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) ​≥ ​30 ​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.</p

Willingness of older adults to participate in a randomized trial of conservative therapies for knee pain: A prospective preference assessment

Background: In preparation for a trial of physical therapy (PT) for patients with degenerative meniscal tear and knee osteoarthritis, we conducted a prospective preference assessment -- a methodology for estimating the proportion of eligible subjects who would participate in a hypothetical randomized trial. Methods: We identified patients seeking care from the practices of five orthopedic surgeons. Patients completed a survey asking about their willingness to participate in a hypothetical trial, their treatment preferences, their knee pain, and demographic variables. Results: We approached 201 eligible patients, of whom 67% (95% confidence interval [CI] 60%, 73%) completed questionnaires. Of these, 24% (95% CI 17%, 31%) were definitely and 39% (95% CI 31%, 47%) were probably willing to participate in the trial. Thirty-three percent (95% CI 23%, 43%) of subjects with no treatment preference were definitely willing to participate as compared to 9% (95% CI 1%, 17%) with treatment preference (p = .001). Patients with higher educational attainment also stated a greater willingness to participate than those with less education (p = .06). In multivariable logistic regression analysis, those with no treatment preferences had greater adjusted odds of stating they would definitely participate than those with a defined treatment preference (OR 5.2, 95% CI 1.7, 16.2), while subjects with an associate's degree or greater were more likely to state they would definitely participate than those with less education (OR 3.9, 95% CI 1.1, 14.1). Conclusion: In this prospective preference assessment, 63% (95% CI 55%, 71%) of subjects with degenerative meniscal tear expressed willingness to participate in a trial of PT modalities. Individuals with no treatment preferences were more likely to state they would participate than were those with higher education. This methodology can help investigators estimate recruitment rates, anticipate generalizability of the trial sample and create strategies to facilitate enrollment

Activity Impairment and Work Productivity Loss After Total Knee Arthroplasty:A Prospective Study

BACKGROUND: Total knee arthroplasty (TKA) is increasingly performed among working-aged individuals, highlighting the importance of work-related outcomes. Therefore, the aim is to examine the extent of both activity impairment outside work and work productivity (absenteeism, presenteeism, at-work productivity loss) at 6 and 24 months post-TKA surgery. Additionally, associated risk factors with these outcomes were evaluated. METHODS: This analysis included 183 patients <70 years undergoing TKA who completed questionnaires pre-operatively and during follow-up. Outcomes were derived from the Work Productivity and Activity Impairment questionnaire and included activity impairment, absenteeism (sick leave), presenteeism (reduced work performance), and at-work productivity loss (overall work productivity loss). All outcomes were scaled 0%-100%, with higher percentages indicating higher impairments. Covariates included age, gender, education, pain catastrophizing, pain, function, psychological distress, and knee-related and health-related quality of life. Linear and logistic regression was used to assess associations between covariates and Work Productivity and Activity Impairment scores at follow-up. RESULTS: At 6 months, the mean activity impairment was 22.8% (standard deviation [SD] 23.5) dropping to 17.1% (23.1) by 24 months. Among workers, presenteeism was 18.4% (24.6) and at-work productivity loss was 20.8% (26.1). Both dropped significantly by 24 months to 14.2% (22.4) and 12.9% (20.9), respectively. Absenteeism levels were low at both time points. Pain catastrophizing was associated with all outcomes. CONCLUSION: This study showed that activity impairment and work productivity loss are common following TKA, decreased significantly over time, but still existed 2 years post-operatively. Those reporting high levels of pain catastrophizing may benefit from targeted rehabilitation guidance to reduce and possibly prevent activity impairment and work productivity loss