Not all knees are the same.

The aim of mechanical alignment in total knee arthroplasty is to align all knees into a fixed neutral position, even though not all knees are the same. As a result, mechanical alignment often alters a patient's constitutional alignment and joint line obliquity, resulting in soft-tissue imbalance. This annotation provides an overview of how the Coronal Plane Alignment of the Knee (CPAK) classification can be used to predict imbalance with mechanical alignment, and then offers practical guidance for bone balancing, minimizing the need for soft-tissue releases.

Robotic-assisted burring in total hip replacement: A new surgical technique to optimise acetabular preparation.

BACKGROUND: In Total Hip replacement (THR) surgery, a critical step is to cut an accurate hemisphere into the acetabulum so that the component can be fitted accurately and obtain early stability. This study aims to determine whether burring rather than reaming the acetabulum can achieve greater accuracy in the creation of this hemisphere. METHODS: A preliminary robotic system was developed to demonstrate the feasibility of burring the acetabulum using the Universal Robot (UR10). The study will describe mechanical design, robot trajectory optimisation, control algorithm development, and results from phantom experiments compared with both robotic reaming and conventional reaming. The system was also tested in a cadaver experiment. RESULTS: The proposed robotic burring system can produce a surface in 2 min with an average error of 0.1 and 0.18 mm, when cutting polyurethane bone block #15 and #30, respectively. The performance was better than robotic reaming and conventional hand reaming. CONCLUSION: The proposed robotic burring system outperformed robotic and conventional reaming methods to produce an accurate acetabular cavity. The findings show the potential usage of a robotic-assisted burring in THR for acetabular preparation.

How often do we alter constitutional limb alignment, joint line obliquity, and Coronal Plane Alignment of the Knee (CPAK) phenotype when performing mechanically aligned TKA?

Aims: While mechanical alignment (MA) is the traditional technique in total knee arthroplasty (TKA), its potential for altering constitutional alignment remains poorly understood. This study aimed to quantify unintentional changes to constitutional coronal alignment and joint line obliquity (JLO) resulting from MA. Methods: A retrospective cohort study was undertaken of 700 primary MA TKAs (643 patients) performed between 2014 and 2017. Lateral distal femoral and medial proximal tibial angles were measured pre- and postoperatively to calculate the arithmetic hip-knee-ankle angle (aHKA), JLO, and Coronal Plane Alignment of the Knee (CPAK) phenotypes. The primary outcome was the magnitude and direction of aHKA, JLO, and CPAK alterations. Results: The mean aHKA and JLO increased by 0.1° (SD 3.4°) and 5.8° (SD 3.5°), respectively, from pre- to postoperatively. The most common phenotypes shifted from 76.3% CPAK Types I, II, or III (apex distal JLO) preoperatively to 85.0% IV, V, or VI (apex horizontal JLO) postoperatively. The proportion of knees with apex proximal JLO increased from 0.7% preoperatively to 11.1% postoperatively. Among all MA TKAs, 60.0% (420 knees) were changed from their constitutional alignments into CPAK Type V, while 40.0% (280 knees) either remained in constitutional Type V (5.0%, 35 knees) or were unintentionally aligned into other CPAK types (35.0%; 245 knees). Conclusion: Fixed MA targets in TKA lead to substantial changes from constitutional alignment, primarily a significant increase in JLO. These findings enhance our understanding of alignment alterations resulting from both unintended changes to knee phenotypes and surgical resection imprecision.

Functional alignment in total knee arthroplasty best achieves balanced gaps and minimal bone resections: an analysis comparing mechanical, kinematic and functional alignment strategies.

PURPOSE: Key concepts in total knee arthroplasty include restoration of limb alignment and soft-tissue balance. Although differences in balance have been reported amongst mechanical alignment (MA), kinematic alignment (KA) and functional alignment (FA) techniques, it remains unclear whether there are differences in gap imbalance or resection thicknesses when comparing different constitutional alignment subgroups. METHODS: MA (measured resection technique), KA (matched resections technique) and FA (technique based on the restricted KA boundaries) were compared in 116 consecutive patients undergoing 137 robotic-assisted cruciate-retaining total knee arthroplasties. The primary outcome was the proportion of balanced gaps (differential laxities ≤ 2 mm) for extension, flexion, medial and lateral gap measurements. Manual pre-resection laxity measurements were obtained for MA and KA and manual post-resection measurements were obtained for FA in 10° and in 90° of knee flexion. Secondary outcomes were resection depths and implant alignment. All outcomes were analysed per constitutional coronal alignment and joint line obliquity subgroups. RESULTS: The proportions of balance in all four gap measurements were 54.7%, 66.4% and 96.5%, with MA, KA and FA, respectively. Across all constitutional alignment types, FA achieved the highest proportion of balance. MA resected the least amount of bone from the medial tibial plateau. KA had femoral components in most valgus and most internally rotated, tibial components in most varus and was the most bone-preserving for the posteromedial femoral condyle. FA had the most externally rotated femoral components and was most bone-preserving for the distal femoral resections. CONCLUSION: The study shows that implant alignment to the mechanical axis or joint line anatomy (equal resections) alone does not guarantee a balanced total knee arthroplasty. FA resulted in the highest proportion of balanced knees across all analysed subgroups. Future research will consider whether one alignment philosophy leads to superior outcomes for different constitutional alignment subgroups. LEVEL OF EVIDENCE: Level II.

Effect of Physical Therapy vs Arthroscopic Partial Meniscectomy in People With Degenerative Meniscal Tears: Five-Year Follow-up of the ESCAPE Randomized Clinical Trial.

Importance: There is a paucity of high-quality evidence about the long-term effects (ie, 3-5 years and beyond) of arthroscopic partial meniscectomy vs exercise-based physical therapy for patients with degenerative meniscal tears. Objectives: To compare the 5-year effectiveness of arthroscopic partial meniscectomy and exercise-based physical therapy on patient-reported knee function and progression of knee osteoarthritis in patients with a degenerative meniscal tear. Design, Setting, and Participants: A noninferiority, multicenter randomized clinical trial was conducted in the orthopedic departments of 9 hospitals in the Netherlands. A total of 321 patients aged 45 to 70 years with a degenerative meniscal tear participated. Data collection took place between July 12, 2013, and December 4, 2020. Interventions: Patients were randomly allocated to arthroscopic partial meniscectomy or 16 sessions of exercise-based physical therapy. Main Outcomes and Measures: The primary outcome was patient-reported knee function (International Knee Documentation Committee Subjective Knee Form (range, 0 [worst] to 100 [best]) during 5 years of follow-up based on the intention-to-treat principle, with a noninferiority threshold of 11 points. The secondary outcome was progression in knee osteoarthritis shown on radiographic images in both treatment groups. Results: Of 321 patients (mean [SD] age, 58 [6.6] years; 161 women [50.2%]), 278 patients (87.1%) completed the 5-year follow-up with a mean follow-up time of 61.8 months (range, 58.8-69.5 months). From baseline to 5-year follow-up, the mean (SD) improvement was 29.6 (18.7) points in the surgery group and 25.1 (17.8) points in the physical therapy group. The crude between-group difference was 3.5 points (95% CI, 0.7-6.3 points; P < .001 for noninferiority). The 95% CI did not exceed the noninferiority threshold of 11 points. Comparable rates of progression of radiographic-demonstrated knee osteoarthritis were noted between both treatments. Conclusions and Relevance: In this noninferiority randomized clinical trial after 5 years, exercise-based physical therapy remained noninferior to arthroscopic partial meniscectomy for patient-reported knee function. Physical therapy should therefore be the preferred treatment over surgery for degenerative meniscal tears. These results can assist in the development and updating of current guideline recommendations about treatment for patients with a degenerative meniscal tear. Trial Registration: ClinicalTrials.gov Identifier: NCT01850719.

An individualized decision between physical therapy or surgery for patients with degenerative meniscal tears cannot be based on continuous treatment selection markers: a marker-by-treatment analysis of the ESCAPE study.

PURPOSE: Marker-by-treatment analyses are promising new methods in internal medicine, but have not yet been implemented in orthopaedics. With this analysis, specific cut-off points may be obtained, that can potentially identify whether meniscal surgery or physical therapy is the superior intervention for an individual patient. This study aimed to introduce a novel approach in orthopaedic research to identify relevant treatment selection markers that affect treatment outcome following meniscal surgery or physical therapy in patients with degenerative meniscal tears. METHODS: Data were analysed from the ESCAPE trial, which assessed the treatment of patients over 45 years old with a degenerative meniscal tear. The treatment outcome of interest was a clinically relevant improvement on the International Knee Documentation Committee Subjective Knee Form at 3, 12, and 24 months follow-up. Logistic regression models were developed to predict the outcome using baseline characteristics (markers), the treatment (meniscal surgery or physical therapy), and a marker-by-treatment interaction term. Interactions with p < 0.10 were considered as potential treatment selection markers and used these to develop predictiveness curves which provide thresholds to identify marker-based differences in clinical outcomes between the two treatments. RESULTS: Potential treatment selection markers included general physical health, pain during activities, knee function, BMI, and age. While some marker-based thresholds could be identified at 3, 12, and 24 months follow-up, none of the baseline characteristics were consistent markers at all three follow-up times. CONCLUSION: This novel in-depth analysis did not result in clear clinical subgroups of patients who are substantially more likely to benefit from either surgery or physical therapy. However, this study may serve as an exemplar for other orthopaedic trials to investigate the heterogeneity in treatment effect. It will help clinicians to quantify the additional benefit of one treatment over another at an individual level, based on the patient's baseline characteristics. LEVEL OF EVIDENCE: II.

Digital medical history implementation to triage orthopaedic patients during COVID-19: Findings from a rapid cycle, semi-randomised A/B testing quality improvement project.

INTRODUCTION: The COVID-19 pandemic severely impacted musculoskeletal care. To better triage the notable backlog of patients, we assessed whether a digital medical history (DMH), a summary of health information and concerns completed by the patient prior to a clinic visit, could be routinely collected and utilised. METHODS: We analysed 640 patients using a rapid cycle, semi-randomised A/B testing approach. Four rapid cycles of different randomised interventions were conducted across five unique patient groups. Descriptive statistics were used to report DMH completion rates by cycle/patient group and intervention. Multivariable logistic regression was used to determine whether age or anatomic injury location was associated DMH completion. ETHICAL APPROVAL: N/A (Quality Improvement Project) RESULTS: Across all patients, the DMH completion rate was 48% (307/640). Phone calls were time consuming and resource intensive without an increased completion rate. The highest rate of DMH completion was among patients who were referred and called the clinic themselves (78% of patients [63 out of 81 patients]). Across all patients, increasing age (odds ratio [OR]: 0.985 (95% CI: 0.976-0.995), p = 0.002), patients with back concerns (OR: 0.395 (95% CI: 0.234-0.666), p = 0.001), and patients with non-specific/other musculoskeletal concerns (OR: 0.331 (95% CI: 0.176-0.623), p = 0.001) were associated with decreased odds of DMH completion. DISCUSSION AND CONCLUSION: DMHs can be valuable in helping triage orthopaedic patients in resource-strapped settings, times of crisis, or as we transition towards value-based health care delivery. However, further work is needed to continue to increase the completion rate about 50%.

Is There An Association Between Bundled Payments and "Cherry Picking" and "Lemon Dropping" in Orthopaedic Surgery? A Systematic Review.

BACKGROUND: The goal of bundled payments-lump monetary sums designed to cover the full set of services needed to provide care for a condition or medical event-is to provide a reimbursement structure that incentivizes improved value for patients. There is concern that such a payment mechanism may lead to patient screening and denying or providing orthopaedic care to patients based on the number and severity of comorbid conditions present associated with complications after surgery. Currently, however, there is no clear consensus about whether such an association exists. QUESTIONS/PURPOSES: In this systematic review, we asked: (1) Is the implementation of a bundled payment model associated with a change in the sociodemographic characteristics of patients undergoing an orthopaedic procedure? (2) Is the implementation of a bundled payment model associated with a change in the comorbidities and/or case-complexity characteristics of patients undergoing an orthopaedic procedure? (3) Is the implementation of a bundled payment model associated with a change in the recent use of healthcare resources characteristics of patients undergoing an orthopaedic procedure? METHODS: This systematic review was registered in PROSPERO before data collection (CRD42020189416). Our systematic review included scientific manuscripts published in MEDLINE, Embase, Web of Science, Econlit, Policyfile, and Google Scholar through March 2020. Of the 30 studies undergoing full-text review, 20 were excluded because they did not evaluate the outcome of interest (patient selection) (n = 8); were editorial, commentary, or review articles (n = 5); did not evaluate the appropriate intervention (introduction of a bundled payment program) (n = 4); or assessed the wrong patient population (not orthopaedic surgery patients) (n = 3). This led to 10 studies included in this systematic review. For each study, patient factors analyzed in the included studies were grouped into the following three categories: sociodemographics, comorbidities and/or case complexity, or recent use of healthcare resources characteristics. Next, each patient factor falling into one of these three categories was examined to evaluate for changes from before to after implementation of a bundled payment initiative. In most cases, studies utilized a difference-in-difference (DID) statistical technique to assess for changes. Determination of whether the bundled payment initiative required mandatory participation or not was also noted. Scientific quality using the Adapted Newcastle-Ottawa Scale had a median (range) score of 8 (7 to 8; highest possible score: 9), and the quality of the total body of evidence for each patient characteristic group was found to be low using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) tool. We could not assess the likelihood of publication using funnel plots because of the variation of patient factors analyzed in each study and the heterogeneity of data precluded a meta-analysis. RESULTS: Of the nine included studies that reported on the sociodemographic characteristics of patients selected for care, seven showed no change with the implementation of bundled payments, and two demonstrated a difference. Most notably, the studies identified a decrease in the percentage of patients undergoing an orthopaedic operative intervention who were dual-eligible (range DID estimate -0.4% [95% CI -0.75% to -0.1%]; p < 0.05 to DID estimate -1.0% [95% CI -1.7% to -0.2%]; p = 0.01), which means they qualified for both Medicare and Medicaid insurance coverage. Of the 10 included studies that reported on comorbidities and case-complexity characteristics, six reported no change in such characteristics with the implementation of bundled payments, and four studies noted differences. Most notably, one study showed a decrease in the number of treated patients with disabilities (DID estimate -0.6% [95% CI -0.97% to -0.18%]; p < 0.05) compared with before bundled payment implementation, while another demonstrated a lower number of Elixhauser comorbidities for those treated as part of a bundled payment program (before: score of 0-1 in 63.6%, 2-3 in 27.9%, > 3 in 8.5% versus after: score of 0-1 in 50.1%, 2-3 in 38.7%, > 3 in 11.2%; p = 0.033). Of the three included studies that reported on the recent use of healthcare resources of patients, one study found no difference in the use of healthcare resources with the implementation of bundled payments, and two studies did find differences. Both studies found a decrease in patients undergoing operative management who recently received care at a skilled nursing facility (range DID estimate -0.50% [95% CI -1.0% to 0.0%]; p = 0.04 to DID estimate: -0.53% [95% CI -0.96% to -0.10%]; p = 0.01), while one of the studies also found a decrease in patients undergoing operative management who recently received care at an acute care hospital (DID estimate -0.8% [95% CI -1.6% to -0.1%]; p = 0.03) or as part of home healthcare (DID estimate -1.3% [95% CI -2.0% to -0.6%]; p < 0.001). CONCLUSION: In six of 10 studies in which differences in patient characteristics were detected among those undergoing operative orthopaedic intervention once a bundled payment program was initiated, the effect was found to be minimal (approximately 1% or less). However, our findings still suggest some level of adverse patient selection, potentially worsening health inequities when considered on a large scale. It is also possible that our findings reflect better care, whereby the financial incentives lead to fewer patients with a high risk of complications undergoing surgical intervention and vice versa for patients with a low risk of complications postoperatively. However, this is a fine line, and it may also be that patients with a high risk of complications postoperatively are not being offered surgery enough, while patients at low risk of complications postoperatively are being offered surgery too frequently. Evaluation of the longer-term effect of these preliminary bundled payment programs on patient selection is warranted to determine whether adverse patient selection changes over time as health systems and orthopaedic surgeons become accustomed to such reimbursement models.

Functional Outcomes of Arthroscopic Partial Meniscectomy Versus Physical Therapy for Degenerative Meniscal Tears Using a Patient-Specific Score: A Randomized Controlled Trial.

BACKGROUND: It is unknown whether the treatment effects of partial meniscectomy and physical therapy differ when focusing on activities most valued by patients with degenerative meniscal tears. PURPOSE: To compare partial meniscectomy with physical therapy in patients with a degenerative meniscal tear, focusing on patients' most important functional limitations as the outcome. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: This study is part of the Cost-effectiveness of Early Surgery versus Conservative Treatment with Optional Delayed Meniscectomy for Patients over 45 years with non-obstructive meniscal tears (ESCAPE) trial, a multicenter noninferiority randomized controlled trial conducted in 9 orthopaedic hospital departments in the Netherlands. The ESCAPE trial included 321 patients aged between 45 and 70 years with a symptomatic, magnetic resonance imaging-confirmed meniscal tear. Exclusion criteria were severe osteoarthritis, body mass index >35 kg/m2, locking of the knee, and prior knee surgery or knee instability due to an anterior or posterior cruciate ligament rupture. This study compared partial meniscectomy with physical therapy consisting of a supervised incremental exercise protocol of 16 sessions over 8 weeks. The main outcome measure was the Dutch-language equivalent of the Patient-Specific Functional Scale (PSFS), a secondary outcome measure of the ESCAPE trial. We used crude and adjusted linear mixed-model analyses to reveal the between-group differences over 24 months. We calculated the minimal important change for the PSFS using an anchor-based method. RESULTS: After 24 months, 286 patients completed the follow-up. The partial meniscectomy group (n = 139) improved on the PSFS by a mean of 4.8 ± 2.6 points (from 6.8 ± 1.9 to 2.0 ± 2.2), and the physical therapy group (n = 147) improved by a mean of 4.0 ± 3.1 points (from 6.7 ± 2.0 to 2.7 ± 2.5). The crude overall between-group difference showed a -0.6-point difference (95% CI, -1.0 to -0.2; P = .004) in favor of the partial meniscectomy group. This improvement was statistically significant but not clinically meaningful, as the calculated minimal important change was 2.5 points on an 11-point scale. CONCLUSION: Both interventions were associated with a clinically meaningful improvement regarding patients' most important functional limitations. Although partial meniscectomy was associated with a statistically larger improvement at some follow-up time points, the difference compared with physical therapy was small and clinically not meaningful at any follow-up time point. REGISTRATION: NCT01850719 (ClinicalTrials.gov identifier) and NTR3908 (the Netherlands Trial Register).

Arthroscopic meniscectomy versus non-surgical or sham treatment in patients with MRI confirmed degenerative meniscus lesions: a protocol for an individual participant data meta-analysis.

INTRODUCTION: Arthroscopic partial meniscectomy (APM) after degenerative meniscus tears is one of the most frequently performed surgeries in orthopaedics. Although several randomised controlled trials (RCTs) have been published that showed no clear benefit compared with sham treatment or non-surgical treatment, the incidence of APM remains high. The common perception by most orthopaedic surgeons is that there are subgroups of patients that do need APM to improve, and they argue that each study sample of the existing trials is not representative for the day-to-day patients in the clinic. Therefore, the objective of this individual participant data meta-analysis (IPDMA) is to assess whether there are subgroups of patients with degenerative meniscus lesions who benefit from APM in comparison with non-surgical or sham treatment. METHODS AND ANALYSIS: An existing systematic review will be updated to identify all RCTs worldwide that evaluated APM compared with sham treatment or non-surgical treatment in patients with knee symptoms and degenerative meniscus tears. Time and effort will be spent in contacting principal investigators of the original trials and encourage them to collaborate in this project by sharing their trial data. All individual participant data will be validated for missing data, internal data consistency, randomisation integrity and censoring patterns. After validation, all datasets will be combined and analysed using a one-staged and two-staged approach. The RCTs' characteristics will be used for the assessment of clinical homogeneity and generalisability of the findings. The most important outcome will be the difference between APM and control groups in knee pain, function and quality of life 2 years after the intervention. Other outcomes of interest will include the difference in adverse events and mental health. ETHICS AND DISSEMINATION: All trial data will be anonymised before it is shared with the authors. The data will be encrypted and stored on a secure server located in the Netherlands. No major ethical concerns remain. This IPDMA will provide the evidence base to update and tailor diagnostic and treatment protocols as well as (international) guidelines for patients for whom orthopaedic surgeons consider APM. The results will be submitted for publication in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42017067240.

How do the costs of physical therapy and arthroscopic partial meniscectomy compare? A trial-based economic evaluation of two treatments in patients with meniscal tears alongside the ESCAPE study.

OBJECTIVES: To examine whether physical therapy (PT) is cost-effective compared with arthroscopic partial meniscectomy (APM) in patients with a non-obstructive meniscal tear, we performed a full trial-based economic evaluation from a societal perspective. In a secondary analysis-this paper-we examined whether PT is non-inferior to APM. METHODS: We recruited patients aged 45-70 years with a non-obstructive meniscal tear in nine Dutch hospitals. Resource use was measured using web-based questionnaires. Measures of effectiveness included knee function using the International Knee Documentation Committee (IKDC) and quality-adjusted life-years (QALYs). Follow-up was 24 months. Uncertainty was assessed using bootstrapping techniques. The non-inferiority margins for societal costs, the IKDC and QALYs, were €670, 8 points and 0.057 points, respectively. RESULTS: We randomly assigned 321 patients to PT (n=162) or APM (n=159). PT was associated with significantly lower costs after 24 months compared with APM (-€1803; 95% CI -€3008 to -€838). The probability of PT being cost-effective compared with APM was 1.00 at a willingness to pay of €0/unit of effect for the IKDC (knee function) and QALYs (quality of life) and decreased with increasing values of willingness to pay. The probability that PT is non-inferior to APM was 0.97 for all non-inferiority margins for the IKDC and 0.89 for QALYs. CONCLUSIONS: The probability of PT being cost-effective compared with APM was relatively high at reasonable values of willingness to pay for the IKDC and QALYs. Also, PT had a relatively high probability of being non-inferior to APM for both outcomes. This warrants further deimplementation of APM in patients with non-obstructive meniscal tears. TRIAL REGISTRATION NUMBERS: NCT01850719 and NTR3908.

Can even experienced orthopaedic surgeons predict who will benefit from surgery when patients present with degenerative meniscal tears? A survey of 194 orthopaedic surgeons who made 3880 predictions.

OBJECTIVES: To examine the ability of surgeons to predict the outcome of treatment for meniscal tears by arthroscopic partial meniscectomy (APM) and exercise therapy in middle-aged patients. DESIGN AND SETTING: Electronic survey. Orthopaedic surgeon survey participants were presented 20 patient profiles. These profiles were derived from a randomised clinical trial comparing APM with exercise therapy in middle-aged patients with symptomatic non-obstructive meniscal tears. From each treatment group (APM and exercise therapy), we selected five patients with the best (responders) and five patients with the worst (non-responders) knee function after treatment. 1111 orthopaedic surgeons and residents in the Netherlands and Australia were invited to participate in the survey. INTERVENTIONS: For each of the 20 patient profiles, surgeons (unaware of treatment allocation) had to choose between APM and exercise therapy as preferred treatment and subsequently had to estimate the expected change in knee function for both treatments on a 5-point Likert Scale. Finally, surgeons were asked which patient characteristics affected their treatment choice. MAIN OUTCOMES: The primary outcome was the surgeons' percentage correct predictions. We also compared this percentage between experienced knee surgeons and other orthopaedic surgeons, and between treatment responders and non-responders. RESULTS: We received 194 (17%) complete responses for all 20 patient profiles, resulting in 3880 predictions. Overall, 50.0% (95% CI 39.6% to 60.4%) of the predictions were correct, which equals the proportion expected by chance. Experienced knee surgeons were not better in predicting outcome than other orthopaedic surgeons (50.4% vs 49.5%, respectively; p=0.29). The percentage correct predictions was lower for patient profiles of non-responders (34%; 95% CI 21.3% to 46.6%) compared with responders (66.0%; 95% CI 57.0% to 75.0%; p=0.01).In general, bucket handle tears, knee locking and failed non-operative treatment directed the surgeons' choice towards APM, while higher level of osteoarthritis, degenerative aetiology and the absence of locking complaints directed the surgeons' choice towards exercise therapy. CONCLUSIONS: Surgeons' criteria for deciding that surgery was indicated did not pass statistical examination. This was true regardless of a surgeon's experience. These results suggest that non-surgical management is appropriate as first-line therapy in middle-aged patients with symptomatic non-obstructive meniscal tears. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03462134.

Responsiveness and Minimal Important Change of the IKDC of Middle-Aged and Older Patients With a Meniscal Tear.

BACKGROUND: Responsiveness and the minimal important change (MIC) are important measurement properties to evaluate treatment effects and to interpret clinical trial results. The International Knee Documentation Committee (IKDC) Subjective Knee Form is a reliable and valid instrument for measuring patient-reported knee-specific symptoms, functioning, and sports activities in a population with meniscal tears. However, evidence on responsiveness is of limited methodological quality, and the MIC has not yet been established for patients with symptomatic meniscal tears. PURPOSE: To evaluate the responsiveness and determine the MIC of the IKDC for patients with meniscal tears. STUDY DESIGN: Cohort study (design); Level of evidence 2. METHODS: This study was part of the ESCAPE trial: a noninferiority multicenter randomized controlled trial comparing arthroscopic partial meniscectomy with physical therapy. Patients aged 45 to 70 years who were treated for a meniscal tear by arthroscopic partial meniscectomy or physical therapy completed the IKDC and 3 other questionnaires (RAND 36-Item Health Survey, EuroQol-5D-5L, and visual analog scales for pain) at baseline and 6-month follow-up. Responsiveness was evaluated by testing predefined hypotheses about the relation of the change in IKDC with regard to the change in the other self-reported outcomes. An external anchor question was used to distinguish patients reporting improvement versus no change in daily functioning. The MIC was determined by the optimal cutoff point in the receiver operating characteristic curve, which quantifies the IKDC score that best discriminated between patients with and without improvement in daily function. RESULTS: Data from all 298 patients who completed baseline and 6-month follow-up questionnaires were analyzed. Responsiveness of the IKDC was confirmed in 7 of 10 predefined hypotheses about the change in IKDC score with regard to other patient-reported outcome measures. One hypothesis differed in the expected direction, while 2 hypotheses failed to meet the expected magnitude by 0.02 and 0.01 points. An MIC of 10.9 points was calculated for the IKDC of middle-aged and older patients with meniscal tears. CONCLUSION: This study showed that the IKDC is responsive to change among patients aged 45 to 70 years with meniscal tears, with an MIC of 10.9 points. This strengthens the value of the IKDC in quantifying treatment effects in this population.

Effect of Early Surgery vs Physical Therapy on Knee Function Among Patients With Nonobstructive Meniscal Tears: The ESCAPE Randomized Clinical Trial.

Importance: Despite recent studies suggesting arthroscopic partial meniscectomy (APM) is not more effective than physical therapy (PT), the procedure is still frequently performed in patients with meniscal tears. Objective: To assess whether PT is noninferior to APM for improving patient-reported knee function in patients with meniscal tears. Design, Setting, and Participants: Noninferiority, multicenter, randomized clinical trial conducted in 9 hospitals in the Netherlands. Participants were aged 45 to 70 years with nonobstructive meniscal tears (ie, no locking of the knee joint). Patients with knee instability, severe osteoarthritis, and body mass index greater than 35 were excluded. Recruitment took place between July 17, 2013, and November 4, 2015. Participants were followed up for 24 months (final participant follow-up, October 11, 2017). Interventions: Three hundred twenty-one participants were randomly assigned to APM (n = 159) or a predefined PT protocol (n = 162). The PT protocol consisted of 16 sessions of exercise therapy over 8 weeks focused on coordination and closed kinetic chain strength exercises. Main Outcomes and Measures: The primary outcome was change in patient-reported knee function on the International Knee Documentation Committee Subjective Knee Form (range, 0 to 100; from worse to best) from baseline over a 24-month follow-up period. The noninferiority margin was defined as a difference between treatment groups of 8 points and was assessed with a 1-sided α of .025. The primary analysis followed the intention-to-treat principle. Results: Among 321 patients who were randomized (mean [SD] age, 58 [6.6] years; 161 women [50%]), 289 (90%) completed the trial (161 women and 158 men). In the PT group, 47 participants (29%) had APM during the 24-month follow-up period, and 8 participants randomized to APM (5%) did not have APM. Over a 24-month follow-up period, knee function improved in the APM group by 26.2 points (from 44.8 to 71.5) and in the PT group by 20.4 points (from 46.5 to 67.7). The overall between-group difference was 3.6 points (97.5% CI, -∞ to 6.5; P value for noninferiority = .001). Adverse events occurred in 18 participants in the APM group and 12 in the PT group. Repeat surgery (3 in the APM group and 1 in the PT group) and additional outpatient visits for knee pain (6 in the APM group and 2 in the PT group) were the most frequent adverse events. Conclusions and Relevance: Among patients with nonobstructive meniscal tears, PT was noninferior to APM for improving patient-reported knee function over a 24-month follow-up period. Based on these results, PT may be considered an alternative to surgery for patients with nonobstructive meniscal tears. Trial Registration: ClinicalTrials.gov Identifier: NCT01850719.

Cost-effectiveness of Early Surgery versus Conservative Treatment with Optional Delayed Meniscectomy for Patients over 45†years with non-obstructive meniscal tears (ESCAPE study): protocol of a randomised controlled trial.

INTRODUCTION: Recent studies show similar outcome between surgery and conservative treatment in patients with non-obstructive meniscal tears. However, surgery is still often preferred over conservative treatment. When conservative treatment is non-inferior to surgery, shifting the current standard treatment choice to conservative treatment alone could save over €30 millions of direct medical costs on an annual basis. Economic evaluation studies comparing surgery to conservative treatment are lacking. METHODS AND ANALYSIS: A multicentre randomised controlled trial (RCT) with an economic evaluation alongside was performed to assess the (cost)-effectiveness of surgery and conservative treatment for meniscal tears. We will include 402 participants between 45 and 70 years with an MRI-confirmed symptomatic, non-obstructive meniscal tears to prove non-inferiority of conservative treatment. Block randomisation will be web-based. The primary outcome measure is a physical function, measured by the International Knee Documentation Committee 'Subjective Knee Form'. Furthermore, we will perform a cost-effectiveness and cost-utility analysis from societal perspective and a budget impact analysis from a societal, government and insurer perspective. Secondary outcomes include general health, quality of life, activity level, knee pain, physical examination, progression of osteoarthritis and the occurrence of adverse events. ETHICS AND DISSEMINATION: This RCT will be performed in accordance with the Declaration of Helsinki and has been approved by the Ethics Committee (number NL44188.100.13). The results of this study will be reported in peer-reviewed journals and at international conferences. We further aim to disseminate our results to guideline committees. TRIAL REGISTRATION NUMBER: NCT01850719.

Arthroscopic Partial Meniscectomy or Conservative Treatment for Nonobstructive Meniscal Tears: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

PURPOSE: To conduct a meta-analysis of randomized controlled trials comparing the outcome of arthroscopic partial meniscectomy (APM) with conservative treatment in adults with nonobstructive meniscal tears and to recommend a treatment of choice. METHODS: We systematically searched the databases of MEDLINE, Excerpta Medica Database, Cochrane, the National Health Service Centre for Reviews and Dissemination, and Physiotherapy Evidence Database from inception to May 2, 2016. Two authors independently searched the literature and selected eligible studies. The meta-analyses used a random-effects model. The primary outcome was physical function, measured by knee-specific patient-reported outcomes. Secondary outcomes included knee pain, activity level, the progression of osteoarthritis, adverse events, general health, and quality of life. RESULTS: We included 6 randomized controlled trials, with a total of 773 patients, of whom 378 were randomized to APM and 395 were randomized to the control treatment. After pooling the data of 5 studies, we found small significant differences in favor of the APM group for physical function at 2 to 3 months (mean difference [MD] = 3.31; 95% confidence interval [CI] = 0.69-5.93; P = .01; I(2) = 0% [Lysholm knee score]), and at 6 months (MD = 3.56; 95% CI = 0.24-6.88; P = .04; I(2) = 0% (Knee injury and Osteoarthritis Outcome Score [KOOS] and Western Ontario and McMaster Universities Osteoarthritis Index); standardized MD = 0.17; 95% CI = 0.01-0.32; P = .03; I(2) = 0% [Lysholm knee score, KOOS, and Western Ontario and McMaster Universities Osteoarthritis Index]). We also found small significant differences for pain at 6 months (MD = 3.56; 95% CI = 0.18-6.95; P = .04; I(2) = 0% [KOOS] and MD = 0.56; 95% CI = 0.28-0.83; P ≤ .0001; I(2) = 0% [visual analog scale and numeric rating scale]). We found no significant differences after 12 and 24 months. CONCLUSIONS: We found small, although statistically significant, favorable results of APM up to 6 months for physical function and pain. However, we found no differences at longer follow-up. LEVEL OF EVIDENCE: Level I, systematic review and meta-analysis of Level I studies.

Surgical interventions for meniscal tears: a closer look at the evidence.

INTRODUCTION: The aim of the present study was to compare the outcomes of various surgical treatments for meniscal injuries including (1) total and partial meniscectomy; (2) meniscectomy and meniscal repair; (3) meniscectomy and meniscal transplantation; (4) open and arthroscopic meniscectomy and (5) various different repair techniques. MATERIALS AND METHODS: The Bone, Joint and Muscle Trauma Group Register, Cochrane Database, MEDLINE, EMBASE and CINAHL were searched for all (quasi) randomized controlled clinical trials comparing various surgical techniques for meniscal injuries. Primary outcomes of interest included patient-reported outcomes scores, return to pre-injury activity level, level of sports participation and persistence of pain using the visual analogue score. Where possible, data were pooled and a meta-analysis was performed. RESULTS: A total of nine studies were included, involving a combined 904 subjects, 330 patients underwent a meniscal repair, 402 meniscectomy and 160 a collagen meniscal implant. The only surgical treatments that were compared in homogeneous fashion across more than one study were the arrow and inside-out technique, which showed no difference for re-tear or complication rate. Strong evidence-based recommendations regarding the other surgical treatments that were compared could not be made. CONCLUSIONS: This meta-analysis illustrates the lack of level I evidence to guide the surgical management of meniscal tears. LEVEL OF EVIDENCE: Level I meta-analysis.

Reliability and Validity of the IKDC, KOOS, and WOMAC for Patients With Meniscal Injuries.

BACKGROUND: Several patient-reported outcome measurements are used to measure functional outcome after treatment of meniscal injuries. However, for comparison of study results, there is a need for a uniform and standardized approach of measuring functional outcome. Selection of the instrument should be based on the quality of its measurement properties, and only the best instrument can be justified to be used. PURPOSE: This study aimed to determine and compare the measurement properties of the Dutch-language versions of the International Knee Documentation Committee (IKDC) Subjective Knee Form, Knee Injury and Osteoarthritis Outcome Score (KOOS), and Western Ontario and McMaster Universities Arthritis Index (WOMAC) in a homogeneous group of patients with meniscal tears. STUDY DESIGN: Cohort study (design); Level of evidence, 2. METHODS: Patients on the waiting list for meniscal surgery and patients between 6 weeks and 6 months after meniscal surgery were included (n = 75). Patients were excluded if they received an arthroplasty or had surgery on the anterior cruciate ligament. Internal consistency (Cronbach alpha), test-retest reliability (intraclass correlation coefficient [ICC]), measurement error (SEM), smallest detectable difference (SDD), content validity, construct validity (factor analysis and hypothesis testing), and floor and ceiling effects were determined. RESULTS: Results for the IKDC, KOOS dimensions, and WOMAC dimensions, respectively, were as follows: Cronbach alpha = .90, .72-.95, and .84-.95; ICC = 0.93, 0.84-0.89, and 0.77-0.89; SEM = 5.3, 7.0-12.6, and 7.3-12.2; SDD = 14.6, 19.4-35.0, and 20.2-33.9; hypotheses testing confirmation = 100%, 86%, and 85%. Floor effects within the SDD from the minimum score were found for the KOOS Sports/Recreation and Quality of Life dimensions. Ceiling effects within the SDD from the maximum score were found for the KOOS Activities of Daily Living and for all WOMAC dimensions. CONCLUSION: The IKDC showed the best performance on all measurement properties, implying that the IKDC, rather than the KOOS or WOMAC, should be used to assess functional outcome in patients with meniscal tears.