IMPORTANCE Approximately 3.4% of adults have ankle (tibiotalar) osteoarthritis and, among younger patients, ankle osteoarthritis is more common than knee and hip osteoarthritis. Few effective nonsurgical interventions exist, but platelet-rich plasma (PRP) injections are widely used, with some evidence of efficacy in knee osteoarthritis.OBJECTIVE To determine the effect of PRP injections on symptoms and function in patients with ankle osteoarthritis. DESIGN, SETTING, AND PARTICIPANTSA multicenter, block-randomized, double-blinded, placebo-controlled clinical trial performed at 6 sites in the Netherlands that included 100 patients with pain greater than 40 on a visual analog scale (range, 0-100) and tibiotalar joint space narrowing. Enrollment began on August 24, 2018, and follow-up was completed on December 3, 2020.INTERVENTIONS Patients were randomly assigned (1:1) to receive 2 ultrasonography-guided intra-articular injections of either PRP (n = 48) or placebo (saline; n = 52). MAIN OUTCOMES AND MEASURESThe primary outcome was the validated American Orthopaedic Foot and Ankle Society score (range, 0-100; higher scores indicate less pain and better function; minimal clinically important difference, 12 points) over 26 weeks. RESULTS Among 100 randomized patients (mean age, 56 years; 45 [45%] women), no patients were lost to follow-up for the primary outcome. Compared with baseline values, the mean American Orthopaedic Foot and Ankle Society score improved by 10 points in the PRP group (from 63 to 73 points [95% CI, 6-14]; P < .001) and 11 points in the placebo group (from 64 to 75 points [95% CI, 7-15]; P < .001). The adjusted between-group difference over 26 weeks was −1 ([95% CI, -6 to 3]; P = .56). One serious adverse event was reported in the placebo group, which was unrelated to the intervention; there were 13 other adverse events in the PRP group and 8 in the placebo group.CONCLUSIONS AND RELEVANCE Among patients with ankle osteoarthritis, intra-articular PRP injections, compared with placebo injections, did not significantly improve ankle symptoms and function over 26 weeks. The results of this study do not support the use of PRP injections for ankle osteoarthritis.
Objective Ankle osteoarthritis (OA) has a prevalence of 3.4% in the general population of which 70% to 78% is posttraumatic, affecting younger patients with a longer projected life span compared with hip and knee OA. The current literature reports the physical and mental quality of life (QoL) of patients with ankle OA, to be similar to end-stage hip OA, end-stage kidney disease and digestive heart failure. However, the QoL of ankle OA patients has not yet been determined compared with a matched control group representing the general population. Our aim is to determine the physical and mental QoL compared with a matched control group. Design The Physical and Mental Component Summaries of the Short Form–36 of 100 patients with ankle OA were compared with 91 age- and gender-matched controls. This case-control study is a substudy of the PRIMA trial, in which the efficacy of platelet-rich plasma injections for ankle OA is determined. Results A clinically relevant difference was found for both the Physical ( P=0.003; 95% CI −6.7 to −1.3) and Mental Component Summary scores ( P < 0.001; 95% CI −10 to −6). Patients with ankle OA had a median of 45 points (matched controls 52 points) and 43 points (matched controls 53 points) for the Physical and Mental Component summary scores, respectively. Conclusions Patients with ankle OA had a clinically relevant poorer mental and physical QoL compared with matched controls from the general population. Furthermore, the physical QoL of patients with ankle OA from younger age categories was affected more than those in older age categories.
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