Infection and Non-Union Rates Following Osteosynthesis of Long Bone Fractures Using Locally Manufactured Versus Imported Implants in Selected Nigerian Centres

The high cost of imported orthopaedic implants in Nigeria has driven interest in locally manufactured alternatives, but rigorous comparative evidence on their clinical performance remains scarce. This multicentre retrospective cohort study compares infection rates and non-union rates following osteosynthesis of long bone fractures using locally manufactured and imported implants across four orthopaedic centres in Lagos, Enugu, Kano, and Abuja. Over a five-year period, case records of adult patients who underwent surgical fixation of femoral, tibial, or humeral shaft fractures will be reviewed. Outcomes at six and twelve months will include surgical site infection, chronic osteomyelitis, radiological non-union, implant failure, and re-operation rates. Propensity score matching will be applied to control for baseline differences in fracture severity and patient characteristics between implant groups. Meta-regression will assess whether outcomes differ systematically by implant category after adjustment. The study hypothesises that locally manufactured implants demonstrate significantly higher rates of implant failure but comparable infection rates to imported counterparts. Findings will be submitted to the Standards Organisation of Nigeria (SON) and the Nigerian Orthopaedic Association to inform implant quality standards and procurement policy. Keywords: osteosynthesis, implant quality, non-union, infection rates, local manufacturing.