Platelet-Rich plasma Injection Management for Ankle osteoarthritis study (PRIMA): protocol of a Dutch multicentre, stratified, block-randomised, double-blind, placebo-controlled trial

Abstract

IntroductionPlatelet-rich plasma (PRP) is a potentially efficacious treatment for ankle osteoarthritis (OA), but its use has not been examined in high-quality studies. Systematic reviews show that PRP injections significantly decrease pain and improve function in patients with knee OA. Ankle OA is more common than hip or knee OA in the young active population; with a prevalence of 3.4%.PRP injections in ankle OA are shown to be safe and improve quality of life over time, but no randomised controlled trial has been conducted. Our randomised controlled trial will evaluate the efficacy of PRP injections for symptom reduction and functional improvement, compared with placebo, in the treatment of ankle (talocrural) OA.Methods and analysisWe will conduct the Platelet-Rich plasma Injection Management for Ankle OA study: a multicentre, randomised, placebo-controlled trial. One hundred patients suffering from ankle OA will be randomised into two treatment groups: PRP injection or placebo (saline) injection. Both groups will receive two injections of PRP or placebo at an interval of 6 weeks. Primary outcome is the American Orthopaedic Foot and Ankle Society score at 26 weeks. Secondary outcomes determined at several follow-up moments up to 5 years, include Ankle Osteoarthritis Score, Foot and Ankle Outcome Score, pain subscale of (0–40), Visual Analogue Scale score (0–100), Ankle Activity Score (0–10), subjective patient satisfaction Short Form Health Survey-36, Global Attainment Scaling and the EuroQol-5 dimensions-3 levels utility score. A cost-effectiveness analysis will be performed at 1 year.Ethics and disseminationThe study is approved by the Medical Ethics Review Committee Amsterdam Medical Center, the Netherlands (ABR 2018–042, approved 23 July 2018) and registered in the Netherlands trial register (NTR7261). Results and new knowledge will be disseminated through the Dutch Arthritis Association (ReumaNederland), Dutch patient federation, conferences and published in a scientific peer-reviewed journal.Trial registration numberNTR7261.

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

“…The mean (SD) baseline AOFAS scores were 63 (13) in the PRP group and 64 (16) in the placebo group. Between baseline and 26-week follow-up, the mean AOFAS score improved by 10 points (95% CI, [6][7][8][9][10][11][12][13][14] in the PRP group compared with 11 points (95% CI, 7-15) in the placebo group (Table 2; Figure 2 and Figure 3).…”

“…Further details on baseline measurements, including radiological variables, are provided in eTables 1 and 2 in Supplement 2 and the published protocol. 13…”

“…[27][28][29] With a 2-sided significance level of 5%, 90% power, a dropout rate of 10%, and an expected SD of 16.3, a total of 50 patients per group were needed (100 in total). 13…”

Health-Related Quality of Life in Ankle Osteoarthritis: A Case-Control Study

“…It is a substudy of the PRIMA trial, a randomized, double-blind, placebo-controlled, multicenter prospective study, designed to determine the efficacy of platelet-rich plasma injections in the management of ankle OA. 16 We used baseline SF-36 patient data from the PRIMA trial and matched controls from a database of the general population. The PRIMA trial is approved by the Medical Ethics Review Committee Amsterdam Medical Center, the Netherlands (ABR 2018-042, approved July 23, 2018) and registered in the Netherlands trial register (NTR7261).…”

“…At baseline, before receiving the intervention of the PRIMA trial, the ankle OA patients completed the SF-36 questionnaire. 16 The SF-36 is validated in the Dutch language and consists of 8 subscales. 17 All (sub)scales and summary scores go from 0 to 100, where 0 represents low quality of life or function and 100 represents high quality of life or function.…”