المؤلفون: Spindler, Kurt P., Imrey, Peter B., Yalcin, Sercan, Beck, Gerald J., Calbrese, Gary, Cox, Charles L., Fadale, Paul D., Farrow, Lutul, Fitch, Robert, Flanigan, David, Fleming, Braden C., Hulstyn, Michael J., Jones, Morgan H., Kaeding, Christopher, Katz, Jeffrey N., Kriz, Peter, Magnussen, Robert, McErlean, Ellen, Melgaard, Carrie, Owens, Brett D.

المصدر: Orthopaedic Journal of Sports Medicine; Jan2022, Vol. 10 Issue 1, p1-13, 13p

مصطلحات موضوعية: TRAUMA surgery, RESEARCH, CONFIDENCE intervals, MEDICAL cooperation, HEALTH outcome assessment, TREATMENT effectiveness, RANDOMIZED controlled trials, DESCRIPTIVE statistics, ANTERIOR cruciate ligament surgery, STATISTICAL sampling, EVALUATION

مستخلص: Background: BEAR (bridge-enhanced anterior cruciate ligament [ACL] restoration), a paradigm-shifting technology to heal midsubstance ACL tears, has been demonstrated to be effective in a single-center 2:1 randomized controlled trial (RCT) versus hamstring ACL reconstruction. Widespread dissemination of BEAR into clinical practice should also be informed by a multicenter RCT to demonstrate exportability and compare efficacy with bone--patellar tendon–bone (BPTB) ACL reconstruction, another clinically standard treatment. Purpose: To present the design and initial preparation of a multicenter RCT of BEAR versus BPTB ACL reconstruction (the BEAR: Multicenter Orthopaedic Outcomes Network [BEAR-MOON] trial). Design and analytic issues in planning the complex BEAR-MOON trial, involving the US National Institute of Arthritis and Musculoskeletal and Skin Diseases, the US Food and Drug Administration, the BEAR implant manufacturer, a data and safety monitoring board, and institutional review boards, can usefully inform both clinicians on the trial's strengths and limitations and future investigators on planning of complex orthopaedic studies. Study Design: Clinical trial. Methods: We describe the distinctive clinical, methodological, and operational challenges of comparing the innovative BEAR procedure with the well-established BPTB operation, and we outline the clinical motivation, experimental setting, study design, surgical challenges, rehabilitation, outcome measures, and planned analysis of the BEAR-MOON trial. Results: BEAR-MOON is a 6-center, 12-surgeon, 200-patient randomized, partially blinded, noninferiority RCT comparing BEAR with BPTB ACL reconstruction for treating first-time midsubstance ACL tears. Noninferiority of BEAR relative to BPTB will be claimed if the total score on the International Knee Documentation Committee (IKDC) subjective knee evaluation form and the knee arthrometer 30-lb (13.61-kg) side-to-side laxity difference are both within respective margins of 16 points for the IKDC and 2.5 mm for knee laxity. Conclusion: Major issues include patient selection, need for intraoperative randomization and treatment-specific postoperative physical therapy regimens (because of fundamental differences in surgical technique, initial stability construct, and healing), and choice of noninferiority margins for short-term efficacy outcomes of a novel intervention with evident short-term advantages and theoretical, but unverified, long-term benefits on other dimensions. [ABSTRACT FROM AUTHOR]

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المؤلفون: Losina, Elena, Michl, Griffin L., Smith, Karen C., Katz, Jeffrey N.

المصدر: Arthritis Care & Research; Aug2017, Vol. 69 Issue 8, p1164-1170, 7p

مصطلحات موضوعية: COMPARATIVE studies, INTERNET, KNEE diseases, RESEARCH methodology, MEDICAL cooperation, OSTEOARTHRITIS, PATIENT education, SENSORY perception, RESEARCH, RESEARCH funding, RISK assessment, EVALUATION research, RANDOMIZED controlled trials, TREATMENT effectiveness, EARLY medical intervention, PREVENTION

مستخلص: Objective: Young adults, in general, are not aware of their risk of knee osteoarthritis (OA). Understanding risk and risk factors is critical to knee OA prevention. We tested the efficacy of a personalized risk calculator on accuracy of knee OA risk perception and willingness to change behaviors associated with knee OA risk factors.Methods: We conducted a randomized controlled trial of 375 subjects recruited using Amazon Mechanical Turk. Subjects were randomized to either use a personalized risk calculator based on demographic and risk-factor information (intervention), or to view general OA risk information (control). At baseline and after the intervention, subjects estimated their 10-year and lifetime risk of knee OA and responded to contemplation ladders measuring willingness to change diet, exercise, or weight-control behaviors.Results: Subjects in both arms had an estimated 3.6% 10-year and 25.3% lifetime chance of developing symptomatic knee OA. Both arms greatly overestimated knee OA risk at baseline, estimating a 10-year risk of 26.1% and a lifetime risk of 47.8%. After the intervention, risk calculator subjects' perceived 10-year risk decreased by 12.9 percentage points to 12.5% and perceived lifetime risk decreased by 19.5 percentage points to 28.1%. Control subjects' perceived risks remained unchanged. Risk calculator subjects were more likely to move to an action stage on the exercise contemplation ladder (relative risk 2.1). There was no difference between the groups for diet or weight-control ladders.Conclusion: The risk calculator is a useful intervention for knee OA education and may motivate some exercise-related behavioral change. [ABSTRACT FROM AUTHOR]

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المؤلفون: Solomon, Daniel H., Losina, Elena, Lu, Bing, Zak, Agnes, Corrigan, Cassandra, Lee, Sara B., Agosti, Jenifer, Bitton, Asaf, Harrold, Leslie R., Pincus, Theodore, Radner, Helga, Yu, Zhi, Smolen, Josef S., Fraenkel, Liana, Katz, Jeffrey N.

المصدر: Arthritis & Rheumatology; Jul2017, Vol. 69 Issue 7, p1374-1380, 7p

مصطلحات موضوعية: CLINICAL trials, INTERPROFESSIONAL relations, LEARNING strategies, MEDICAL cooperation, PROBABILITY theory, PROFESSIONAL employee training, QUALITY assurance, REGRESSION analysis, RESEARCH, RHEUMATOID arthritis, STATISTICAL sampling, RANDOMIZED controlled trials, DESCRIPTIVE statistics

مصطلحات جغرافية: UNITED States

مستخلص: Objective Treat-to-target (TTT) is an accepted paradigm for the management of rheumatoid arthritis (RA), but some evidence suggests poor adherence. The purpose of this study was to test the effects of a group-based multisite improvement learning collaborative on adherence to TTT. Methods We conducted a cluster-randomized quality-improvement trial with waitlist control across 11 rheumatology sites in the US. The intervention entailed a 9-month group-based learning collaborative that incorporated rapid-cycle improvement methods. A composite TTT implementation score was calculated as the percentage of 4 required items documented in the visit notes for each patient at 2 time points, as evaluated by trained staff. The mean change in the implementation score for TTT across all patients for the intervention sites was compared with that for the control sites after accounting for intracluster correlation using linear mixed models. Results Five sites with a total of 23 participating rheumatology providers were randomized to intervention and 6 sites with 23 participating rheumatology providers were randomized to the waitlist control. The intervention included 320 patients, and the control included 321 patients. At baseline, the mean TTT implementation score was 11% in both arms; after the 9-month intervention, the mean TTT implementation score was 57% in the intervention group and 25% in the control group (change in score of 46% for intervention and 14% for control; P = 0.004). We did not observe excessive use of resources or excessive occurrence of adverse events in the intervention arm. Conclusion A learning collaborative resulted in substantial improvements in adherence to TTT for the management of RA. This study supports the use of an educational collaborative to improve quality. [ABSTRACT FROM AUTHOR]

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المؤلفون: Barbhaiya, Medha, Yan Dong, Sparks, Jeffrey A., Losina, Elena, Costenbader, Karen H., Katz, Jeffrey N., Dong, Yan

المصدر: BMC Musculoskeletal Disorders; 6/19/2017, Vol. 18, p1-6, 6p, 3 Charts

مصطلحات موضوعية: OSTEONECROSIS, OSTEORADIOGRAPHY, MAGNETIC resonance imaging, EPIDEMIOLOGY, ALGORITHMS, ARM, COMPARATIVE studies, LEG, RESEARCH methodology, MEDICAL cooperation, NOSOLOGY, RESEARCH, RESEARCH funding, EVALUATION research

مستخلص: Background: Studies of the epidemiology and outcomes of avascular necrosis (AVN) require accurate case-finding methods. The aim of this study was to evaluate performance characteristics of a claims-based algorithm designed to identify AVN cases in administrative data.Methods: Using a centralized patient registry from a US academic medical center, we identified all adults aged ≥18 years who underwent magnetic resonance imaging (MRI) of an upper/lower extremity joint during the 1.5 year study period. A radiologist report confirming AVN on MRI served as the gold standard. We examined the sensitivity, specificity, positive predictive value (PPV) and positive likelihood ratio (LR+) of four algorithms (A-D) using International Classification of Diseases, 9th edition (ICD-9) codes for AVN. The algorithms ranged from least stringent (Algorithm A, requiring ≥1 ICD-9 code for AVN [733.4X]) to most stringent (Algorithm D, requiring ≥3 ICD-9 codes, each at least 30 days apart).Results: Among 8200 patients who underwent MRI, 83 (1.0% [95% CI 0.78-1.22]) had AVN by gold standard. Algorithm A yielded the highest sensitivity (81.9%, 95% CI 72.0-89.5), with PPV of 66.0% (95% CI 56.0-75.1). The PPV of algorithm D increased to 82.2% (95% CI 67.9-92.0), although sensitivity decreased to 44.6% (95% CI 33.7-55.9). All four algorithms had specificities >99%.Conclusion: An algorithm that uses a single billing code to screen for AVN among those who had MRI has the highest sensitivity and is best suited for studies in which further medical record review confirming AVN is feasible. Algorithms using multiple billing codes are recommended for use in administrative databases when further AVN validation is not feasible. [ABSTRACT FROM AUTHOR]

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المؤلفون: Katz, Jeffrey N., Smith, Savannah R., Yang, Heidi Y., Martin, Scott D., Wright, John, Donnell-Fink, Laurel A., Losina, Elena

المصدر: Arthritis Care & Research; Apr2017, Vol. 69 Issue 4, p484-490, 7p

مصطلحات موضوعية: OSTEOARTHRITIS diagnosis, AGE distribution, COMPARATIVE studies, KNEE diseases, RESEARCH methodology, MEDICAL cooperation, MEDICAL history taking, MENISCUS (Anatomy), MULTIVARIATE analysis, OSTEOARTHRITIS, PHYSICAL diagnosis, RESEARCH, RESEARCH evaluation, RESEARCH funding, LOGISTIC regression analysis, EVALUATION research, PAIN measurement, PREDICTIVE tests, DISEASE prevalence, CROSS-sectional method, JOINT pain, ODDS ratio, DIAGNOSIS

مصطلحات جغرافية: MASSACHUSETTS

مستخلص: Objective: To evaluate the utility of clinical history, radiographic findings, and physical examination findings in the diagnosis of symptomatic meniscal tear (SMT) in patients over age 45 years, in whom concomitant osteoarthritis is prevalent.Methods: In a cross-sectional study of patients from 2 orthopedic surgeons' clinics, we assessed clinical history, physical examination findings, and radiographic findings in patients age >45 years with knee pain. The orthopedic surgeons rated their confidence that subjects' symptoms were due to meniscal tear; we defined the diagnosis of SMT as at least 70% confidence. We used logistic regression to identify factors independently associated with diagnosis of SMT, and we used the regression results to construct an index of the likelihood of SMT.Results: In 174 participants, 6 findings were associated independently with the expert clinician having ≥70% confidence that symptoms were due to meniscal tear: localized pain, ability to fully bend the knee, pain duration <1 year, lack of varus alignment, lack of pes planus, and absence of joint space narrowing on radiographs. The index identified a low-risk group with 3% likelihood of SMT.Conclusion: While clinicians traditionally rely upon mechanical symptoms in this diagnostic setting, our findings did not support the conclusion that mechanical symptoms were associated with the expert's confidence that symptoms were due to meniscal tear. An index that includes history of localized pain, full flexion, duration <1 year, pes planus, varus alignment, and joint space narrowing can be used to stratify patients according to their risk of SMT, and it identifies a subgroup with very low risk. [ABSTRACT FROM AUTHOR]

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المؤلفون: Byers Kraus, Virginia, Collins, Jamie E., Hargrove, David, Losina, Elena, Nevitt, Michael, Katz, Jeffrey N., Wang, Susanne X., Sandell, Linda J., Hoffmann, Steven C., Hunter, David J., Kraus, Virginia Byers, OA Biomarkers Consortium

المصدر: Annals of the Rheumatic Diseases; Jan2017, Vol. 76 Issue 1, p186-195, 10p, 5 Charts, 1 Graph

مصطلحات موضوعية: OSTEOARTHRITIS diagnosis, COMPARATIVE studies, KNEE diseases, RESEARCH methodology, MEDICAL cooperation, OSTEOARTHRITIS, PROGNOSIS, RADIOGRAPHY, RESEARCH, RESEARCH funding, EVALUATION research, PAIN measurement, PREDICTIVE tests, SEVERITY of illness index, CASE-control method, RECEIVER operating characteristic curves, DISEASE progression, DIAGNOSIS

مستخلص: Objective: To investigate a targeted set of biochemical biomarkers as predictors of clinically relevant osteoarthritis (OA) progression.Methods: Eighteen biomarkers were measured at baseline, 12 months (M) and 24 M in serum (s) and/or urine (u) of cases (n=194) from the OA initiative cohort with knee OA and radiographic and persistent pain worsening from 24 to 48 M and controls (n=406) not meeting both end point criteria. Primary analyses used multivariable regression models to evaluate the association between biomarkers (baseline and time-integrated concentrations (TICs) over 12 and 24 M, transposed to z values) and case status, adjusted for age, sex, body mass index, race, baseline radiographic joint space width, Kellgren-Lawrence grade, pain and pain medication use. For biomarkers with adjusted p<0.1, the c-statistic (area under the curve (AUC)), net reclassification index and the integrated discrimination improvement index were used to further select for hierarchical multivariable discriminative analysis and to determine the most predictive and parsimonious model.Results: The 24 M TIC of eight biomarkers significantly predicted case status (ORs per 1 SD change in biomarker): sCTXI 1.28, sHA 1.22, sNTXI 1.25, uC2C-HUSA 1.27, uCTXII, 1.37, uNTXI 1.29, uCTXIα 1.32, uCTXIβ 1.27. 24 M TIC of uCTXII (1.47-1.72) and uC2C-Human Urine Sandwich Assay (HUSA) (1.36-1.50) both predicted individual group status (pain worsening, joint space loss and their combination). The most predictive and parsimonious combinatorial model for case status consisted of 24 M TIC uCTXII, sHA and sNTXI (AUC 0.667 adjusted). Baseline uCTXII and uCTXIα both significantly predicted case status (OR 1.29 and 1.20, respectively).Conclusions: Several systemic candidate biomarkers hold promise as predictors of pain and structural worsening of OA. [ABSTRACT FROM AUTHOR]

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المؤلفون: Katz, Jeffrey N.^1,2,3,4,5,6 jnkatz@partners.org, Wright, John^1,2,3,4,5,6, Spindler, Kurt P.^1,2,3,4,5,6, Mandl, Lisa A.^1,2,3,4,5,6, Safran-Norton, Clare E.^1,2,3,4,5,6, Reinke, Emily K.^1,2,3,4,5,6, Levy, Bruce A.^1,2,3,4,5,6, Wright, Rick W.^1,2,3,4,5,6, Jones, Morgan H.^1,2,3,4,5,6, Martin, Scott D.^1,2,3,4,5,6, Marx, Robert G.^1,2,3,4,5,6, Losina, Elena^1,2,3,4,5,6

المصدر: Journal of Bone & Joint Surgery, American Volume. 11/16/2016, Vol. 98 Issue 22, p1890-1896. 7p.

مصطلحات موضوعية: *OSTEOARTHRITIS treatment, *MENISCECTOMY, *DISEASE duration, *PAIN management, *TREATMENT effectiveness, *KNEE surgery, *COMPARATIVE studies, *CONVALESCENCE, *CROSSOVER trials, *KNEE diseases, *RESEARCH methodology, *MEDICAL cooperation, *ORTHOPEDIC surgery, *OSTEOARTHRITIS, *PHYSICAL therapy, *PROGNOSIS, *QUESTIONNAIRES, *RESEARCH, *RESEARCH funding, *ACTIVITIES of daily living, *EVALUATION research, *PAIN measurement, *RANDOMIZED controlled trials, *THERAPEUTICS

مستخلص: Background: Arthroscopic partial meniscectomy (APM) combined with physical therapy (PT) have yielded pain relief similar to that provided by PT alone in randomized trials of subjects with a degenerative meniscal tear. However, many patients randomized to PT received APM before assessment of the primary outcome. We sought to identify factors associated with crossing over to APM and to compare pain relief between patients who had crossed over to APM and those who had been randomized to APM.Methods: We used data from the MeTeOR (Meniscal Tear in Osteoarthritis Research) Trial of APM with PT versus PT alone in subjects ≥45 years old who had mild-to-moderate osteoarthritis and a degenerative meniscal tear. We assessed independent predictors of crossover to APM among those randomized to PT. We also compared pain relief at 6 months among those randomized to PT who crossed over to APM, those who did not cross over, and those originally randomized to APM.Results: One hundred and sixty-four subjects were randomized to and received APM and 177 were randomized to PT, of whom 48 (27%) crossed over to receive APM in the first 140 days after randomization. In multivariate analyses, factors associated with a higher likelihood of crossing over to APM among those who had originally been randomized to PT included a baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score of ≥40 (risk ratio [RR] = 1.99; 95% confidence interval [CI] = 1.00, 3.93) and symptom duration of <1 year (RR = 1.74; 95% CI = 0.98, 3.08). Eighty-one percent of subjects who crossed over to APM and 82% of those randomized to APM had an improvement of ≥10 points in their pain score at 6 months, as did 73% of those who were randomized to and received only PT.Conclusions: Subjects who crossed over to APM had presented with a shorter symptom duration and greater baseline pain than those who did not cross over from PT. Subjects who crossed over had rates of surgical success similar to those of the patients who had been randomized to surgery. Our findings also suggest that an initial course of rigorous PT prior to APM may not compromise surgical outcome.Level Of Evidence: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

المؤلفون: Losina, Elena, Collins, Jamie E., Wright, John, Daigle, Meghan E., Donnell-Fink, Laurel A., Strnad, Doris, Usiskin, Ilana M., Yang, Heidi Y., Lerner, Vladislav, Katz, Jeffrey N.

المصدر: Arthritis Care & Research; Sep2016, Vol. 68 Issue 9, p1252-1259, 8p

مصطلحات موضوعية: COMPARATIVE studies, CONVALESCENCE, KNEE diseases, RESEARCH methodology, MEDICAL cooperation, OSTEOARTHRITIS, PAIN, POSTOPERATIVE care, RESEARCH, RESEARCH funding, TOTAL knee replacement, EVALUATION research, RANDOMIZED controlled trials, MOTIVATIONAL interviewing, REHABILITATION

مستخلص: Objective: To establish the efficacy of motivational interviewing-based postoperative care navigation in improving functional status after total knee arthroplasty (TKA) and to identify subgroups likely to benefit from the intervention.Methods: We conducted a parallel randomized controlled trial in TKA recipients with 2 arms: postoperative care with frequent followup by a care navigator or usual care. The primary outcome was the difference between the arms in Western Ontario and McMaster Universities Osteoarthritis Index function score change, over 6 months postsurgery. We performed a preplanned subgroup analysis of differential efficacy by obesity and exploratory subgroup analyses on sex and pain catastrophizing.Results: We enrolled 308 subjects undergoing TKA for osteoarthritis. Mean ± SD preoperative function score was 41 ± 17 (0-100 scale, where 100 = worst function). At 6 months, subjects in the navigation arm improved by mean ± SD 30 ± 16 points compared to 27 ± 18 points in the usual-care arm (P = 0.148). Participants with moderate to high levels of pain catastrophizing were unlikely to benefit from navigation compared to those with lower levels of pain catastrophizing (P = 0.013 for interaction).Conclusion: Subjects assigned to the navigation intervention did not demonstrate greater functional improvement compared to those in the control group. The negative overall result could be explained by the large effect on functional improvement of TKA itself compared to the smaller, additional benefit from care navigation, as well as by potential differential effects for subjects with moderate to high degrees of pain catastrophizing. Greater focus on developing programs for reducing pain catastrophizing could lead to better functional outcomes following TKA. [ABSTRACT FROM AUTHOR]

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المؤلفون: Usiskin, Ilana M., Yang, Heidi Y., Deshpande, Bhushan R., Collins, Jamie E., Michl, Griffin L., Smith, Savannah R., Klara, Kristina M., Selzer, Faith, Katz, Jeffrey N., Losina, Elena

المصدر: BMC Musculoskeletal Disorders; 9/1/2016, Vol. 17, p1-9, 9p, 2 Charts, 2 Graphs

مصطلحات موضوعية: TOTAL knee replacement, OSTEOARTHRITIS, KNEE surgery, RANDOMIZED controlled trials, PAIN tolerance, COMPARATIVE studies, RESEARCH methodology, MEDICAL cooperation, PAIN, RESEARCH, RESEARCH funding, ACTIVITIES of daily living, EVALUATION research, PAIN measurement, PATIENT selection, PREOPERATIVE period

مستخلص: Background: Historically, persons scheduled for total knee arthroplasty (TKA) have reported severe pain with low demand activities such as walking, but recent data suggests that TKA recipients may have less preoperative pain. Little is known about people who elect TKA with low levels of preoperative pain. To better understand current TKA utilization, we evaluated the association between preoperative pain and difficulty performing high demand activities, such as kneeling and squatting, among TKA recipients.Methods: We used baseline data from a randomized control trial designed to improve physical activity following TKA. Prior to TKA, participants were categorized according to Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain scores: Low (0-25), Medium (26-40), and High (41-100). Within each group, limitations in both low demand and high demand activities were assessed.Results: The sample consisted of 202 persons with a mean age of 65 (SD 8) years; 21 %, 34 %, and 45 % were categorized in the Low, Medium, and High Pain groups, respectively. Of the Low Pain group, 60 % reported at least one of the following functional limitations: limited flexion, limp, limited walking distance, and limitations in work or housework. While only 12 % of the Low Pain group reported at least moderate pain with walking on a flat surface, nearly all endorsed at least moderate difficulty with squatting and kneeling.Conclusions: A substantial number of persons scheduled for TKA report Low WOMAC Pain (≤25) prior to surgery. Persons with Low WOMAC Pain scheduled for TKA frequently report substantial difficulty with high demand activities such as kneeling and squatting. Studies of TKA appropriateness and effectiveness for patients with low WOMAC Pain should include measures of these activities.Trial Registration: Identifier NCT01970631 ; Registered 23 October 2013. [ABSTRACT FROM AUTHOR]

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المؤلفون: Hunter, David, Nevitt, Michael, Lynch, John, Kraus, Virginia Byers, Katz, Jeffrey N., Collins, Jamie E., Bowes, Mike, Guermazi, Ali, Roemer, Frank W., Losina, Elena, FNIH OA Biomarkers Consortium

المصدر: Annals of the Rheumatic Diseases; Sep2016, Vol. 75 Issue 9, p1607-1614, 8p, 1 Black and White Photograph, 1 Diagram, 4 Charts

مصطلحات موضوعية: COMPARATIVE studies, FEMUR, KNEE diseases, LONGITUDINAL method, MAGNETIC resonance imaging, RESEARCH methodology, MEDICAL cooperation, OSTEOARTHRITIS, PATELLA, RESEARCH, TIBIA, TIME, LOGISTIC regression analysis, EVALUATION research, CASE-control method, DISEASE progression, JOINT pain, DISEASE complications

مستخلص: Objective: To perform a longitudinal validation study of imaging bone biomarkers of knee osteoarthritis (OA) progression.Methods: We undertook a nested case-control study within the Osteoarthritis Initiative in knees (one knee per subject) with a Kellgren and Lawrence grade of 1-3. Cases were defined as knees having the combination of medial tibiofemoral radiographic progression and pain progression at the 24-month, 36-month or 48-month follow-up compared with baseline. Controls (n=406) were eligible knees that did not meet both endpoint criteria and included 200 with neither radiographic nor pain progression, 103 with radiographic progression only and 103 with pain progression only. Bone surfaces in medial and lateral femur, tibia and patella compartments were segmented from MR images using active appearance models. Independent variables of primary interest included change from baseline to 24 months in (1) total area of bone and (2) position on three-dimensional (3D) bone shape vectors that discriminate OA versus non-OA shapes. We assessed the association of bone markers changes over 24 months with progression using logistic regression.Results: 24-month changes in bone area and shape in all compartments were greater in cases than controls, with ORs of being a case per 1 SD increase in bone area ranging from 1.28 to 1.71 across compartments, and per 1 SD greater change in 3D shape vectors ranging from 1.22 to 1.64. Bone markers were associated most strongly with radiographic progression and only weakly with pain progression.Conclusions: In knees with mild-to-moderate radiographic OA, changes in bone area and shape over 24 months are associated with the combination of radiographic and pain progression over 48 months. This finding of association with longer term clinical outcome underscores their potential for being an efficacy of intervention biomarker in clinical trials. [ABSTRACT FROM AUTHOR]

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