The PATH-2 trial found no evidence of a benefit of Platelet Rich Plasma (PRP) injection versus a placebo after Achilles tendon rupture (ATR) at six-months. ATR often leave longer-term functional deficiencies beyond six-months. This study aim is to determine if PRP affect tendon functional outcomes at two-years after rupture. Randomised multi-centre two-arm parallel-group, participant- and assessor-blinded, superiority trial.Background
Study design
Following publication of the Ankle Injury Management (AIM) trial in 2016 which compared the management of ankle fractures with open reduction and internal fixation (ORIF) versus closed contact casting (CCC), we looked at how the results of this study have been adopted into practice in a trauma unit in the United Kingdom. Institutional approval granted to identify eligible patients from a trauma database. 143 patients over 60 years with an unstable ankle fracture between 2017 and 2019 (1 year following publication of the AIM trial) were included. Open fractures, and patients with insulin-dependent diabetes or peripheral vessel disease were excluded (as per AIM criteria). Radiographs were reviewed for malunion and non-union. Clinical notes were reviewed for adverse events. Minimum follow up was 24 months.Introduction
Methods
Disability and slow return to sport and work after tendon rupture are major challenges. Platelet Rich Plasma (PRP) is an autologous supraphysiological concentration of platelets from whole blood that has demonstrated positive cellular and physiological effects on healing in laboratory conditions but evidence from adequately powered robust clinical trials is lacking. We aimed to determine the clinical efficacy of PRP for treatment of acute Achilles tendon rupture. In a placebo-controlled, participant- and assessor-blinded, trial at 19 NHS hospitals we randomly assigned 230 adults starting acute Achilles rupture non-surgical management to PRP injection or dry-needle insertion (placebo) to the rupture gap under local anaesthetic. Patients with confounding or contraindicated concurrent medical conditions were excluded. The primary outcome was muscle-tendon function, assessed by the limb symmetry index (LSI, uninjured limb/injured limb × 100, higher scores better) of the work (Joules) performed during the heel-rise endurance test at 24 weeks. Secondary outcomes were: Achilles Tendon Rupture Score (ATRS, 0–100, higher scores better), quality of life (SF-12), pain, and goal attainment. Trial registration: ISRCTN54992179Background
Methods
