A systematic review of randomized control trials looking at functional improvement of rotator cuff partial thickness tears following platelet-rich-plasma injection: a comparison of glenohumeral joint vs. subacromial bursa vs. intratendinous injection locations.

Background: Prior research has demonstrated that platelet-rich plasma (PRP) has shown promising results in the treatment of knee osteoarthritis, lateral epicondylitis, and rotator cuff disease. However, there is a lack of standardization with PRP regarding its use for partial thickness rotator cuff tears (PTRCTs). The primary objective of this review is to assess the location of PRP injections in the shoulder, and how it corresponds to shoulder functional outcomes in PTRCTs. Methods: Data sources included randomized controlled trials (RCTs) conducted between January 2010 and September 2021 with the terms PRP, partial thickness rotator cuff tears, intra-articular injections, subacromial injections, and intratendinous injections. Major inclusion criteria: partial thickness rotator cuff tears only, functional outcome scores pre-injection and post-injection, minimum 2-month follow-up time, and nonsurgical PRP injections only. Major exclusion criteria: PRP used as an adjunct therapy, full-thickness rotator cuff tears, and surgical intervention before treatment. Results: A total of 8 RCTs were included which utilized PRP injected into the shoulder for PTRCTs. Studies were grouped by the location of the injection with the following breakdown: 1 glenohumeral joint, 4 subacromial bursa, and 3 intratendinous as the site of injection of PRP. Intra-articular PRP showed a 46.2% improvement (P < .05) in the Disabilities of the Arm, Shoulder, and Hand score at 12-month follow-up, however PRP compared to physical therapy had no statistical difference. For subacromial injections, one study showed no statistical difference between hyaluronic acid and PRP vs PRP, but both groups showed improvement compared to normal saline at 3, 6, and 12 months (P < .05). For intratendinous injections, PRP was found to be superior in the Shoulder Pain and Disability Index scores at 66.1% improvement (P < .05) at 3 months and 71.6% at 6 months (P < .05) after two PRP injections when compared to dry needling. Another study showed a statistically significant difference in ASES score when combining LP-PRP injection intratendinous and subacromial bursa when compared to corticosteroid at 3 months. Furthermore, at 6-month follow-up, the PRP group showed significant improvement in the Oxford Shoulder Score compared to a subacromial bursa corticosteroid group 53.8% vs 31.7% (P < .01). Conclusion: Based on our review of current literature, there is inconclusive evidence of the ideal location to inject PRP when partial rotator cuff tear is present. Despite PRP showing improved functional outcomes in patients diagnosed with PTRCT regardless of the injection site, more research is needed to figure out the optimal concentration of PRP, frequency of injection, and who are ideal candidates when utilizing PRP for PTRCTs.

Surgeon Performance as a Predictor for Patient-Reported Outcomes After Arthroscopic Partial Meniscectomy.

Background: Surgeon performance has been investigated as a factor affecting patient outcomes after orthopaedic procedures to improve transparency between patients and providers. Purpose/Hypothesis: The purpose of this study was to identify whether surgeon performance influenced patient-reported outcomes (PROMs) 1 year after arthroscopic partial meniscectomy (APM). It was hypothesized that there would be no significant difference in PROMs between patients who underwent APM from various surgeons. Study Design: Case-control study; Level of evidence, 3. Methods: A prospective cohort of 794 patients who underwent APM between 2018 and 2019 were included in the analysis. A total of 34 surgeons from a large multicenter health care center were included. Three multivariable models were built to determine whether the surgeon-among demographic and meniscal pathology factors-was a significant variable for predicting the Knee injury and Osteoarthritis Outcome Score (KOOS)-Pain subscale, the Patient Acceptable Symptom State (PASS), and a 10-point improvement in the KOOS-Pain at 1 year after APM. Likelihood ratio (LR) tests were used to determine the significance of the surgeon variable in the models. Results: The 794 patients were identified from the multicenter hospital system. The baseline KOOS-Pain score was a significant predictor of outcome in the 1-year KOOS-Pain model (odds ratio [OR], 2.1 [95% CI, 1.77-2.48]; P < .001), the KOOS-Pain 10-point improvement model (OR, 0.57 [95% CI, 0.44-0.73), and the 1-year PASS model (OR, 1.42 [95% CI, 1.15-1.76]; P = .002) among articular cartilage pathology (bipolar medial cartilage) and patient-factor variables, including body mass index, Veterans RAND 12-Item Health Survey-Mental Component Score, and Area Deprivation Index. The individual surgeon significantly impacted outcomes in the 1-year KOOS-Pain mixed model in the LR test (P = .004). Conclusion: Patient factors and characteristics are better predictors for patient outcomes 1 year after APM than surgeon characteristics, specifically baseline KOOS-Pain, although an individual surgeon influenced the 1-Year KOOS-Pain mixed model in the LR test. This finding has key clinical implications; surgeons who wish to improve patient outcomes after APM should focus on improving patient selection rather than improving the surgical technique. Future research is needed to determine whether surgeon variability has an impact on longer-term patient outcomes.

The Psychology of ACL Injury, Treatment, and Recovery: Current Concepts and Future Directions.

CONTEXT: Interest in the relationship between psychology and the outcomes of anterior cruciate ligament (ACL) reconstruction (ACLR) continues to grow as variable rates of return to preinjury level of activity continue to be observed. EVIDENCE ACQUISITION: Articles were collected from peer-reviewed sources available on PubMed using a combination of search terms, including psychology, resilience, mental health, recovery, and anterior cruciate ligament reconstruction. Further evaluation of the included bibliographies were used to expand the evidence. STUDY DESIGN: Clinical review. LEVEL OF EVIDENCE: Level 4. RESULTS: General mental health and wellbeing, in addition to a host of unique psychological traits (self-efficacy, resilience, psychological readiness and distress, pain catastrophizing, locus of control, and kinesiophobia) have been demonstrated convincingly to affect treatment outcomes. Moreover, compelling evidence suggests that a number of these traits may be modifiable. Although the effect of resilience on outcomes of orthopaedic surgical procedures has been studied extensively, there is very limited information linking this unique psychological trait to the outcomes of ACLR. Similarly, the available information related to other parameters, such as pain catastrophizing, is limited with respect to the existence of adequately sized cohorts capable of accommodating more rigorous and compelling analyses. A better understanding of the specific mechanisms through which psychological traits influence outcomes can inform future interventions intended to improve rates of return to preinjury level of activity after ACLR. CONCLUSION: The impact of psychology on patients' responses to ACL injury and treatment represents a promising avenue for improving low rates of return to preinjury activity levels among certain cohorts. Future research into these areas should focus on specific effects of targeted interventions on known, modifiable risk factors that commonly contribute to suboptimal clinical outcomes. STRENGTH-OF-RECOMMENDATION TAXONOMY (SORT): B.

Development and Operationalization of an Automated Workflow for Correlation of Knee MRI and Arthroscopy Findings.

OBJECTIVE: In this study, we sought to establish and evaluate an automated workflow to prospectively capture and correlate knee MRI findings with surgical findings in a large medical center. METHODS: This retrospective analysis included data from patients who had undergone knee MRI followed by arthroscopic knee surgery within 6 months during a 2-year period (2019-2020). Discrete data were automatically extracted from a structured knee MRI report template implementing pick lists. Operative findings were recorded discretely by surgeons using a custom-built web-based telephone application. MRI findings were classified as true-positive, true-negative, false-positive, or false-negative for medial meniscus (MM), lateral meniscus (LM), and anterior cruciate ligament (ACL) tears, with arthroscopy used as the reference standard. An automated dashboard displaying up-to-date concordance and individual and group accuracy was enabled for each radiologist. Manual correlation between MRI and operative reports was performed on a random sample of 10% of cases for comparison with automatically derived values. RESULTS: Data from 3,187 patients (1,669 male; mean age, 47 years) were analyzed. Automatic correlation was available for 60% of cases, with an overall MRI diagnostic accuracy of 93% (MM, 92%; LM, 89%; ACL, 98%). In cases reviewed manually, the number of cases that could be correlated with surgery was higher (84%). Concordance between automated and manual review was 99% when both were available (MM, 98%; LM, 100%; ACL, 99%). CONCLUSION: This automated system was able to accurately and continuously assess correlation between imaging and operative findings for a large number of MRI examinations.

The osteoarthritis prevention study (TOPS) - A randomized controlled trial of diet and exercise to prevent Knee Osteoarthritis: Design and rationale.

Background: Osteoarthritis (OA), the leading cause of disability among adults, has no cure and is associated with significant comorbidities. The premise of this randomized clinical trial is that, in a population at risk, a 48-month program of dietary weight loss and exercise will result in less incident structural knee OA compared to control. Methods/design: The Osteoarthritis Prevention Study (TOPS) is a Phase III, assessor-blinded, 48-month, parallel 2 arm, multicenter randomized clinical trial designed to reduce the incidence of structural knee OA. The study objective is to assess the effects of a dietary weight loss, exercise, and weight-loss maintenance program in preventing the development of structural knee OA in females at risk for the disease. TOPS will recruit 1230 ambulatory, community dwelling females with obesity (Body Mass Index (BMI) â€‹≥ â€‹30 â€‹kg/m2) and aged ≥50 years with no radiographic (Kellgren-Lawrence grade ≤1) and no magnetic resonance imaging (MRI) evidence of OA in the eligible knee, with no or infrequent knee pain. Incident structural knee OA (defined as tibiofemoral and/or patellofemoral OA on MRI) assessed at 48-months from intervention initiation using the MRI Osteoarthritis Knee Score (MOAKS) is the primary outcome. Secondary outcomes include knee pain, 6-min walk distance, health-related quality of life, knee joint loading during gait, inflammatory biomarkers, and self-efficacy. Cost effectiveness and budgetary impact analyses will determine the value and affordability of this intervention. Discussion: This study will assess the efficacy and cost effectiveness of a dietary weight loss, exercise, and weight-loss maintenance program designed to reduce incident knee OA. Trial registration: ClinicalTrials.gov Identifier: NCT05946044.

The Effect of Aspiration and Corticosteroid Injection After ACL Injury on Postoperative Infection Rate.

BACKGROUND: Injecting bioactive substances into the knee is common in orthopaedic practice, and recently it has been shown to mitigate risk factors for posttraumatic osteoarthritis. Therefore, understanding the influence of these injections on postoperative infection rate is imperative. HYPOTHESIS: Postinjury aspiration and corticosteroid injection (CSI) of the knee before anterior cruciate ligament (ACL) reconstruction (ACLR) would not increase the risk of postoperative infection. STUDY DESIGN: Cohort Study; Level of evidence, 3. METHODS: All patients between the ages of 10 and 65 years who underwent primary bone-patellar tendon-bone ACLR by 1 fellowship-trained sports medicine orthopaedic surgeon between January 1, 2011, and September 8, 2020, at 1 of 2 major academic centers were evaluated for inclusion. A total of 693 patients were included, with 273 patients receiving postinjury and preoperative aspiration and CSI. A postoperative infection was defined as a patient returning to the operating room for an intra-articular washout. The intervals-measured in days-between the CSI and ACLR and between ACLR and the final follow-up were recorded. To further evaluate the infection risk in each cohort (total cohort; aspiration and injection cohort; no aspiration and injection cohort), the upper 95% confidence bound for the infection risk was calculated for each cohort. RESULTS: There were no postoperative infections in the 693 patients included in this study. The upper 95% confidence bounds were 0.4%, 1.1%, and 0.7% for the total cohort, the cohort that underwent aspiration and injection, and the cohort that did not, respectively. The median number of days between the surgical date and that of the aspiration and injection was 34 days, and the mean follow-up for the entire cohort was 337.4 days (95% CI, 307.6-367.3). CONCLUSION: Postinjury and preoperative aspiration and CSI is a safe intervention that can be used before ACLR. Future studies with larger sample sizes, longer patient follow-ups, and multiple surgeons would be helpful to both better understand infection risk and better identify the influence of CSI on preventing posttraumatic osteoarthritis.

Predictors of Return to Activity at 2 Years After Anterior Cruciate Ligament Reconstruction Among Patients With High Preinjury Marx Activity Scores: A MOON Prospective Cohort Study.

BACKGROUND: Predictors of return to activity after anterior cruciate ligament reconstruction (ACLR) among patients with relatively high preinjury activity levels remain poorly understood. PURPOSE/HYPOTHESIS: The purpose of this study was to identify predictors of return to preinjury levels of activity after ACLR, defined as achieving a Marx activity score within 2 points of the preinjury value, among patients with Marx activity scores of 12 to 16 who had been prospectively enrolled in the Multicenter Orthopaedic Outcomes Network (MOON) cohort. We hypothesized that age, sex, preinjury activity level, meniscal injuries and/or procedures, and concurrent articular cartilage injuries would predict return to preinjury activity levels at 2 years after ACLR. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: All unilateral ACLR procedures from 2002 to 2008 performed in patients enrolled in the MOON, with preinjury Marx activity scores ranging from 12 to 16, were evaluated with a specific focus on return to preinjury activity levels at 2 years postoperatively. Return to activity was defined as a Marx activity score within 2 points of the preinjury value. The proportion of patients able to return to preinjury activity levels was calculated, and multivariable modeling was performed to identify risk factors for patients' inability to return to preinjury activity levels. RESULTS: A total of 1188 patients were included in the final analysis. The median preinjury Marx activity score was 16 (interquartile range, 12-16). Overall, 466 patients (39.2%) were able to return to preinjury levels of activity, and 722 patients (60.8%) were not able to return to preinjury levels of activity. Female sex, smoking at the time of ACLR, fewer years of education, lower 36-Item Short Form Health Survey Mental Component Summary scores, and higher preinjury Marx activity scores were predictive of patients' inability to return to preinjury activity levels. Graft type, revision ACLR, the presence of medial and/or lateral meniscal injuries, a history of meniscal surgery, the presence of articular cartilage injuries, a history of articular cartilage treatment, and the presence of high-grade knee laxity were not predictive of a patient's ability to return to preinjury activity level. CONCLUSION: At 2 years after ACLR, most patients with high preinjury Marx activity scores did not return to their preinjury level of activity. The higher the preinjury Marx activity score that a patient reported at the time of enrollment, the less likely he/she was able to return to preinjury activity level. Smoking and lower mental health at the time of ACLR were the only modifiable risk factors in this cohort that predicted an inability to return to preinjury activity levels. Continued effort and investigation are required to maximize functional recovery after ACLR in patients with high preinjury levels of activity.

One-year patient-reported outcomes following primary arthroscopic rotator cuff repair vary little by surgeon.

Background: This study's purpose was to investigate the extent to which differences among operating surgeons may influence 1-year patient-reported outcome measures (PROMs) in patients undergoing rotator cuff repair (RCR) surgery, after controlling for general and disease-specific patient factors. We hypothesized that surgeon would be additionally associated with 1-year PROMs, specifically the baseline to 1-year improvement in Penn Shoulder Score (PSS). Methods: We used mixed multivariable statistical modeling to assess the influence of surgeon (and alternatively surgical case volume) on 1-year PSS improvement in patients undergoing RCR at a single health system in 2018, controlling for eight patient- and six disease-specific preoperative factors as possible confounders. Contributions of predictors to explaining variation in 1-year PSS improvement were measured and compared using Akaike's Information Criterion. Results: 518 cases performed by 28 surgeons met inclusion criteria, with median (quartiles) baseline PSS of 41.9 (31.9, 53.9) and 1-year PSS improvement of 42 (29.1, 55.3) points. Contrary to expectation, surgeon and surgical case volume were neither statistically significantly nor clinically meaningfully associated with 1-year PSS improvement. Baseline PSS and mental health status (VR-12 MCS) were the dominant and only statistically significant predictors of 1-year PSS improvement, with lower baseline PSS and higher VR-12 MCS predicting larger 1-year PSS improvement. Conclusion: Patients generally reported excellent 1-year outcomes following primary RCR. This study did not find evidence that the individual surgeon or surgeon case volume influences 1-year PROMs, independently of case-mix factors, following primary RCR in a large employed hospital system.

Radiographic Changes Five Years After Treatment of Meniscal Tear and Osteoarthritic Changes.

OBJECTIVE: Meniscal tear in persons aged ≥45 years is typically managed with physical therapy (PT), and arthroscopic partial meniscectomy (APM) is offered to those who do not respond. Prior studies suggest APM may be associated with greater progression of radiographic changes. METHODS: We assessed changes between baseline and 60 months in the Kellgren-Lawrence (KL) grade and OARSI radiographic score (including subscores for joint space narrowing and osteophytes) in subjects aged 45-85 years enrolled into a seven-center randomized trial comparing outcomes of APM with PT for meniscal tear, osteoarthritis changes, and knee pain. The primary analysis classified subjects according to treatment received. To balance APM and PT groups, we developed a propensity score and used inverse probability weighting (IPW). We imputed a 60-month change in the OARSI score for subjects who underwent total knee replacement (TKR). In a sensitivity analysis, we classified subjects by randomization group. RESULTS: We analyzed data from 142 subjects (100 APM, 42 PT). The mean ± SD weighted baseline OARSI radiographic score was 3.8 ± 3.5 in the APM group and 4.0 ± 4.9 in the PT group. OARSI scores increased by a mean of 4.1 (95% confidence interval [95% CI] 3.5-4.7) in the APM group and 2.4 (95% CI 1.7-3.2) in the PT group (P < 0.001) due to changes in the osteophyte component. We did not observe statistically significant differences in the KL grade. Sensitivity analyses yielded similar findings to the primary analysis. CONCLUSION: Subjects treated with APM had greater progression in the OARSI score because of osteophyte progression but not in the KL grade. The clinical implications of these findings require investigation.

External Validation of the KOOS-ACL in the MOON Group Cohort of Young Athletes Followed for 10 Postoperative Years.

BACKGROUND: The Knee injury and Osteoarthritis Outcome Score-Anterior Cruciate Ligament (KOOS-ACL) is a short form version of the KOOS, developed to target populations of young active patients with ACL tears. The KOOS-ACL consists of 2 subscales: Function (8 items) and Sport (4 items). The KOOS-ACL was developed and validated using data from the Stability 1 study from baseline to postoperative 2 years. PURPOSE: To validate the KOOS-ACL in an external sample of patients matching the outcome's target population. STUDY DESIGN: Cohort study (diagnosis); Level of evidence, 1. METHODS: The Multicenter Orthopaedic Outcomes Network group cohort of 839 patients aged 14 to 22 years who tore their ACLs while playing sports was used to assess internal consistency reliability, structural validity, convergent validity, responsiveness to change, and floor/ceiling effects of the KOOS-ACL at 4 time points: baseline and postoperative 2, 6, and 10 years. Detection of treatment effects between graft type (hamstring tendon vs bone-patellar tendon-bone) were also compared between the full-length KOOS and KOOS-ACL. RESULTS: The KOOS-ACL demonstrated acceptable internal consistency reliability (α = .82-.89), structural validity (Tucker-Lewis index and comparative fit index = 0.98-0.99; standardized root mean square residual and root mean square error of approximation = 0.04-0.07), convergent validity (Spearman correlation with International Knee Documentation Committee subjective knee form = 0.66-0.85; Western Ontario and McMaster Universities Osteoarthritis Index function = 0.84-0.95), and responsiveness to change across time (large effect sizes from baseline to postoperative 2 years; d = 0.94 [Function] and d = 1.54 [Sport]). Stable scores and significant ceiling effects were seen from 2 to 10 years. No significant differences in KOOS or KOOS-ACL scores were detected between patients with different graft types. CONCLUSION: The KOOS-ACL shows improved structural validity when compared with the full-length KOOS and adequate psychometric properties in a large external sample of high school and college athletes. This strengthens the argument to use the KOOS-ACL to assess young active patients with ACL tears in clinical research and practice.

The Corticosteroid Meniscectomy Trial of Extended-Release Triamcinolone Injection After Arthroscopic Partial Meniscectomy: Protocol for a Double-Blind Randomized Controlled Trial.

Background: Meniscal tear in older adults often accompanies knee osteoarthritis and is commonly treated with arthroscopic partial meniscectomy (APM) when patients have persistent pain after a trial of physical therapy. Cross-sectional evidence suggests that synovitis is associated with baseline pain in this patient population, but little is known about the relationship between synovitis and postoperative recovery or progression of knee osteoarthritis. Purpose/Hypothesis: Intra-articular extended-release triamcinolone may reduce inflammation and thereby improve outcomes and slow disease progression. This article presents the rationale behind the Corticosteroid Meniscectomy Trial (CoMeT) and describes its study design and implementation strategies. Study Design: Randomized controlled trial. Methods: CoMeT is a 2-arm, 3-center, randomized placebo-controlled trial designed to establish the clinical efficacy of extended-release triamcinolone administered via intra-articular injection immediately after APM. The primary outcome is change in Knee injury and Osteoarthritis Outcome Score Pain subscore at 3-month follow-up. Synovial biopsy, joint fluid aspirate, and urine and blood sample analyses will examine the associations between various objective measures of baseline inflammation and pre- and postoperative outcome measures and clinical responses to triamcinolone intervention. Quantitative 3-T magnetic resonance imaging will evaluate cartilage and meniscal composition and 3-dimensional bone shape to detect early joint degeneration. Results: We discuss methodologic innovations and challenges. Conclusion: To our knowledge, this is the first randomized double-blind clinical trial that will analyze the effect of extended-release triamcinolone acetonide on pain, magnetic resonance imaging measures of structural change and effusion/synovitis, soluble biomarkers, and synovial tissue transcriptomics after APM.

Deep learning-based automatic pipeline for quantitative assessment of thigh muscle morphology and fatty infiltration.

PURPOSE: Fast and accurate thigh muscle segmentation from MRI is important for quantitative assessment of thigh muscle morphology and composition. A novel deep learning (DL) based thigh muscle and surrounding tissues segmentation model was developed for fully automatic and reproducible cross-sectional area (CSA) and fat fraction (FF) quantification and tested in patients at 10 years after anterior cruciate ligament reconstructions. METHODS: A DL model combining UNet and DenseNet was trained and tested using manually segmented thighs from 16 patients (32 legs). Segmentation accuracy was evaluated using Dice similarity coefficients (DSC) and average symmetric surface distance (ASSD). A UNet model was trained for comparison. These segmentations were used to obtain CSA and FF quantification. Reproducibility of CSA and FF quantification was tested with scan and rescan of six healthy subjects. RESULTS: The proposed UNet and DenseNet had high agreement with manual segmentation (DSC >0.97, ASSD < 0.24) and improved performance compared with UNet. For hamstrings of the operated knee, the automated pipeline had largest absolute difference of 6.01% for CSA and 0.47% for FF as compared to manual segmentation. In reproducibility analysis, the average difference (absolute) in CSA quantification between scan and rescan was better for the automatic method as compared with manual segmentation (2.27% vs. 3.34%), whereas the average difference (absolute) in FF quantification were similar. CONCLUSIONS: The proposed method exhibits excellent accuracy and reproducibility in CSA and FF quantification compared with manual segmentation and can be used in large-scale patient studies.

Meniscal and Articular Cartilage Predictors of Outcome After Revision ACL Reconstruction: A 6-Year Follow-up Cohort Study.

BACKGROUND: Meniscal and chondral damage is common in the patient undergoing revision anterior cruciate ligament (ACL) reconstruction. PURPOSE: To determine if meniscal and/or articular cartilage pathology at the time of revision ACL surgery significantly influences a patient's outcome at 6-year follow-up. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: Patients undergoing revision ACL reconstruction were prospectively enrolled between 2006 and 2011. Data collection included baseline demographics, surgical technique, pathology, treatment, and scores from 4 validated patient-reported outcome instruments: International Knee Documentation Committee (IKDC), Knee injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Marx Activity Rating Scale. Patients were followed up at 6 years and asked to complete the identical set of outcome instruments. Regression analysis assessed the meniscal and articular cartilage pathology risk factors for clinical outcomes 6 years after revision ACL reconstruction. RESULTS: An overall 1234 patients were enrolled (716 males, 58%; median age, 26 years). Surgeons reported the pathology at the time of revision surgery in the medial meniscus (45%), lateral meniscus (36%), medial femoral condyle (43%), lateral femoral condyle (29%), medial tibial plateau (11%), lateral tibial plateau (17%), patella (30%), and trochlea (21%). Six-year follow-up was obtained on 79% of the sample (980/1234). Meniscal pathology and articular cartilage pathology (medial femoral condyle, lateral femoral condyle, lateral tibial plateau, trochlea, and patella) were significant drivers of poorer patient-reported outcomes at 6 years (IKDC, KOOS, WOMAC, and Marx). The most consistent factors driving outcomes were having a medial meniscal excision (either before or at the time of revision surgery) and patellofemoral articular cartilage pathology. Six-year Marx activity levels were negatively affected by having either a repair/excision of the medial meniscus (odds ratio range, 1.45-1.72; P≤ .04) or grade 3-4 patellar chondrosis (odds ratio, 1.72; P = .04). Meniscal pathology occurring before the index revision surgery negatively affected scores on all KOOS subscales except for sports/recreation (P < .05). Articular cartilage pathology significantly impaired all KOOS subscale scores (P < .05). Lower baseline outcome scores, higher body mass index, being a smoker, and incurring subsequent surgery all significantly increased the odds of reporting poorer clinical outcomes at 6 years. CONCLUSION: Meniscal and chondral pathology at the time of revision ACL reconstruction has continued significant detrimental effects on patient-reported outcomes at 6 years after revision surgery.

Do Patellar Tendon Repairs Have Better Outcomes than Quadriceps Tendon Repairs? A Prospective Cohort Analysis.

Patellar tendon (PT) and quadriceps tendon (QT) ruptures represent significant injuries and warrant surgical intervention in most patients. Outcome data are predominantly retrospective analyses with low sample sizes. There are also minimal data comparing QT and PT repairs and the variables impacting patient outcomes. The level of evidence of the study is level II (prognosis). From the prospective OME cohort, 189 PT or QT repairs were performed between February 2015 and October 2019. Of these, 178 were successfully enrolled (94.2%) with 1-year follow-up on 141 (79.2%). Baseline demographic data included age, sex, race, BMI, years of education, smoking status, and baseline VR-12 MCS score. Surgical and follow-up data included surgeon volume, fixation technique, baseline, and 1-year Knee Injury and Osteoarthritis Outcome Score-Pain (KOOS-Pain), Knee Injury and Osteoarthritis Outcome Score-Physical Function (KOOS-PS), and 1-year Patient Acceptable Symptom State (PASS) scores and complications. Multivariable regression analysis was utilized to identify prognosis and significant risk factors for outcomes-specifically, whether KOOS-Pain or KOOS-PS were different between QT versus PT repairs. There were 59 patients in the PT cohort and 82 patients in QT cohort. Baseline demographic data demonstrated that PT cohort was younger (45.1 vs. 59.5 years, p <0.001), included significantly fewer patients of White race (51.7 vs. 80.0%, p = 0.001), lesser number of years of education (13.9 vs. 15.2 years, p = 0.020), a higher percentage of "high" surgeon volume (72.9% vs. 43.9%, p = 0.001) and 25.4% of PT repairs had supplemental fixation (QT had zero, p <0.001). Multivariable analysis identified gender (female-worse, p = 0.001), years of education (higher-better, p = 0.02), and baseline KOOS-Pain score (higher-better, p <0.001) as the risk factors that significantly predicted KOOS-Pain score. The risk factors that significantly predicted KOOS-PS were gender (female worse, p = 0.033), race (non-White-worse, p <0.001), baseline VR-12 MCS score (higher-better, p <0.001), and baseline KOOS-PS score (higher better, p = 0.029). KOOS-Pain and KOOS-PS scores improved after both QT and PT repairs. Patient reported pain and function at 1 year were similar between PT and QT repairs after adjusting for known risk factors. Multivariable analysis identified female gender and low baseline KOOS scores as predictors for worse outcomes.

Association Between Structural Change Over Eighteen Months and Subsequent Symptom Change in Middle-Aged Patients Treated for Meniscal Tear.

OBJECTIVE: Middle-aged subjects with meniscal tear treated with arthroscopic partial meniscectomy (APM) experience greater progression of damage to joint structures on imaging than subjects treated nonoperatively. It is unclear whether these changes are clinically relevant. The goal of this study was to assess whether worsening in magnetic resonance imaging (MRI)-assessed tissue damage over 18 months leads to subsequent worsening in knee pain over the subsequent 3.5 years. METHODS: We used data from the Meniscal Tear in Osteoarthritis Research (MeTeOR) trial of APM versus physical therapy for subjects ages ≥45 years with knee pain, cartilage damage, and meniscal tear. We assessed whether change in cartilage surface area damage score (and other structural measures) from baseline to 18 months, assessed on MRI with the MRI Osteoarthritis Knee Score (MOAKS) system, was associated with change in Knee Injury and Osteoarthritis Outcome Score (KOOS) pain score (range 0-100; 100 = worst) from 18 to 60 months. RESULTS: The primary analysis included 168 subjects with complete MRI data at baseline and 18 months and KOOS data at 18 and 60 months. We did not observe clinically important associations between change in cartilage surface area score between baseline and 18 months and change in pain scores from 18 to 60 months. Pain scores in the worst tertile for cartilage surface area damage score progression worsened by 0.45 points more than in the best tertile (95% confidence interval -4.45, 5.35). Similarly, we did not observe clinically important associations between changes in bone marrow lesions, osteophytes, or synovitis and subsequent pain. CONCLUSION: We did not observe clinically important associations between early changes in cartilage damage and other structural measures and worsening in pain over the subsequent 3.5 years. Further follow-up is required to assess this association over a longer follow-up period.

Regulatory and Ethical Aspects of Orthobiologic Therapies.

Orthobiologic therapies show significant promise to improve outcomes for patients with musculoskeletal pathology. There are considerable research efforts to develop strategies that seek to modulate the biological environment to promote tissue regeneration and healing and/or provide symptomatic relief. However, the regulatory pathways overseeing the clinical translation of these therapies are complex, with considerable worldwide variation. The introduction of novel biologic treatments into clinical practice raises several ethical dilemmas. In this review, we describe the process for seeking approval for biologic therapies in the United States, Europe, and Japan. We highlight a number of ethical issues raised by the clinical translation of these treatments, including the design of clinical trials, monitoring outcomes, biobanking, "off-label" use, engagement with the public, marketing of unproven therapies, and scientific integrity.

Optimizing Use of Large Databases in Joint Arthroplasty and Orthopaedics.

The potential users of "big data" need to consider many factors when choosing whether to use a large observational database for their research question and, if so, which database is the best fit for the scientific question. The first section of this paper, written by Dr. James A. Browne, provides a framework (who, what, where, when, and why?) to assess the critical elements that are included in a large database, which allows the user to determine if interrogation of the data is likely to answer the research question. The next section of this paper, written by Dr. Bryan Springer, focuses on the importance of having an a priori research question before deciding the best data source to answer the question; it also elaborates on the differences between administrative databases and clinical databases. The final section of the paper, written by Dr. Kurt P. Spindler, reviews the concepts of hypothesis-generating and hypothesis-testing studies and discusses in detail the differences, strengths, limitations, and appropriate uses of observational data versus randomized controlled trials.