PATH-2 is a pragmatic multi-centre, blinded, randomised placebo-controlled trial comparing Platelet Rich Plasma injection (PRP) to placebo (imitation) injection in adults with Achilles tendon rupture (ATR). Two sub-studies are embedded within the main study to contribute to the understanding of the PRP mechanism in tendon healing.
The study has been designed to evaluate the clinical efficacy of Platelet Rich Plasma in acute Achilles tendon rupture in terms of mechanical muscle-tendon function.
214 patients will be recruited to be randomly allocated to receive either:
PRP injection into the ATR gap or an imitation (placebo) injection.
A cast is the current standard treatment.
The patient will receive the study/placebo treatment and will then participate in telephone follow-ups at weeks 4, 7 and 13 and attend for a 24 week follow-up in clinic, arranged by the recruiting site. The primary outcome is a Heel-rise Endurance Test at the 24 week follow-up appointment in clinic.
Patients will be identified in the outpatient trauma/orthopaedic clinic in 15 hospitals across the UK. Recruitment started in spring 2015 and will continue for 20 months. It is anticipated that each site will recruit a minimum of 1 patient per month.
PATH-2 is an academic clinical research study sponsored by Oxford University and is led by Professor Keith Willett, Professor of Orthopaedic Trauma Surgery. Project funding was awarded by the Efficacy and Mechanism Evaluation (EME) Programme and is funded by the Medical Research Council (MRC) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC-NIHR partnership.
Updates on the progress of the trial and other information can be found on the main trial website