Reamed intramedullary nailing versus circular frame external fixation for segmental tibial fractures (STIFF-F): a mixed methods feasibility study

Abstract Background Segmental tibial fractures are in two or more areas of the diaphysis resulting a separate intercalary segment bone. Surgical fixation is recommended for patients with segmental as non-operative treatment outcomes poor. The most common surgical interventions intramedullary nailing (IMN) and circular frame external (CFEF), but evidence about which better poor quality. An adequately powered randomised controlled trial (RCT) to determine optimum required. STIFF-F aimed assess feasibility multicentre RCT comparing IMN CFEF fracture. Methods was mixed-methods study comprising pilot conducted at six UK Major Trauma Centres, qualitative interviews drawing on Phenomenology an online survey rehabilitation. primary outcome recruitment rate. Patients, 16 years over, fracture (open closed) deemed suitable were eligible participate. Randomisation stratified by site using random permuted blocks varying sizes. Participant assessor blinding not possible. Interviews undertaken their experience injury, treatment, recovery participation. Staff interviewed identify contextual factors affecting processes, pathway. developed understand rehabilitation context treatments. Results Eleven screened three recruited RCT. Nineteen staff four participated interviews, 11 physiotherapists responded survey. This found following: (i) rarer than anticipated, (ii) complexity setup times surgeon preferences impeded recruitment, (iii) from challenging, protocols inconsistent (iv) despite difficulty recruiting, valued this research question strived find way forward. Conclusion proposed feasible. highlighted recruiting complex rare injury over short time period. Trial registration registered International Standard Randomised Controlled Trials Number Registry: ISRCTN11229660