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
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