To determine whether platelet-rich plasma (PRP) injection improves outcomes two years after acute Achilles tendon rupture. A randomized multicentre two-arm parallel-group, participant- and assessor-blinded superiority trial was undertaken. Recruitment commenced on 28 July 2015 and two-year follow-up was completed in 21 October 2019. Participants were 230 adults aged 18 years and over, with acute Achilles tendon rupture managed with non-surgical treatment from 19 UK hospitals. Exclusions were insertion or musculotendinous junction injuries, major leg injury or deformity, diabetes, platelet or haematological disorder, medication with systemic corticosteroids, anticoagulation therapy treatment, and other contraindicating conditions. Participants were randomized via a central online system 1:1 to PRP or placebo injection. The main outcome measure was Achilles Tendon Rupture Score (ATRS) at two years via postal questionnaire. Other outcomes were pain, recovery goal attainment, and quality of life. Analysis was by intention-to-treat.Aims
Methods
Regenerative medicine is a rapidly expanding discipline. However due to a lack of validated outcome measures, clinical trials have been far few. This study aims to assess the validity, inter-observer reliability and intra-observer reproducibility of experimental fracture healing assessment on plain radiographies. This technique involves implantation of mesenchymal stem cell (MSC) seeded constructs on only one side of the fracture after randomisation. We examined inter/intraobserver agreement on the area and “bridging length” of callus formed on opposite sides of the fracture. Among 16 orthopaedic surgeons with trauma commitments (8 consultants, 8 registrars) on two separate occasions (average 52 days apart). They independently assessed the radiographs (AP or lateral) of 28 patients with fractures of the tibial or femoral shaft. The fractures chosen included non-unions treated with MSC/constructs and fresh fractures at 4–9 months. For each radiograph the assessor assigned which side (medial or lateral) is there more callus. Chase-corrected agreement using Fleiss kappa was used to compare opinions. Digital analysis software (Image-J) was used to quantify extent/bridging callus and correlate it with surgeons opinion.Introduction
Methods
