A pilot randomised prospective comparison of two approaches for tibial nailing using clinical and novel imaging outcome measures - study protocol

Fractures of the tibia are frequently treated with an intra-medullary nail. This can be inserted through either a supra-patella or infra-patella surgical incision. Concerns over potential damage to the cartilage of the knee with supra-patella insertion has impacted upon its adoption despite benefits in terms of easier nail placement and potentially reduced blood loss and pain. This randomised pilot study will use patient reported outcome measures (PROMS) and novel MRI sequences designed to assess damage to the structure of cartilage to compare these two methods of tibial intra-medullary nailing. Twenty individuals with tibial shaft fractures will be randomised to either method of nail insertion (ten individuals in each arm). MRI scans and PROMS will be used to assess cartilage damage and general function up to 6 months post operatively. The results of the study will be used to inform a potential multi-centre study.