an alternative for patients with extreme stenosis. Future studies, ideally multicentre, comparative trials, are needed to confirm our preliminary results.
Level of Evidence Level III, therapeutic study.

CORR Insights®: Are There Differences Between Patients with Extreme Stenosis and Non-extreme Stenosis in Terms of Pain, Function or Complications After Spinal Decompression Using a Tubular Retractor System?

01-02-2020 – Reitman, Charles A.

Journal Article

No abstract available

Do External Supports Improve Dynamic Balance in Patients with Chronic Ankle Instability? A Network Meta-analysis

01-02-2020 – Tsikopoulos, Konstantinos; Sidiropoulos, Konstantinos; Kitridis, Dimitrios; Cain ATC, Spencer M.; Metaxiotis, Dimitrios; Ali, Ashique

Journal Article

Background To improve ankle stability in patients who have experienced an ankle sprain with residual symptoms of instability and/or objective joint laxity, external supports (such as taping, bracing, and orthotic insoles) are used sometimes. However, available randomized trials have disagreed on whether restraints improve balance in those individuals. In this situation, a network meta-analysis can help because it allows for comparing multiple treatments simultaneously, taking advantage not only of direct but also indirect evidence synthesis.
Questions/purposes The aim of this network meta-analysis was to assess (1) the impact of taping and orthotic devices on dynamic postural control in individuals with ankle instability and (2) the presence of a placebo effect in participants treated with sham taping and complications resulting from the administered treatments.
Methods We searched the PubMed, Scopus, and CENTRAL databases up to February 13, 2019 for completed studies. Randomized trials assessing the results of real and/or sham taping, wait-and-see protocols, ankle bracing, and foot orthotics for ankle instability as determined by one or more ankle sprains followed by ongoing subjective symptoms and/or mechanical laxity were included. We evaluated dynamic postural control in terms of the Star Excursion Balance Test in the posteromedial direction (SEBT-PM), which is considered the most representative of balance deficits in patients with ankle instability. Standardized mean differences were re-expressed to percentage differences in SEBT-PM, with higher scores representing possible improvement. Subsequently, those data were checked against the established minimal detectable change of 14% for this scale to make judgements on clinical importance. We also assessed the presence of a placebo effect by comparing the results of sham taping with no treatment and complications resulting from the administered treatments. Additionally, we judged the quality of trials using the Cochrane risk of bias tool and quality of evidence using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach. A total of 22 trials met our inclusion criteria, 18 of which were deemed to be at a low risk of bias. A network of treatments consisting of 13 studies was created, and the level of evidence was judged to be high. As far as participants’ allocation to treatment arms, 85 patients followed a wait-and-see protocol, 29 received placebo taping, 99 were treated with taping, 16 were treated with bracing, 27 were administered insoles, and six individuals were offered a combination of insoles with bracing. Of note, with statistical power set at 80%, a minimum of 16 patients per treatment group was required to provide sufficient statistical power and detect a SEBT-PM percentage difference of 14%.
Results A network meta-analysis did not demonstrate a benefit of taping or bracing over no treatment (percentage difference in SEBT-PM between taping and bracing versus control: -2.4 95% CI -6 to 1.1; p = 0.18, and -7.5 95% CI -15.9 to 1; p = 0.08, respectively). This was also the case for sham taping because the measurement increase failed to exceed the minimal detectable change (percentage difference in SEBT-PM between sham taping and untreated control: -1.1 95% CI -6.9 to 4.7; p = 0.72). Importantly, there were no reported adverse events after treatment application.
Conclusions Evidence of moderate strength indicated that external supports of any type were no more effective than controls in improving dynamic postural control in patients with at least one ankle sprain and residual functional or mechanical deficits. Therefore, implementing those tools as a standalone treatment does not appear to be a viable strategy for the primary management of ankle instability. It is conceivable that combinations of rehabilitation and external supports could be more effective than external supports alone, and future trials should evaluate the potential of such combinations in enhancing not only clinician-reported but also patient-oriented outcomes using long-term follow-up measurements.
Level of Evidence Level I, therapeutic study.

CORR Insights®: Do External Supports Improve Dynamic Balance in Patients with Chronic Ankle Instability? A Network Meta-analysis

01-02-2020 – Guyton, Gregory P.

Journal Article

No abstract available

Does Intolerance of Uncertainty Affect the Magnitude of Limitations or Pain Intensity?

01-02-2020 – Donthula, Deepanjli; Kortlever, Joost T. P.; Ring, David; Donovan, Erin; Reichel, Lee M.; Vagner, Gregg A.

Journal Article

Background Intolerance of uncertainty—the tendency to overestimate the chance of and be unwilling to accept potential, but unlikely, negative outcomes in uncertain situations—is a cognitive construct that has been shown to affect symptoms and limitations for patients with traumatic and nontraumatic upper-extremity conditions. Cognitive flexibility and tolerance of uncertainty can be trained and practiced, with the potential to increase musculoskeletal health. However, to our knowledge, the degree to which intolerance of uncertainty might be associated with symptom intensity and the magnitude of limitations in adults with upper-extremity problems has not been characterized.
Questions/purposes After accounting for personal and social factors, is intolerance of uncertainty independently associated with (1) the magnitude of physical limitations and (2) pain intensity?Methods In this cross-sectional, observational study, 139 new and returning patients presenting to one of four orthopaedic offices in a large urban area completed the Intolerance of Uncertainty Scale (a validated measure of the level of comfort with uncertain situations), the Patient-reported Outcomes Measurement Information System—Physical Function Upper Extremity computer adaptive test (to measure the magnitude of limitations), and an 11-point ordinal measure of pain intensity. The mean age of the 139 participants was 51 years ± 16 years and 55% (76 of 139) were men. Participants presented to the clinics with a wide variety of upper-extremity conditions, such as trigger finger, distal radius fractures, lateral epicondylitis, or non-specific shoulder pain. We also assessed sex, race, marital status, education level, income, public versus private insurance, area deprivation index, and the participant’s self-perception of their healthcare experience through a multiple-choice question (answer choices: none, some, a little, and a lot of experience). The following patient characteristics were more common in our study participants: white, employed, part of a married or unmarried couple, and private insurance coverage. We created two multivariable linear regression models to assess factors independently associated with the magnitude of limitations and pain intensity.
Results After controlling for potentially confounding variables including sex, insurance, area deprivation index, and type of visit, we found that fewer physical limitations were associated with a greater intolerance of uncertainty (regression coefficient β -0.30; 95% confidence interval, -0.50 to -0.10; p = 0.003; semi-partial r2 = 0.07; adjusted r2 for the full model = 0.16), as was being a man (β 3.2; 95% CI, 0.08-6.3; p = 0.045; semi-partial r2 = 0.03) and having private insurance coverage (β 5.2; 95% CI, 2.1-8.2; p = 0.001; semi-partial r2 = 0.08). After controlling for one important potentially confounding variable, the level of education, greater pain intensity was associated with a greater intolerance of uncertainty (β 0.08; 95% CI, 0.02-0.14; p = 0.009; semi-partial r2 = 0.05; adjusted r2 for the full model = 0.08).
Conclusions Intolerance of uncertainty—a byproduct of cognitive bias and error, which are elements of the normal functioning of the human mind—increases limitations and pain intensity across diagnoses, independent of demographic and social factors. Future studies can address the effect of strategies that incorporate mindset training (for example, cognitive behavioral therapy and its derivatives) on musculoskeletal symptoms and limitations.
Level of Evidence Level II, prognostic study.

CORR Insights®: Does Intolerance of Uncertainty Affect the Magnitude of Limitations or Pain Intensity?

01-02-2020 – Vranceanu, Ana-Maria

Journal Article

No abstract available

What Is the Best Evidence for Management of Displaced Midshaft Clavicle Fractures? A Systematic Review and Network Meta-analysis of 22 Randomized Controlled Trials

01-02-2020 – Axelrod, Daniel E.; Ekhtiari, Seper; Bozzo, Anthony; Bhandari, Mohit; Johal, Herman

Journal Article

Background Displaced mid-third clavicle fractures are common, and their management remains unclear. Although several meta-analyses have compared specific operative techniques with nonoperative management, it is not possible to compare different operative constructs with one another using a standard meta-analysis. Conversely, a network meta-analysis allows comparisons among more than two treatment arms, using both direct and indirect comparisons between interventions across many trials. To our knowledge, no network meta-analysis has been performed to compare the multiple treatment options for displaced clavicle fractures.
Questions/purposes We performed a network meta-analysis of randomized, controlled trials (RCTs) to determine from among the approaches used to treat displaced midshaft clavicle fractures: (1) the intervention with the highest chance of union at 1 year, (2) the intervention with the lowest risk of revision surgery, and (3) the intervention with the highest functional outcome scores. Secondarily, we also (4) compared the surgical subtypes in the available RCTs on the same above endpoints.
Methods MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were reviewed for relevant randomized controlled trials published up to July 25, 2018. Two hundred and eighty four papers were reviewed, with 22 meeting inclusion criteria of RCTs with appropriate randomization techniques, adult population, minimum of 1 year follow-up and including at least one operative treatment arm. In total, 1002 patients were treated with a plate construct, 378 with an intramedullary device, and 585 patients were managed nonoperatively. Treatment subtypes included locked intramedullary devices (56), unlocked intramedullary devices (322), anterior plating (89), anterosuperior plating (150), superior plating (449) or plating not otherwise specified (314). We performed a network meta-analysis to compare and rank the treatments for displaced clavicle fractures. We considered the following outcomes: union achievement, revision surgery risk and functional outcomes (DASH and Constant Scores). The minimal clinically important difference (MCID) was considered for both Constant and DASH scores to be at 8 points, representing the average of MCID scores reported for both DASH and Constant in the evidence, respectively.
Results Union achievement was lower in patients treated nonoperatively (88.9%), and higher in patients treated operatively (96.7%, relative risk RR 1.128 95% CI 1.1 to 1.17; p < 0.001), Number needed to treat (NNT) = 10). Union achievement increased with any plate construct (97.8%, RR 1.13 95% CI 1.1 to 1.7; p < 0.0001, NNT = 9) and with anterior or anterosuperior plates (99.3%, RR 1.14 95% CI 1.1 to 1.8; p < 0.0001, NNT = 8). Risk of reoperation, when considering planned removal of hardware, was similar across all treatment arms. Lastly, operative treatment outperformed nonoperative treatment with minor improvements in DASH and Constant scores, though not approaching the MCID. At the subtype level, anterosuperior plating ranked highest in DASH and Constant functional scores with mean differences reaching 10-point improvement for Constant scores (95% CI 4.4 to 2.5) and 7.6 point improvement for DASH (95% CI 5.2 to 20).
Conclusions We found that surgical treatment led to a greater likelihood of union at 1 year of follow-up among adult patients with displaced mid-third clavicle fractures. In aggregate, surgical treatment did not increase functional scores by amounts that patients were likely to consider clinically important. Use of specific subtypes of plating (anterior, anterosuperior) resulted in improvements in the Constant score that were slightly above the MCID but did not reach the MCID for the DASH score, suggesting that any outcomes-score benefits favoring surgery were likely to be imperceptible or small. In light of these findings, we believe patients can be informed that surgery for this injury can increase the likelihood of union incrementally (about 10 patients would need to undergo surgery to avoid one nonunion), but they should not expect better function than they would achieve without surgery; most patients can avoid surgery altogether with little absolute risk of nonunion. Patients who opt for surgery must be told that the decision should be weighed against complications and the possibility of undergoing a second procedure for hardware removal. Patients opting not to have surgery for acute midshaft clavicle fractures can be told that nonunion occurs in slightly more than 10% of patients, and that these can be more difficult to manage than acute fractures.
Level of Evidence Level I, therapeutic study.

CORR Insights®: What Is the Best Evidence for Management of Displaced Midshaft Clavicle Fractures? A Systematic Review and Network Meta-analysis of 22 Randomized Controlled Trials

01-02-2020 – Ranalletta, Maximiliano

No abstract available

Postoperative Administration of Alpha-tocopherol Enhances Osseointegration of Stainless Steel Implants: An In Vivo Rat Model

01-02-2020 – Savvidis, Matthaios; Papavasiliou, Kyriakos; Taitzoglou, Ioannis; Giannakopoulou, Aggeliki; Kitridis, Dimitrios; Galanis, Nikiforos; Vrabas, Ioannis; Tsiridis, Eleftherios

Journal Article

Background Alpha-tocopherol, a well-known antioxidative agent, may have a positive effect on bone formation during the remodeling phase of secondary fracture healing. Fracture healing and osseointegration of implants share common biological pathways; hence, alpha-tocopherol may enhance implant osseointegration.
Questions/purposes This experimental study in rats assessed the ability of alpha-tocopherol to enhance osseointegration of orthopaedic implants as determined by (1) pull-out strength and removal torque and (2) a histomorphological assessment of bone formation. In addition, we asked, (3) is there a correlation between the administration of alpha-tocopherol and a reduction in postoperative oxidative stress (as determined by malondialdehyde, protein carbonyls, reduced and oxidized glutathione and their ratio, catalase activity and total antioxidant capacity) that develops after implantation of an orthopaedic implant?Methods This blinded study was performed in study and control groups, each consisting of 15 young adult male Wistar rats. On Day 0, a custom-designed stainless-steel screw was implanted in the proximal metaphysis of both tibias of all rats. On Day 1, animals were randomized to receive either alpha-tocopherol (40 mg/kg once per day intraperitoneally) or saline (controls). Animals were treated according to identical perioperative and postoperative protocols and were euthanized on Day 29. All animals completed the study and all tibias were suitable for evaluation. Implant pullout strength was assessed in the right tibias, and removal torque and histomorphometric evaluations (that is, volume of newly formed bone surrounding the implant in mm3, percentage of newly formed bone, percentage of bone marrow surrounding the implant per optical field, thickness of newly formed bone in μm, percentage of mineralized bone in newly formed bone, volume of mature newly formed bone surrounding the implant in mm3 and percentage of mineralized newly formed bone per tissue area) were performed in the left tibias. The plasma levels of alpha-tocopherol, malondialdehyde, protein carbonyls, glutathione, glutathione disulfide, catalase, and the total antioxidant capacity were evaluated, and the ratio of glutathione to oxidized glutathione was calculated.
Results All parameters were different between the alpha-tocopherol-treated and control rats, favoring those in the alpha-tocopherol group. The pullout strength for the alpha-tocopherol group (mean ± SD) was 124.9 ± 20.7 newtons (N) versus 88.1 ± 12.7 N in the control group (mean difference -36.7 95% CI -49.6 to -23.9; p < 0.001). The torque median value was 7 (range 5.4 to 8.3) versus 5.2 (range 3.6 to 6 ) N/cm (p < 0.001). The newly formed bone volume was 29.8 ± 5.7 X 10-3 versus 25.2 ± 7.8 X 10-3 mm3 (mean difference -4.6 95% CI -8.3 to -0.8; p = 0.018), the percentage of mineralized bone in newly formed bone was 74.6% ± 8.7% versus 62.1% ± 9.8% (mean difference -12.5 95% CI -20.2 to -4.8; p = 0.003), the percentage of mineralized newly formed bone per tissue area was 40.3 ± 8.6% versus 34.8 ± 9% (mean difference -5.5 95% CI -10.4 to -0.6; p = 0.028), the glutathione level was 2 ± 0.4 versus 1.3 ± 0.3 μmol/g of hemoglobin (mean difference -0.6 95% CI -0.9 to -0.4; p < 0.001), the median glutathione/oxidized glutathione ratio was 438.8 (range 298 to 553) versus 340.1 (range 212 to 454; p = 0.002), the catalase activity was 155.6 ± 44.6 versus 87.3 ± 25.2 U/mg Hb (mean difference -68.3 95% CI -95.4 to -41.2; p < 0.001), the malondialdehyde level was 0.07 ± 0.02 versus 0.14 ± 0.03 μmol/g protein (mean difference 0.07 95% CI 0.05 to 0.09; p < 0.001), the protein carbonyl level was 0.16 ± 0.04 versus 0.27 ± 0.08 nmol/mg of protein (mean difference -0.1 95% CI 0.05 to 0.15; p = 0.002), the alpha-tocopherol level was 3.9 ± 4.1 versus 0.9 ± 0.2 mg/d
L (mean difference -3 95% CI -5.2 to -0.7; p = 0.011), and the total antioxidant capacity was 15.9 ± 3.2 versus 13.7 ± 1.7 nmol 2,2-diphenyl-1-picrylhydrazyl radical/g of protein (mean difference -2.1 95% CI -4.1 to -0.18; p = 0.008).
Conclusions These results using an in vivo rat model support that postoperatively administered alpha-tocopherol can enhance the osseointegration of an orthopaedic implant, although a cause and effect relationship between the administration of alpha-tocopherol and a reduction in postoperative stress cannot be securely established.
Clinical Relevance These findings suggest that postoperative administration of alpha-tocopherol is a promising approach to enhance osseointegration of orthopaedic implants in patients. Further studies with different animal models and/or different implants and those evaluating the alpha-tocopherol dose response are needed before performing clinical trials that will examine whether these promising, preliminary results can be extrapolated to the clinical setting as well.

Does Vitamin D3 Prevent the Inhibitory Effect of Vancomycin on Osteoblasts?

01-02-2020 – Tsuji, Kentaro; Kimura, Soichiro; Tateda, Kazuhiro; Takahashi, Hiroshi

Journal Article

Background The utility of vancomycin powder to prevent surgical site infection, mainly in spinal surgery, has been widely examined, and the local administration of vancomycin powder to wounds has been reported to be effective in preventing surgical site infections after spine surgery. However, in vitro studies have shown that high local concentrations of vancomycin may inhibit osteogenesis, although it remains unclear how these high concentrations influence osteoblasts. No candidate drug has been reported to recover cytotoxicity with high concentrations of vancomycin, but we suggest that vitamin D3, which induces osteoblast proliferation, may be administrated concomitantly with vancomycin in these situations.
Questions/purposes (1) Does a high concentration of vancomycin reduce viable osteoblast numbers in cell culture compared with controls? (2) Does vitamin D3 administration confer a protective effect on osteoblasts when administered with continuous vancomycin? (3) Does vitamin D3 administration confer a protective effect on osteoblasts when administered with pulsed vancomycin (24 hours of administration)? (4) Does vitamin D3 administration confer alkaline phosphatase, mineralization, and gene expression when administered with pulsed vancomycin?Methods MC3T3-E1 cells were cultured at 37° C in an α-minimum essential medium supplemented with 10% fetal bovine serum in a humidified incubator containing 5% CO2. The experimental concentrations of vancomycin (2500 μg/m
L, 5000 μg/m
L, and 7500 μg/m
L) were determined based on previous reports and preliminary experiments. We concomitantly administered vitamin D3 (0.01 nM) to prevent cytotoxicity in osteoblasts, using two different treatments: continuous vancomycin administration (measured at 6 hours, 12 hours, 24 hours, and 72 hours) and pulsed vancomycin for 24 hours (measured at 1 days, 3 days, and 7 days). We analyzed cell numbers and morphologic changes in cells treated with vancomycin or vancomycin plus 0.01 nM vitamin D3. Osteoblast differentiation was assessed with alkaline phosphatase staining, alkaline phosphatase activity, and Alizarin red S staining.
Results The number of cells was reduced at 6 hours, 24 hours, 48 hours, and 72 hours in response to continuous vancomycin administration at 7500 µg/m
L (at 72 hours, control 14.6 × 104 cells/m
L ± 0.260 × 104 cells/m
L, vancomycin at 0.917 × 104 cells/m
L ± 0.288 × 104 cells/m
L, mean difference -13.7 × 104 cells/m
L ± 0.388 × 104 cells/m
L 95% CI -14.5 to -12.9; p < 0.001). Vitamin D3 did not have a protective effect when vancomycin was administered continuously at 7500 µg/m
L (at 72 hours, vancomycin alone 0.917 × 104 cells/m
L ± 0.288 × 104 cells/m
L, vancomycin + vitamin D3 1.67 × 104 cells/m
L ± 0.310 × 104 cells/m
L, mean difference 0.75 × 104 cells/m
L ± 0.423 × 104 cells/m
L 95% CI -0.127 to 1.63; p = 0.09).
With pulsed administration for only the first 24 hours, the number of cells was reduced at 1 day, 3 days, and 7 days at 7500 μg/m
L (at 7 days, control 18.6 × 104 cells/m
L ± 1.29 × 104 cells/m
L, vancomycin at 3.46 × 104 cells/m
L ± 0.292 × 104 cells/m
L, mean difference -15.1 × 104 cells/m
L ±1.33 × 104 cells/m
L 95% CI -17.9 to -12.4; p < 0.001 for all). However, vitamin D3 had a recovery effect when vancomycin was administered only for 24 hours (cell number with 7500 μg/m
L, day 7: vancomycin alone 3.46 × 104 cells/m
L ± 0.292 × 104 cells/m
L, vancomycin +vitamin D3 10.6 × 104 cells/m
L ± 0.900 × 104 cells/m
L, mean difference 7.13 × 104 cells/m
L ± 0.946 × 104 cells/m
L 95% CI 5.16 to 9.09; p < 0.001).
With the addition of vitamin D3, we observed recovery of alkaline phosphatase staining and Alizarin red staining (evidence of calcification) but no difference in the gene expression of Type I collagen (vancomycin alone 0.319 ± 0.0730, vancomycin + vitamin D3 0.511 ± 0.139, mean difference 0.192 ± 0.157 95% CI -0.483 to 0.867; p = 0.345), alkaline phosphatase (vancomycin alone 0.532 ± 0.0210, vancomycin + vitamin D3 0.785 ± 0.0590, mean difference 0.253 ± 0.0620 95% CI -0.0150 to 0.521; p = 0.0550), and cathelicidin antimicrobial peptide (vancomycin alone 0.885 ± 0.0520, vancomycin + vitamin D3 1.24 ± 0.125, mean difference 0.355 ± 0.135 95% CI -0.0200 to 0.730; p = 0.0580).
Conclusion We found that 7500 µg/m
L of vancomycin is cytotoxic to osteoblasts. Cytotoxicity could be prevented by administering vitamin D3 in combination with vancomycin.
Clinical Relevance The high concentrations of vancomycin routinely used clinically raises concerns related to osteoblast cytotoxicity, which may contribute to pseudoarthrosis after spinal surgery. Thus, vitamin D3, which is frequently used to treat osteoporosis, may have efficacy as a concomitantly administered drug by inducing the proliferation of osteoblasts. These results indicate that a combination therapy of vancomycin and vitamin D3 may prevent adverse events such as osteoblast cytotoxicity.

Classifications in Brief: AO Thoracolumbar Classification System

01-02-2020 – Vu, Catphuong; Gendelberg, David

Journal Article

No abstract available

RETRACTED ARTICLE: Are There Gender Differences Among Leaders of Regional Orthopaedic Societies of the United States?

01-02-2020 – Gwam, Chukwuweike U.; Rosas, Samuel; Xiao, Ted; Dawkins, Artina; Sullivan, Rashad J.; Emory, Cynthia L.

No abstract available

EXPRESSION OF CONCERN. CORR Insights®: Are There Gender Differences Among Leaders of Regional Orthopaedic Societies of the United States?

01-02-2020 – Baumhauer, Judith F.

No abstract available

Erratum to: Reply to the Letter to the Editor: Translation and Validation of the German New Knee Society Scoring System

01-02-2020 – Kayaalp, Mahmut Enes; Becker, Roland

No abstract available

Letter to the Editor: Editorial: What is Narrative Medicine, and Why Should We Use it in Orthopaedic Practice?

01-02-2020 – Wald, Hedy S.

Journal Article

No abstract available