Surgery, Needle Fasciotomy, or Collagenase Injection for Dupuytren Contracture : A Randomized Controlled Trial.

BACKGROUND: Surgery, needle fasciotomy, and collagenase injection are used to treat Dupuytren contracture. The treatment decision requires balancing initial morbidity and costs of surgery against its potential long-term benefits over needle fasciotomy and collagenase. OBJECTIVE: To compare the effectiveness of surgery, needle fasciotomy, and collagenase injection at 3 months and 2 years (secondary time points of the trial). DESIGN: A multicenter, randomized, outcome assessor-blinded, superiority trial. (ClinicalTrials.gov: NCT03192020). SETTING: 6 public hospitals in Finland. PARTICIPANTS: 302 persons with treatment-naive Dupuytren contracture (contracture angle <135°). INTERVENTION: Surgery (n = 101), needle fasciotomy (n = 101), or collagenase (n = 100). MEASUREMENTS: The primary outcome was the success rate, defined as greater than 50% contracture release and patients reaching the patient acceptable symptom state. Secondary outcomes included hand function, pain, quality of life, patient satisfaction, residual contracture angle, finger flexion, risk for retreatment, and serious adverse events. RESULTS: A total of 292 (97%) and 284 (94%) participants completed the 3-month and 2-year follow-ups. Success rates were similar at 3 months: 71% (95% CI, 62% to 80%) for surgery, 73% (CI, 64% to 82%) for needle fasciotomy, and 73% (CI, 64% to 82%) for collagenase. At 2 years, surgery had superior success rates compared with both needle fasciotomy (78% vs. 50%; adjusted risk difference [aRD], 0.30 [CI, 0.17 to 0.43]) and collagenase (78% vs. 65%; aRD, 0.13 [CI, 0.01 to 0.26]). Secondary analyses paralleled with the primary analysis. LIMITATION: Participants were not blinded. CONCLUSION: Initial outcomes are similar between the treatments, but at 2 years success rates were maintained in the surgery group but were lower with both needle fasciotomy and collagenase despite retreatments. PRIMARY FUNDING SOURCE: Research Council of Finland.

Early Predictors of Recovery From Nonoperatively Treated Achilles Tendon Rupture: 1 Year Follow-Up Study.

PURPOSE: To investigate early structural and mechanical predictors of plantarflexor muscle strength and the magnitude of Achilles tendon (AT) nonuniform displacement at 6 and 12 months after AT rupture. METHODS: Thirty-five participants (28 males and 7 females; mean ± SD age 41.7 ± 11.1 years) were assessed for isometric plantarflexion maximal voluntary contraction (MVC) and AT nonuniformity at 6 and 12 months after rupture. Structural and mechanical AT and plantarflexor muscle properties were measured at 2 months. Limb asymmetry index (LSI) was calculated for all variables. Multiple linear regression was used with the 6 and 12 month MVC LSI and 12 month AT nonuniformity LSI as dependent variables and AT and plantarflexor muscle properties at 2 months as independent variables. The level of pre- and post-injury sports participation was inquired using Tegner score at 2 and 12 months (scale 0-10, 10 = best possible score). Subjective perception of recovery was assessed with Achilles tendon total rupture score (ATRS) at 12 months (scale 0-100, 100=best possible score). RESULTS: Achilles tendon resting angle (ATRA) symmetry at 2 months predicted MVC symmetry at 6 and 12 months after rupture (ß = 2.530, 95% CI 1.041-4.018, adjusted R2 = 0.416, p = 0.002; ß = 1.659, 95% CI 0.330-2.988, adjusted R2 = 0.418, p = 0.016, respectively). At 12 months, participants had recovered their pre-injury level of sports participation (Tegner 6 ± 2 points). The median (IQR) ATRS score was 92 (7) points at 12 months. CONCLUSION: Greater asymmetry of ATRA in the early recovery phase may be a predictor of plantarflexor muscle strength deficits up to 1 year after rupture. TRIAL REGISTRATION: This research is a part of "nonoperative treatment of Achilles tendon rupture in Central Finland: a prospective cohort study" that has been registered in ClinicalTrials.gov (NCT03704532).

Clinical Outcomes After Revision Hip Arthroplasty due to Prosthetic Joint Infection-A Single-Center Study of 369 Hips at a High-Volume Center With a Minimum of One Year Follow-Up.

BACKGROUND: Prosthetic joint infection (PJI) treatment decisions are traditionally based on treatment algorithms. There is, however, a lack of evidence to support the choice of these treatment algorithms. Therefore, we aimed to assess the one-year survival after PJI revision and compared different surgical strategies in a single-center setting. METHODS: Revisions of the hip due to PJI performed at our institution between January 2008 and September 2021 with at least one-year of follow-up were identified. In total, 134 debridement, antibiotics, and implant retentions (DAIRs), 114 one-stage revisions, and 121 two-stage revisions were performed. Infections were classified as early, acute hematogenous, and chronic. Survival was calculated using the Kaplan-Meier method and cumulative incidence function. Predictors of outcomes were examined with Fine-Gray regressions and Cox proportional hazards regressions. Subdistribution hazard ratios and hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated. RESULTS: At one-year follow-up, 26.6% (CI 22.2 to 31.2%) of the patients had undergone reoperation and 7.9% (CI 5.4 to 10.9%) had died. The risk for reoperation was highest after DAIR (36.6%, CI 28.5 to 44.7%) and lowest after one-stage revision (20.2%, CI 13.4 to 28%). Within the early infections, the one-stage revision almost halved the risk of reoperation (HR 0.51, CI 0.31 to 0.84) with no added mortality risk (HR 1.05, CI 0.5 to 2.2), when compared to DAIR. CONCLUSION: By utilizing 1-stage revision over DAIR in early infections, it might be possible to improve the prognosis by decreasing the risk of reoperation without increasing mortality. However, as the patient selection is undeniably difficult, more research is warranted.

Complications and secondary operations after non-operative and operative treatment of tibial plateau fractures: a population-based study of 562 patients with mean follow-up of 7 years.

INTRODUCTION: The incidence of tibial plateau fractures (TPF) is 1% of all fractures and increases with age. Whether non-operatively or operatively treated, complications (infection, malalignment, loss of reduction and delayed union or nonunion) and post-traumatic osteoarthritis are not uncommon, and the risk for complications has generally been assumed to rise with age. This study investigated all post-TPF complications and secondary surgery after non-operative and operative treatment. Secondary aims were to determine the incidence and epidemiology of TPF in the population of the Central Finland region. MATERIALS AND METHODS: All patients over age 18 years with a TPF, including incidence, etiology, fracture type, and possible complications and reoperations, sustained during the period 1998-2019 were retrospectively identified from hospital records. RESULTS: The annual mean incidence of TPF was 14.4/100,000, with older women at highest risk. The proportions of non-operative and operatively treated patients who had undergone at least one additional surgical operation were 6% and 26%, respectively. Age and female gender were identified as risk factors for complications and secondary operations. The risk peaked in patients aged 60-65 years, decreasing thereafter. Non-operative treatment showed low risk for both non-union and loss of reduction. CONCLUSIONS: Older women were at the highest risk for TPF and for subsequent complications and secondary operations after TPF. Secondary operations after operatively treated TPF were not uncommon and patients aged 60-65 years were at highest risk. Given the low rates of complications and re-operations, non-operative treatment may be a safe option in cases of all minimally displaced TPF.

Surgery with locking plate or hemiarthroplasty versus nonoperative treatment of 3-4-part proximal humerus fractures in older patients (NITEP): An open-label randomized trial.

BACKGROUND: Proximal humerus fractures (PHFs) are common fractures, especially in older female patients. These fractures are commonly treated surgically, but the consensus on the best treatment is still lacking. METHODS AND FINDINGS: The primary aim of this multicenter, randomized 3-arm superiority, open-label trial was to assess the results of nonoperative treatment and operative treatment either with locking plate (LP) or hemiarthroplasty (HA) of 3- and 4-part PHF with the primary outcome of Disabilities of the Arm, Shoulder, and Hand (DASH) at 2-year follow-up. Between February 2011 and December 2019, 160 patients 60 years and older with 3- and 4-part PHFs were randomly assigned in 1:1:1 fashion in block size of 10 to undergo nonoperative treatment (control) or operative intervention with LP or HA. In total, 54 patients were assigned to the nonoperative group, 52 to the LP group, and 54 to the HA group. Five patients assigned to the LP group were reassigned to the HA group perioperatively due to high comminution, and all of these patients had 4-part fractures. In the intention-to-treat analysis, there were 42 patients in the nonoperative group, 44 in the LP group, and 37 in the HA group. The outcome assessors were blinded to the study group. The mean DASH score at 2-year follow-up was 30.4 (standard error (SE) 3.25), 31.4 (SE 3.11), and 26.6 (SE 3.23) points for the nonoperative, LP, and HA groups, respectively. At 2 years, the between-group differences were 1.07 points (95% CI [-9.5,11.7]; p = 0.97) between nonoperative and LP, 3.78 points (95% CI [-7.0,14.6]; p = 0.69) between nonoperative and HA, and 4.84 points (95% CI [-5.7,15.4]; p = 0.53) between LP and HA. No significant differences in primary or secondary outcomes were seen in stratified age groups (60 to 70 years and 71 years and over). At 2 years, we found 30 complications (3/52, 5.8% in nonoperative; 22/49, 45% in LP; and 5/49, 10% in HA group, p = 0.0004) and 16 severe pain-related adverse events. There was a revision rate of 22% in the LP group. The limitation of the trial was that the recruitment period was longer than expected due to a high number of exclusions after the assessment of eligibility and a larger exclusion rate than anticipated toward the end of the trial. Therefore, the trial was ended prematurely. CONCLUSIONS: In this study, no benefit was observed between operative treatment with LP or HA and nonoperative treatment in displaced 3- and 4-part PHFs in patients aged 60 years and older. Further, we observed a high rate of complications related to operative treatments. TRIAL REGISTRATION: ClinicalTrials.gov NCT01246167.

Is Replantation Associated With Better Hand Function After Traumatic Hand Amputation Than After Revision Amputation?

BACKGROUND: Replantation is an established treatment for traumatic upper extremity amputation. Only a few studies, however, have assessed the patient-reported outcomes of replantation, and the findings of these studies have been conflicting. QUESTIONS/PURPOSES: (1) Is replantation associated with better hand function than revision amputation? (2) Is replantation associated with better health-related quality of life, less painful cold intolerance, and more pleasing hand esthetics than revision amputation after a traumatic hand amputation? METHODS: In this retrospective, comparative study, we collected the details of all patients who sustained a traumatic upper extremity amputation and were treated at the study hospital. Between 2009 and 2019, we treated 2250 patients, and we considered all patients who sustained a traumatic amputation of two or more digital rays or a thumb as potentially eligible. Based on that, 15% (334 of 2250) were eligible; a further 2% (8 of 334) were excluded because of a subsequent new traumatic amputation or bilateral amputation, and another 22% (72 of 334) refused participation, leaving 76% (254 of 334) for analysis here. The primary outcome was the DASH score. Secondary outcomes included health-related quality of life (EuroQOL-5D [EQ-5D-5L] Index), painful cold intolerance (the Cold Intolerance Symptom Severity score), and hand esthetics (the Michigan Hand Questionnaire aesthetic domain score). The minimum follow-up time for inclusion was 18 months. Patients were classified into two treatment groups: replantation (67% [171 of 254], including successful replantation in 84% [144 of 171] and partially successful replantation in 16% [27 of 171], in which some but not all of the replanted tissue survived), and revision (complete) amputation (33% [83 of 254], including primary revision amputation in 70% [58 of 83] and unsuccessful replantation followed by secondary amputation in 30% [25 of 83]). In this cohort, replantation was performed if possible, and the reason for choosing primary revision amputation over replantation was usually an amputated part that was too severely damaged (15% [39 of 254]) or was unattainable (2% [4 of 254]). Some patients (3% [8 of 254]) refused to undergo replantation, or their health status did not allow replantation surgery and postoperative rehabilitation (3% [7 of 254]). Gender, age (mean 48 ± 17 years in the replantation group versus 50 ± 23 years in the revision amputation group; p = 0.41), follow-up time (8 ± 4 years in the replantation group versus 7 ± 4 years in the revision amputation group; p = 0.18), amputation of the dominant hand, smoking, extent of tissue loss, or presence of arterial hypertension did not differ between the groups. Patients in the replantation group less frequently had diabetes mellitus (5% [8 of 171] versus 12% [10 of 83]; p = 0.03) and dyslipidemia (4% [7 of 171] versus 11% [9 of 83]; p = 0.04) than those in the revision group and more often had cut-type injuries (75% [129 of 171] versus 60% [50 of 83]; p = 0.02). RESULTS: After controlling for potential confounding variables such as age, injury type, extent of tissue loss before treatment, and accident of the dominant hand, replantation was not associated with better DASH scores than revision amputation (OR 0.82 [95% confidence interval (CI) 0.50 to 1.33]; p = 0.42). After controlling for potential cofounding variables, replantation was not associated with better EQ-5D-5L Index scores (OR 0.93 [95% CI 0.56 to 1.55]; p = 0.55), differences in Cold Intolerance Symptom Severity scores (OR 0.85 [95% CI 0.51 to 1.44]; p = 0.79), or superior Michigan Hand Questionnaire esthetic domain scores (OR 0.73 [95% CI 0.43 to 1.26]; p = 0.26) compared with revision amputation. CONCLUSION: Replantation surgery was conducted, if feasible, in a homogenous cohort of patients who underwent amputation. If the amputated tissue was too severely damaged or replantation surgery was unsuccessful, the treatment resulted in revision (complete) amputation, which was not associated with worse patient-reported outcomes than successful replantation. These results contradict the assumed benefits of replantation surgery and indicate the need for credible evidence to better guide the care of these patients. LEVEL OF EVIDENCE: Level III, therapeutic study.

Meniscal allograft transplantation improves patient-reported outcomes in both minimal and moderate knee osteoarthritis at 1 and 2 years postoperatively.

PURPOSE: Severe cartilage damage and advanced knee osteoarthritis (OA) might be associated with poor outcomes of meniscal allograft transplantation (MAT). The purpose of this prospective follow-up study was to explore MAT survivorship and patient satisfaction among young patients with symptomatic meniscal deficiency and radiological OA of different Kellgren-Lawrence (K-L) grades. METHODS: Thirty-five consecutive MAT patients were prospectively followed up for 2 years. The lateral meniscus was replaced in 29 patients and the medial meniscus in 6 patients. Outcomes were assessed using the KOOS4 composite score, KOOS subscales, Lysholm knee score, and OA K-L grade progression from weight-bearing knee radiographs. For the outcome analysis, patients were categorized into two groups: 19 in Group A (K-L classification 0-1) and 16 in Group B (K-L classification 2). RESULTS: In terms of KOOS4 and Lysholm scores, the patients showed a clinically significant improvement from baseline to the 1-year follow-up (22.2 points, 95% CI 16.6-27.8 for KOOS4 and 16.8 points, 95% CI 8.9-24.6 for Lysholm), and the improvement remained at 2 years (20.6 points, 95% CI 13.2-28.1 for KOOS4 and 21.5, 95% CI 12.5-30.7 for Lysholm). At the 6-month follow-up, this improvement was not yet observed. Minor between-group differences were observed in the KOOS4 and Lysholm scores for the K-L 0-1 and K-L 2 OA groups, but the estimates were imprecise with wide confidence intervals. A clinically relevant difference between these two study groups could not be found at any timepoint. The reoperation rate was higher in the K-L 2 group than in the K-L 0-1 group (31% vs. 11%). CONCLUSIONS: MAT yielded improved patient-reported outcomes and subjective satisfaction at 1 and 2 years postoperatively. The differences from baseline exceeded the minimal clinically important difference (MCID) at all timepoints. The severity of cartilage damage and knee OA in terms of the K-L grade at the time of surgery did not affect the KOOS and Lysholm scores after the MAT procedure. Knee OA progression in terms of K-L grade worsening was not observed in any patients. LEVEL OF EVIDENCE: III.

KLIC Score Does Not Predict Failure After Early Prosthetic Joint Infection: An External Validation With 153 Knees and 130 Hips.

BACKGROUND: A preoperative risk score, the KLIC score (chronic renal failure [K], liver cirrhosis [L], indication of the index surgery [I], cemented prosthesis [C], and C-reactive protein >115 mg/L), has been developed to predict the risk of treatment failure after early prosthetic joint infection (PJI). This study aimed to validate the KLIC score for the debridement, antibiotics, and implant retention (DAIR) procedure and one-stage revisions in a Northern European cohort. METHODS: Revisions due to early PJI of the hip or knee between January 1, 2008, and September 12, 2021, were identified retrospectively. The primary outcome was early failure, which was considered when the patient needed an unscheduled surgery, the patient died, or the patient was prescribed long-term suppressive antibiotics. To examine the association between KLIC score and failure risk, univariable logistic regression with area under the curve (AUC) was used. In addition, models were calibrated to assess prognostic ability and clinical utility was examined with decision-curve analyses. RESULTS: An increase in KLIC score had a moderate predictive value for early failure after DAIR (odds ratio [OR] 1.45; confidence interval [CI] 1.13 to 1.90). For one-stage revision, it was only slightly predictive of failure (OR 1.20; CI 0.93 to 1.56). After 60 days, the AUC for DAIR was 0.63 (CI 0.55 to 0.72) and 0.56 (CI 0.46 to 0.66) for one-stage revisions, indicating poor discriminative ability. The decision-curve analyses revealed that the model did not offer a remarkable net benefit across a range of threshold probabilities. CONCLUSIONS: We demonstrated that the KLIC score is not a reliable predictor of early failure after early PJI in a Northern European cohort. Using the model to guide treatment decisions does not provide any additional clinical utility beyond the baseline strategies.

Trends in Revision Knee Arthroplasty for Prosthetic Joint Infection: A Single-Center Study of 384 Knees at a High-Volume Center Between 2008 and 2021.

BACKGROUND: Prosthetic joint infection (PJI) is one of the most devastating complications after total knee arthroplasty (TKA), and comorbidities increase the risk. We examined whether a temporal change has occurred in the demographics, especially regarding comorbidities, of patients who have PJI and were treated at our institution over a 13-year study period. In addition, we assessed the surgical methods used and the microbiology of the PJIs. METHODS: Revisions (n = 384, 377 patients) due to PJI of the knee performed at our institution between 2008 and September 2021 were identified. All included PJIs fulfilled the 2013 International Consensus Meeting diagnostic criteria. The surgeries were categorized into one of the following categories: debridement, antibiotics, and retention (DAIR), 1-stage revision, and 2-stage revision. Infections were classified as early, acute hematogenous, and chronic. RESULTS: No changes in the median age of the patients nor comorbidity burden were observed during the study period. However, the proportion of 2-stage revisions decreased remarkably from 57.6% in 2008 to 2009 to 6.3% in 2020 to 2021. A DAIR was the most used treatment strategy, but the proportion of 1-stage revisions increased the most. In 2008 to 2009, 12.1% of the revisions were 1-stage, but in 2020 to 2021, the proportion was 43.8%. The most common pathogen was Staphylococcus aureus (27.8%). CONCLUSION: The comorbidity burden remained at the same level with no trends. A DAIR was the most used strategy, but the proportion of 1-stage revisions rose to almost the same level. The incidence of PJI varied between the years, but remained relatively low.

Trends in Revision Hip Arthroplasty for Prosthetic Joint Infection: A Single-Center Study of 423 Hips at a High-Volume Center Between 2008 and 2021.

BACKGROUND: Prosthetic joint infection (PJI) is one of the most devastating complications after total hip arthroplasty (THA), and comorbidities increase the risk. We examined whether there was a temporal change in the demographics, especially regarding comorbidities, of patients who have PJIs and were treated over a 13-year study period at a high-volume academic joint arthroplasty center. In addition, the surgical methods used and the microbiology of the PJIs were assessed. METHODS: Revisions (n = 423, 418 patients) due to PJI of the hip performed at our institution between 2008 and September 2021 were identified. All included PJIs fulfilled the 2013 International Consensus Meeting diagnostic criteria. The surgeries were categorized into one of the following categories: debridement, antibiotics, and implant retention, 1-stage revision, and 2-stage revision. Infections were classified as early, acute hematogenous, and chronic infections. RESULTS: There was no change in the median age of the patients, but the proportion of ASA-class 4 patients increased from 10.5% to 20%. The incidence of early infections increased from 0.11 per 100 primary THAs in 2008 to 1.09 in 2021. The incidence of 1-stage revisions increased the most, rising from 0.10 per 100 primary THAs in 2010 to 0.91 per 100 primary THAs in 2021. Furthermore, the proportion of infections caused by Staphylococcus aureus increased from 26.3% in 2008 to 2009 to 40% in 2020 to 2021. CONCLUSION: The comorbidity burden of PJI patients increased during the study period. This increase may present a treatment challenge, as comorbidities are known to have a negative effect on PJI treatment outcomes.

Persistent Tennis Elbow Symptoms Have Little Prognostic Value: A Systematic Review and Meta-analysis.

BACKGROUND: Tennis elbow is a common painful enthesopathy of the lateral elbow that limits upper limb function and frequently results in lost time at work. Surgeons often recommend surgery if symptoms persist despite nonsurgical management, but operations for tennis elbow are inconsistent in their efficacy, and what we know about those operations often derives from observational studies that assume the condition does not continue to improve over time. This assumption is largely untested, and it may not be true; meta-analyzing results from the control arms of tennis elbow studies can help us to evaluate this premise, but to our knowledge, this has not been done. QUESTIONS/PURPOSES: The aims of this systematic review were to describe the course of (1) global improvement, (2) pain, and (3) disability in participants who received no active treatment (placebo or no treatment) in published randomized controlled trials (RCTs) on tennis elbow. We also assessed (4) whether the duration of symptoms or placebo effect is associated with differences in symptom trajectories. METHODS: We searched MEDLINE, Embase, and CENTRAL from database inception to August 12, 2019, for trials including participants with tennis elbow and a placebo or a no-treatment arm and a minimum follow-up duration of 6 months. There were no language restrictions or exclusion criteria. We extracted global improvement, pain, and disability outcomes. We used the Cochrane Risk of Bias tool to assess the risk of bias of included trials. To estimate the typical course of tennis elbow without active treatment, we pooled global improvement (the proportion of participants who reported feeling much better or completely recovered), mean pain, and mean disability using baseline, 1-month, 3-month, 6-month, and 12-month follow-up data. We transformed pain and disability data from the original papers so that at each timepoint the relevant outcome was expressed as change relative to baseline to account for different baseline values. We used meta-regression to assess whether the placebo effect or duration of symptoms before enrollment was associated with differences in symptom trajectories. We included 24 trials with 1085 participants who received no active treatment. RESULTS: The number of patients who were not improved decreased exponentially over time. The half-life of global improvement was between 2.5 and 3 months (that is, every 2.5 to 3 months, 50% of the remaining symptomatic patients reported complete recovery or greatly improved symptoms). At 1 year, 89% (189 of 213; 95% CI 80% to 97%) of patients experienced global improvement. The mean pain and disability followed a similar pattern, halving every 3 to 4 months. Eighty-eight percent of pain (95% CI 70% to 100%) and 85% of disability (95% CI 60% to 100%) had resolved by 1 year. The mean duration of symptoms before trial enrollment was not associated with differences in symptom trajectories. The trajectories of the no-treatment and placebo arms were similar, indicating that the placebo effect of the studied active treatments likely is negligible. CONCLUSION: Based on the placebo or no-treatment control arms of randomized trials, about 90% of people with untreated tennis elbow achieve symptom resolution at 1 year. The probability of resolution appears to remain constant throughout the first year of follow-up and does not depend on previous symptom duration, undermining the rationale that surgery is appropriate if symptoms persist beyond a certain point of time. We recommend that clinicians inform people who are frustrated with persisting symptoms that this is not a cause for apprehension, given that spontaneous improvement is about as likely during the subsequent few months as it was early after the symptoms first appeared. Because of the high likelihood of spontaneous recovery, any active intervention needs to be justified by high levels of early efficacy and little or no risk to outperform watchful waiting. LEVEL OF EVIDENCE: Level I, therapeutic study.

'No Effect' Conclusions in Studies Reporting Nonsignificant Results Are Potentially Incorrect.

PURPOSE: To examine the spectrum of effect sizes in line with "no effect" claims in clinical studies published in high-impact orthopaedic journals. METHODS: Eight orthopaedic journals with the highest impact factors for 2018 were included in this study. The titles and abstracts of all journal articles published in these journals in 2019 were screened for no-effect statements. The effect sizes for effects claimed to be no effect were calculated. The asymmetry of 95% confidence interval (CI) tails of effect estimated in relation to 0 was examined by calculating the ratio between the tail lengths. RESULTS: The analysis included 255 articles reporting coefficients sufficiently. The median Cohen's d value was 0.15 (interquartile range [IQR] 0.06 to 0.25) in the studies comparing means and the median ϕ value in the studies comparing frequency distributions was 0.06 (IQR 0.04 to 0.15). In studies reporting odds ratios or hazard ratios, the median estimate value was 1.16 (IQR 1.09 to 1.34). The median asymmetry ratio for all studies was 1.9 (IQR 1.3 to 4.0). Asymmetry ratio values exceeded 5 in 55 studies (22%). CONCLUSIONS: No-effect statements are used for a wide variety of observed effects. Despite the conclusion of no effect, observed effects advocated toward actual effects. In addition, many cases in which the asymmetry of CIs related to the 0-effect estimate showed a high tendency of effect direction. CLINICAL RELEVANCE: Rather than emphasizing dichotomized interpretation of statistical inference, reporting observed coefficients with elaboration of related uncertainty and compatibility with meaningful effect sizes in the specific context is encouraged.

Performance of thin Vivacit-E hip liners: no relevant wear during ex vivo testing at high acetabular inclination angle.

BACKGROUND AND PURPOSE: There is concern among clinicians regarding the performance of thin, highly cross-linked polyethylene acetabular liners at high inclination angles that cause edge contact and high contact stresses. We studied ex vivo wear performance of thin, vitamin-E grafted, highly cross-linked polyethylene (Vivacit-E) liners in relation to high acetabular inclination angle. MATERIALS AND METHODS: Wear of Vivacit-E acetabular liners (thickness 4.0-5.7 mm) was studied with a validated hip joint simulator at 2 different acetabular inclination angles, 40° (optimal) and 65° (high). The test simulated walking. Wear was evaluated gravimetrically and dimensionally. RESULTS: At the optimal inclination angle, slight weight gain occurred. At the high angle, the liners lost weight slightly. Due to the minimal weight loss, gravimetric wear rates were difficult to determine. Linear wear was below the detection limit of 0.01 mm. CONCLUSION: Even with the high acetabular inclination angle, the prostheses performed well in the present test conditions. The wear rates of the liners were estimated to be clearly below the osteolysis threshold of 0.05 mm/year, below which osteolysis is absent. Since the present hip joint simulator has been shown to produce clinically relevant wear, these ex vivo results are likely to reflect the in vivo behavior of the design.

Study protocol: Prosthesis versus Active (ProAct) exercise program in patients with glenohumeral osteoarthritis - a multicenter, randomized controlled trial.

BACKGROUND AND PURPOSE: Total shoulder arthroplasty (TSA) and shoulder exercises are both effective treatments for reducing pain and improving function in glenohumeral osteoarthritis. However, the effectiveness of TSA has not been compared with non-surgical treatment in a randomized controlled trial. We will examine whether TSA followed bystandard postsurgical rehabilitation is superior to a 12-week exercise program in patients with primary glenohumeral OA who are eligible for unilateral TSA. PATIENTS AND METHODS: In this Nordic multicenter randomized controlled clinical trial, patients with glenohumeral osteoarthritis eligible for TSA will be allocated to either TSA followed by usual care or exercise only. The exercise intervention comprises 12 weeks of exercise with one weekly physiotherapist-supervised session. Based on the sample size calculation, the trial needs to include 102 patients. Duration and outcome:  Recruitment was initiated in April 2021 and is expected to be completed by the end of March 2024. Primary outcome is patient-reported quality of life, measured as total WOOS score 12 months after initiation of treatment. The key secondary outcomes include patient-reported pain intensity at rest and during activity; Disabilities of the Arm, Shoulder, and Hand score (DASH); the use of analgesics during the previous week; and adverse events. TRIAL REGISTRATION: The trial is approved by the Central Denmark Region Committee on Biomedical Research Ethics (Journal No 1-10-72-29-21) and by the Danish Data Protection Agency (Journal No 1-16-02-199-21). ClinicalTrials.gov Identifier: NCT04845074.

Estimates of the mean difference in orthopaedic randomized trials: obligatory yet obscure.

BACKGROUND: Randomized controlled trials in orthopaedics are powered to mainly find large effect sizes. A possible discrepancy between the estimated and the real mean difference is a challenge for statistical inference based on p-values. We explored the justifications of the mean difference estimates used in power calculations. The assessment of distribution of observations in the primary outcome and the possibility of ceiling effects were also assessed. METHODS: Systematic review of the randomized controlled trials with power calculations in eight clinical orthopaedic journals published between 2016 and 2019. Trials with one continuous primary outcome and 1:1 allocation were eligible. Rationales and references for the mean difference estimate were recorded from the Methods sections. The possibility of ceiling effect was addressed by the assessment of the weighted mean and standard deviation of the primary outcome and its elaboration in the Discussion section of each RCT where available. RESULTS: 264 trials were included in this study. Of these, 108 (41 %) trials provided some rationale or reference for the mean difference estimate. The most common rationales or references for the estimate of mean difference were minimal clinical important difference (16 %), observational studies on the same subject (8 %) and the 'clinical relevance' of the authors (6 %). In a third of the trials, the weighted mean plus 1 standard deviation of the primary outcome reached over the best value in the patient-reported outcome measure scale, indicating the possibility of ceiling effect in the outcome. CONCLUSIONS: The chosen mean difference estimates in power calculations are rarely properly justified in orthopaedic trials. In general, trials with a patient-reported outcome measure as the primary outcome do not assess or report the possibility of the ceiling effect in the primary outcome or elaborate further in the Discussion section.

Non-uniform displacement within ruptured Achilles tendon during isometric contraction.

The purpose of this study was investigate tendon displacement patterns in non-surgically treated patients 14 months after acute Achilles tendon rupture (ATR) and to classify patients into groups based on their Achilles tendon (AT) displacement patterns. Twenty patients were tested. Sagittal images of AT were acquired using B-mode ultrasonography during ramp contractions at a torque level corresponding to 30% of the maximal isometric plantarflexion torque of the uninjured limb. A speckle tracking algorithm was used to track proximal-distal movement of the tendon tissue at 6 antero-posterior locations. Two-way repeated measures ANOVA for peak tendon displacement was performed. K-means clustering was used to classify patients according to AT displacement patterns. The difference in peak relative displacement across locations was larger in the uninjured (1.29 ± 0.87 mm) than the injured limb (0.69 ± 0.68 mm), with a mean difference (95% CI) of 0.60 mm (0.14-1.05 mm, P < .001) between limbs. For the uninjured limb, cluster analysis formed 3 groups, while 2 groups were formed for the injured limb. The three distinct patterns of AT displacement during isometric plantarflexion in the uninjured limb may arise from subject-specific anatomical variations of AT sub-tendons, while the two patterns in the injured limb may reflect differential recovery after ATR with non-surgical treatment. Subject-specific tendon characteristics are a vital determinant of stress distribution across the tendon. Changes in stress distribution may lead to variation in the location and magnitude of peak displacement within the free AT. Quantifying internal tendon displacement patterns after ATR provides new insights into AT recovery.

Testing the proportional hazards assumption in cox regression and dealing with possible non-proportionality in total joint arthroplasty research: methodological perspectives and review.

BACKGROUND: Survival analysis and effect of covariates on survival time is a central research interest. Cox proportional hazards regression remains as a gold standard in the survival analysis. The Cox model relies on the assumption of proportional hazards (PH) across different covariates. PH assumptions should be assessed and handled if violated. Our aim was to investigate the reporting of the Cox regression model details and testing of the PH assumption in survival analysis in total joint arthroplasty (TJA) studies. METHODS: We conducted a review in the PubMed database on 28th August 2019. A total of 1154 studies were identified. The abstracts of these studies were screened for words "cox and "hazard*" and if either was found the abstract was read. The abstract had to fulfill the following criteria to be included in the full-text phase: topic was knee or hip TJA surgery; survival analysis was used, and hazard ratio reported. If all the presented criteria were met, the full-text version of the article was then read. The full-text was included if Cox method was used to analyze TJA survival. After accessing the full-texts 318 articles were included in final analysis. RESULTS: The PH assumption was mentioned in 114 of the included studies (36%). KM analysis was used in 281 (88%) studies and the KM curves were presented graphically in 243 of these (87%). In 110 (45%) studies, the KM survival curves crossed in at least one of the presented figures. The most common way to test the PH assumption was to inspect the log-minus-log plots (n = 59). The time-axis division method was the most used corrected model (n = 30) in cox analysis. Of the 318 included studies only 63 (20%) met the following criteria: PH assumption mentioned, PH assumption tested, testing method of the PH assumption named, the result of the testing mentioned, and the Cox regression model corrected, if required. CONCLUSIONS: Reporting and testing of the PH assumption and dealing with non-proportionality in hip and knee TJA studies was limited. More awareness and education regarding the assumptions behind the used statistical models among researchers, reviewers and editors are needed to improve the quality of TJA research. This could be achieved by better collaboration with methodologists and statisticians and introducing more specific reporting guidelines for TJA studies. Neglecting obvious non-proportionality undermines the overall research efforts since causes of non-proportionality, such as possible underlying pathomechanisms, are not considered and discussed.

Periprosthetic Femoral Fracture Is a Leading Cause of Early Revision With Taper-Slip Stems in Primary Total Hip Arthroplasty: An Analysis of 2765 Total Hip Arthroplasties From a High-Volume Hospital.

BACKGROUND: In 2016, the CPT stem replaced the Exeter stem as the main cemented stem at our institution. We assessed the prevalence of revision for periprosthetic femoral fracture (PFF) in patients operated on with either CPT or Exeter stem and compared the risk for revision between these stems. METHODS: Primary total hip arthroplasties either performed in 2012-2015 with Exeter stem (n = 1443) or in 2017-2018 with CPT stem (n = 1322) were included. The prevalence of revision for PFF was compared. The Kaplan-Meier estimated survivorships were calculated for the 2 stem designs. The risk for revision was analyzed using the Cox proportional hazard regression model. RESULTS: At 2 years, PFF was the most common reason for revision in the study population (1.3% prevalence, comprising 35% of all revisions). Moreover, 1.6% (95% confidence interval [CI] 1.0-2.4) of the CPT and 1.0% (95% CI 0.6-1.6) of the Exeter stems had been revised due to PFF. The 3-year Kaplan-Meier probability estimates for all-cause revision were 4.8% for the CPT (95% CI 3.6-6.0) and 3.3% for the Exeter stem (95% CI 2.3-4.3). The hazard ratio for revision due to any reason was 1.1 (95% CI 0.3-3.8) during the first 2 weeks, and 1.8 (95% CI 1.2-2.7, P = .006) from 2 weeks onwards for the CPT compared with the Exeter stem. CONCLUSION: The considerable number of PFF revisions with taper-slip stems, especially with CPT stems, is a matter of concern. Alternative cemented stems should be considered in patients at high risk for PFF.

Arthroscopic partial meniscectomy: did it ever work?

Arthroscopic partial meniscectomy (APM) is one the most common orthopedic surgical procedures. The most common indication for APM is a degenerative meniscal tear (DMT). High-quality evidence suggests that APM does not provide meaningful benefits in patients with DMTs and may even be harmful in the longer term. This narrative review focuses on a fundamental question: considering the history and large number of these surgeries, has APM ever actually worked in patients with DMT? A truly effective treatment needs a valid disease model that would biologically and plausibly explain the perceived treatment benefits. In the case of DMT, effectiveness requires a credible framework for the pain-generating process, which should be influenced by APM. Basic research, pathoanatomy, and clinical evidence gives no support to these frameworks. Moreover, treatment of DMT with an APM does not align with the traditional practice of medicine since DMT is not a reliable diagnosis for knee pain and no evidence-based indication exists that would influence patient prognosis from APM. A plausible and robust explanation supported by both basic research and clinical evidence is that DMTs are part of an osteoarthritic disease process and do not contribute to the symptoms independently or in isolation and that symptoms are not treatable with APM. This is further supported by the fact that APM as an intervention is paradoxical because the extent of procedure and severity of disease are both inversely associated with outcome. We argue that arthroscopic treatment of DMT is largely based on a logical fallacy: post hoc ergo propter hoc.

Implant survival of 662 dual-mobility cups and 727 constrained liners in primary THA: small femoral head size increases the cumulative incidence of revision.

Background and purpose - In total hip arthroplasty (THA), the risk for dislocation can be reduced using either dual-mobility cups (DMCs) or constrained liners (CLs). There are few studies comparing these concepts in primary THA. Therefore, we compared the cumulative incidence of revision in primary THA patients treated with DMC or CL with varying head sizes with conventional THA patients as reference group.Patients and methods - We performed a cohort study based on the Finnish arthroplasty register, comparing DMCs and CLs operated over the period 2000-2017. DMCs were divided into 2 groups based on the implant design: "DMC Trident" group (n = 399) and "DMC Others" group (n = 263). CLs were divided based on the femoral head size: "CL 36 mm" group (n = 425) and "CL < 36 mm" group (n = 302). All conventional primary THAs operated on in 2000-2017 with 28-36 mm femoral head were included as control group ("Conventional THA" group, n = 102,276). Implant survival was calculated by the corresponding cumulative incidence function with revision as the endpoint and death as competing event. Also, the prevalence of different reasons for revision was compared.Results - The 6-year cumulative incidence function estimates for the first revision were 6.9% (95% CI 4.0-9.7) for DMC Trident, 5.0% (CI 1.5-8.5) for DMC Others, 13% (CI 9.3-17) for CL < 36 mm, 6.3% (3.7-8.9) for CL 36 mm, and 4.7% (CI 4.5-4.8) for control group (conventional THA). The prevalence of dislocation revision was high (5.0%, CI 2.9-8.2) in the CL < 36 mm group compared with other groups.Interpretation - The DMC and CL 36 mm groups had promising mid-term survival rates, comparable to those of primary conventional THA group. The revision rate of CLs with < 36 mm head was high, mostly due to high prevalence of dislocation revisions. Therefore, CLs with 36 mm femoral head should be preferred over smaller ones.