Effect of Platelet-Rich Plasma Injections vs Placebo on Ankle Symptoms and Function in Patients With Ankle Osteoarthritis

Abstract

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.

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“… 53 Interestingly, among patients with ankle OA, USG intra-articular PRP injection was akin USG placebo injection as regards pain and disability. 54 US guided injection of the talonavicular joint is better compared to a LMB method. 55 US guided posterior subtalar joint injections allow easy and precise needle insertion while reducing the risk of damaging nearby vital soft-tissues structures un-noticed by other procedures such as fluoroscopy or CT. 56 However, LMB approach is as effective as US-guidance for intra-articular injection in patients with hallux rigidus.…”

Foot & Ankle

“…Growth factors in platelet-rich plasma (PRP) can have an anti-inflammatory and analgesic effect when injected intra-articularly, as demonstrated in knee arthritis, but evidence in ankle arthritis from randomized trials do not exist. This study from Amsterdam (The Netherlands) therefore assessed the efficacy of PRP injections in ankle arthritis in a multicentre, randomized, double-blinded, placebo-controlled clinical trial 5. Patients were eligible for inclusion if they were aged 18 years or older, had a score of at least 40 for ankle osteoarthritis (OA) pain severity on a visual analogue scale(VAS; range 0 to 100, with higher scores indicating more severe pain) during daily activities, and had radiological imaging indicating ankle arthritis at least grade 2 on the van Dijk classification (with grade 2 being joint space narrowing with or without osteophytes; and grade 3 being (sub)total disappearance or deformation of the joint space).…”

Product characteristics should be reported in all biological therapy publications

“…There have been several recently published negative clinical trials of platelet-rich plasma (PRP) for the treatment of degenerative musculoskeletal conditions. Two of these, Effect of Intra-articular Platelet-Rich Plasma vs Placebo Injection on Pain and Medial Tibial Cartilage Volume in Patients with Knee Osteoarthritis: The RESTORE Randomized Clinical Trial by Bennell et al 1 and Effect of Platelet-Rich Plasma Injections vs Placebo on Ankle Symptoms and Function in Patients with Ankle Osteoarthritis: A Randomized Clinical Trial by Paget et al 2 are notable for more than their negative clinical outcomes.…”

“…The mean platelet count for PRP treatments was within physiological range at 325x10 ∧ 9/L; this platelet concentration does not meet many commonly accepted definitions for PRP (often defined as 3–5 × that of physiological platelet count or over 1000x10 ∧ 9/L platelets/mm 3. In Paget et al , 100 patients with mild to moderate ankle OA were randomised to two injections of PRP versus saline control 2. Likewise, this trial did not show significant benefits of the intervention arm.…”

“…Further, these data are not available in the supplemental materials and it is unclear to the reader if product characteristics were measured. In prior publications, the PRP processing device used in Paget et al has produced lower platelet count products 2…”