Journal Article

Platelet rich plasma injection for acute Achilles tendon rupture: PATH-2 randomised, placebo controlled, superiority trial

Hulley, Philippa, O’Connor, Heather M, Willett, Keith, Wagland, Susan, Alsousou, Joseph, Schlüssel, Michael Maia, Dutton, Susan J, Lamb, Sarah E, Harrison, Paul, Parsons, Scott R, Thompson, Jacqueline Y, Keene, David J

2019

Overview

AbstractObjectiveTo determine whether an injection of platelet rich plasma improves outcomes after acute Achilles tendon rupture.DesignRandomised, placebo controlled, two arm, parallel group, participant and assessor masked, superiority trial.SettingSecondary care trauma units across 19 hospitals in the United Kingdom’s health service.ParticipantsRecruitment commenced in July 2015 and follow-up was completed in March 2018. 230 adults aged 18 years and over were included, with acute Achilles tendon rupture presenting within 12 days of injury and managed with non-surgical treatment. Exclusions were injury at the insertion or musculotendinous junction, major leg injury or deformity, diabetes mellitus, platelet or haematological disorder, systemic corticosteroids, anticoagulation treatment, and other contraindicating conditions.InterventionsParticipants were randomised 1:1 to platelet rich plasma (n=114) or placebo (dry needle; n=116) injection. All participants received standard rehabilitation care (ankle immobilisation followed by physiotherapy).Main outcomes and measuresPrimary outcome was muscle tendon function at 24 weeks, measured objectively with the limb symmetry index (injured/uninjured×100) in maximal work done during the heel rise endurance test (an instrumented measure of repeated single leg heel rises until fatigue). Secondary outcomes included patient reported function (Achilles tendon rupture score), quality of life (short form 12 version 2®), pain (visual analogue scale), goal attainment (patient specific functional scale), and adverse events. A central laboratory analysed the quality and content of platelet rich plasma. Analyses were by modified intention to treat.ResultsParticipants were 46 years old on average, and 57 (25%) of 230 were female. At 24 weeks, 202 (88%) participants completed the heel rise endurance test and 216 (94%) the patient reported outcomes. The platelet rich plasma was of good quality, with expected growth factor content. No difference was detected in muscle tendon function between participants receiving platelet rich plasma injections and those receiving placebo injections (limb symmetry index, mean 34.7% (standard deviation 17.7%) v 38.5% (22.8%); adjusted mean difference −3.9% (95% confidence interval −10.5% to 2.7%)) or in any secondary outcomes or adverse event rates. Complier average causal effect analyses gave similar findings.ConclusionsThere is no evidence to indicate that injections of platelet rich plasma can improve objective muscle tendon function, patient reported function, or quality of life after acute Achilles tendon rupture compared with placebo, or that they offer any patient benefit.Trial registrationISRCTN54992179.

• Publisher: British Medical Journal Publishing Group,BMJ Publishing Group LTD,BMJ Publishing Group Ltd
• Subject: Achilles tendon / Achilles Tendon - injuries / Adult / Age / Ankle / Arthritis / Blood platelets / Clinical trials / Conservative Treatment - methods / Corticosteroids / Diabetes mellitus / Female / Growth factors / Humans / Immobilization / Injection / Injections - methods / Injuries / Laboratories / Leg / Male / Middle Aged / Pain / Patient Reported Outcome Measures / Patients / Platelet-Rich Plasma / Platelets / Quality control / Quality of Life / Questionnaires / Recovery of Function / Rehabilitation / Rupture / Systematic review / Tendon Injuries - diagnosis / Tendon Injuries - physiopathology / Tendon Injuries - psychology / Tendon Injuries - therapy / Tendons / Trauma / Treatment Outcome / United Kingdom