Z Little1, T O Smith2, S E McMahon3, C Cooper4, A Trompeter5, M Pearse6, S Britten7, B Rogers8, H Sharma9, B Narayan10, M Costa11, D J Beard12, C B Hing13. 1. ST5 Trauma and Orthopaedics, St Helier Hospital, Wrythe Lane, Carshalton, SM5 1AA, United Kingdom. Electronic address: Zoe.little@doctors.org.uk. 2. Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, United Kingdom. Electronic address: toby.smith@uea.ac.uk. 3. Royal Victoria Hospital, Belfast, BT12 6BA, United Kingdom. Electronic address: Sammc84@googlemail.com. 4. RCS Surgical Intervention Trials Unit, NDORMS, University of Oxford, United Kingdom. Electronic address: Cushla.cooper@ndorms.ox.ac.uk. 5. Department of Trauma and Orthopaedics, St George's Hospital, Tooting, London, SW17 0QT, United Kingdom. Electronic address: Alex.trompeter@stgeorges.nhs.uk. 6. St Mary's Hospital, Praed Street, London, W2 1NY, United Kingdom. Electronic address: M.pearse@imperial.ac.uk. 7. Leeds Teaching Hospitals NHS Trust, West Yorkshire, LS13EX, United Kingdom. Electronic address: Simon.britten@leedsth.nhs.uk. 8. Brighton & Sussex University Hospitals NHS Trust, United Kingdom. Electronic address: Benedict.Rogers@bsuh.nhs.uk. 9. Hull and East Yorkshire NHS Hospitals Trust, Hull, HU3 2JZ, United Kingdom. Electronic address: hksorth@yahoo.co.uk. 10. Royal Liverpool and Broadgreen Hospitals, Prescot Street, Liverpool, L7 8XP, United Kingdom. Electronic address: emailbadri@gmail.com. 11. University of Oxford, Oxford Trauma, The Kadoorie Centre, John Radcliffe Hospital, Oxford, OX3 9DU, United Kingdom. Electronic address: matthew.costa@ndorms.ox.ac.uk. 12. Surgical Intervention Trials Unit (SITU), Nuffield Dept. of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, United Kingdom. Electronic address: david.beard@ndorms.ox.ac.uk. 13. Department of Trauma and Orthopaedics, St George's Hospital, Tooting, London, SW17 0QT, United Kingdom. Electronic address: caroline.hing@stgeorges.nhs.uk.
Abstract
INTRODUCTION:Segmental tibial fractures are complex injuries with a prolonged recovery time. Current definitive treatment options include intramedullary fixation or a circular external fixator. However, there is uncertainty as to which surgical option is preferable and there are no sufficiently rigorous multi-centre trials that have answered this question. The objective of this study was to determine whether patient and surgeon opinion was permissive for a randomised controlled trial (RCT) comparing intramedullary nailing to the application of a circular external fixator. MATERIALS AND METHODS: A convenience questionnaire survey of attending surgeons was conducted during the United Kingdom's Orthopaedic Trauma Society annual meeting 2017 to determine the treatment modalities used for a segmental tibial fracture (n=63). Patient opinion was obtained from clinical patients who had been treated for a segmental tibial fracture as part of a patient and public involvement focus group with questions covering the domains of surgical preference, treatment expectations, outcome, the consent process and follow-up regime (n=5). RESULTS: Based on the surgeon survey, 39% routinely use circular frame fixation following segmental tibial fracture compared to 61% who use nail fixation. Nail fixation was reported as the treatment of choice for a closed injury in a healthy patient in 81% of surgeons, and by 86% for a patient with a closed fracture who was obese. Twenty-one percent reported that they would use a nail for an open segmental tibia fracture in diabetics who smoked, whilst 57% would opt for a nail for a closed injury with compartment syndrome, and only 27% would use a nail for an open segmental injury in a young fit sports person. The patient and public preference exercise identified that sleep, early functional outcomes and psychosocial measures of outcomes are important. CONCLUSION: We concluded that a RCT comparing definitive fixation with an intramedullary nail and a circular external fixator is justified as there remains uncertainty on the optimal surgical management for segmental tibial fractures. Furthermore, psychosocial factors and early post-operative outcomes should be reported as core outcome measures as part of such a trial.
RCT Entities:
INTRODUCTION: Segmental tibial fractures are complex injuries with a prolonged recovery time. Current definitive treatment options include intramedullary fixation or a circular external fixator. However, there is uncertainty as to which surgical option is preferable and there are no sufficiently rigorous multi-centre trials that have answered this question. The objective of this study was to determine whether patient and surgeon opinion was permissive for a randomised controlled trial (RCT) comparing intramedullary nailing to the application of a circular external fixator. MATERIALS AND METHODS: A convenience questionnaire survey of attending surgeons was conducted during the United Kingdom's Orthopaedic Trauma Society annual meeting 2017 to determine the treatment modalities used for a segmental tibial fracture (n=63). Patient opinion was obtained from clinical patients who had been treated for a segmental tibial fracture as part of a patient and public involvement focus group with questions covering the domains of surgical preference, treatment expectations, outcome, the consent process and follow-up regime (n=5). RESULTS: Based on the surgeon survey, 39% routinely use circular frame fixation following segmental tibial fracture compared to 61% who use nail fixation. Nail fixation was reported as the treatment of choice for a closed injury in a healthy patient in 81% of surgeons, and by 86% for a patient with a closed fracture who was obese. Twenty-one percent reported that they would use a nail for an open segmental tibia fracture in diabetics who smoked, whilst 57% would opt for a nail for a closed injury with compartment syndrome, and only 27% would use a nail for an open segmental injury in a young fit sports person. The patient and public preference exercise identified that sleep, early functional outcomes and psychosocial measures of outcomes are important. CONCLUSION: We concluded that a RCT comparing definitive fixation with an intramedullary nail and a circular external fixator is justified as there remains uncertainty on the optimal surgical management for segmental tibial fractures. Furthermore, psychosocial factors and early post-operative outcomes should be reported as core outcome measures as part of such a trial.
Authors: Caroline B Hing; Elizabeth Tutton; Toby O Smith; Molly Glaze; Jamie R Law; Jonathan Cook; Melina Dritsaki; Emma Phelps; Cushla Cooper; Alex Trompeter; Michael Pearse; Michael Law; Matthew L Costa Journal: Pilot Feasibility Stud Date: 2021-04-10