Platelet Rich Plasma in Achilles Tendon Healing (PATH-2) Trial: Protocol for a multi-centre, participant and assessor-blinded, parallel-group randomised clinical trial comparing Platelet Rich Plasma (PRP) injection versus placebo injection for Achilles tendon rupture

Joseph Alsousou, David Keene, Philippa Hulley, Paul Harrison, Susan Wagland, Christopher Byrne, Michael Schlüssel, Susan Dutton, Sarah Lamb, Keith Willett

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12 Citations (Scopus)
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Abstract

Background
Achilles tendon injuries give rise to substantial long-lasting morbidity and pose considerable challenges for clinicians and patients, especially during the lengthy healing and recovery period. Current treatment strategies struggle to curb the burden of this injury on health systems and societal cost due to lengthy rehabilitation, absence from work and the risk of re-injury. Platelet Rich Plasma (PRP) is an autologous preparation that has been shown to improve the mechanobiological properties of tendons in laboratory and animal studies. The use of PRP in musculoskeletal injuries is on the increase despite the lack of adequately powered clinical studies.
Methods and Design
We aim to undertake a multi-centre randomised controlled trial to evaluate the efficacy and mechanism of PRP in patients with acute Achilles tendon rupture. All adult patients with acute Achilles tendon rupture presenting within 12 days of the injury that are to be treated non-operatively are potentially eligible to take part. A total of 214 consenting patients will be randomly allocated (1:1) via a remote web-based randomisation service to receive either PRP injection or placebo (imitation) injection to the site of the injury. All participants will be blinded to the intervention and will receive standardised rehabilitation to reduce the risk of efficacy interference from substantial variation in rehabilitation.
Participants will be followed up with blinded assessments of muscle-tendon function, quality of life, pain and overall patient’s functional goals at 4, 7, 13, 24 weeks and 24 months post treatment. The primary outcome is the heel rise endurance test (HRET), which will be supervised by a blinded assessor at 24 weeks. A subgroup of 16 participants in one centre will have needle biopsy under ultrasound guidance at 6 weeks. Blood and PRP will be analysed for cell count, platelet activation and growth factors concentration.
Discussion
This article presents the protocol for a multi-centre randomised controlled trial that is currently recruiting. It gives details of methods and describes the key procedures taken to avoid bias and to ensure validity.
Original languageEnglish
Number of pages21
JournalBMJ open
DOIs
Publication statusPublished - 1 Nov 2017

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