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

Pilot and Feasibility Studies

Caroline B. Hing¹  Alex Trompeter¹  Michael Law¹  Michael Pearse²  Matthew L. Costa³  Molly Glaze³  Jonathan Cook³  Elizabeth Tutton³  Emma Phelps³  Cushla Cooper³  Jamie R. Stokes³  Melina Dritsaki³  Toby O. Smith⁴ 

[1] Department of Trauma and Orthopaedics, St George’s University Hospitals NHS Foundation Trust, London, UK;Imperial College London, London, UK;Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK;Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK;Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, Norfolk, UK;

关键词: Equipoise;    Feasibility;    Randomised controlled trial;    Qualitative;    Interviews;    Survey;   

DOI  :  10.1186/s40814-021-00821-3

来源: Springer

【 摘 要 】

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

【 授权许可】

CC BY