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  • Intramedullary nails versus distal locking plates for fracture of the distal femur: results from the Trial of Acute Femoral Fracture Fixation (TrAFFix) randomised feasibility study and process evaluation

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Surgery
Research
Intramedullary nails versus distal locking plates for fracture of the distal femur: results from the Trial of Acute Femoral Fracture Fixation (TrAFFix) randomised feasibility study and process evaluation
  1. Xavier L Griffin1,2,
  2. Matthew L Costa1,2,
  3. Emma Phelps1,
  4. Nicholas Parsons3,
  5. Melina Dritsaki4,
  6. Juul Achten1,
  7. Elizabeth Tutton2,5,
  8. Robin Gillmore Lerner6,
  9. Alwin McGibbon7,
  10. Janis Baird8,9
  11. TraFFix study collaborators
    1. 1 Oxford Trauma, University of Oxford Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, Oxford, UK
    2. 2 Oxford University Hospitals NHS Foundation Trust, Oxford, UK
    3. 3 Statistics and Epidemiology Unit, University of Warwick, Coventry, UK
    4. 4 Oxford Clinical Trials Research Unit, University of Oxford Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, Oxford, UK
    5. 5 Warwick Medical School, University of Warwick, Coventry, UK
    6. 6 Kadoorie Centre, University of Oxford Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, Oxford, UK
    7. 7 Patient and Public Representative, Coventry, UK
    8. 8 MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK
    9. 9 NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK
    1. Correspondence to Dr Xavier L Griffin; xavier.griffin{at}ndorms.ox.ac.uk

    Abstract

    Objectives This feasibility study and process evaluation assessed the likely success of a definitive trial of intramedullary fixation with locked retrograde nails versus extramedullary fixation with fixed angle plates for fractures of the distal femur.

    Design & setting A multicentre, parallel, two-arm, randomised controlled feasibility study with an embedded process evaluation was conducted at seven NHS hospitals in England. Treatment was randomly allocated in 1:1 ratio, stratified by centre and chronic cognitive impairment. Participants, but not surgeons or research staff, were blinded to the allocation.

    Participants Patients 18 years and older with a fracture of the distal femur, who their surgeon believed would benefit from internal fixation, were eligible to take part.Participants were allocated to receive either a retrograde intramedullary nail or an anatomical locking plate.

    Outcomes The primary outcomes for this feasibility study were the recruitment rate and completion rate of the EQ-5D-5L at 4 months post-randomisation. Baseline characteristics, disability rating index, quality of life scores, measurements of social support and self-efficacy, resource use and radiographic assessments were also collected. The views of patients and staff were collected during interviews.

    Results Recruitment and data completion were lower than expected. 23 of 82 eligible patients were recruited (nail, 11; plate, 12). The recruitment rate was estimated as 0.42 (95% CI 0.27 to 0.62) participants per centre-month. Data completeness of the EQ-5D-5L at 4 months was 61 per cent (95% CI 43% to 83%). The process evaluation demonstrated that the main barriers to recruitment were variation in treatment pathways across centres, lack of surgeon equipoise and confidence in using both interventions and newly formed research cultures that lacked cohesion.

    Conclusions A modified trial design, with embedded recruitment support intervention, comparing functional outcome in cognitively intact adults who have sustained a fragility fracture of the distal femur is feasible.

    Ethics approval The Wales Research Ethics Committee 5 approved the study (ref: 16/WA/0225).

    Trial registration number ISRCTN92089567; Pre-results.

    • clinical trials
    • fractures, bone
    • fracture fixation, internal
    • randomized controlled trial
    • feasibility studies
    • femoral fractures

    This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

    https://doi.org/10.1136/bmjopen-2018-026810

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      Footnotes

      • Contributors XLG (Associate Professor of Trauma Surgery) contributed to the conception, design, conduct and reporting of the study. MLC (Professor of Orthopaedic Trauma Surgery) contributed to the conception, design and reporting of the study. EP (Postdoctoral Research Associate in Mixed Methods Research) contributed to the design, conduct and analysis of the process evaluation and the reporting of the study. NP (Associate Professor of Medical Statistics, Statistics and Epidemiology) contributed to the design, conduct, analysis and reporting of the study. MD (Senior Health Economist) contributed to the design and conduct of the study. JA (Scientific Officer Oxford Trauma) contributed to the conception, design, conduct and reporting of the study. ET (Senior Research Fellow) contributed to the design, conduct and analysis of the process evaluation and the reporting of the study. RL (Clinical Trial Manager) contributed to the conduct and reporting of the study. AMG (Patient & Public Representative) contributed to the design, conduct and reporting of the study. JB (Professor of Public Health and Epidemiology) contributed to the conception, design, conduct, reporting and analysis of the study.

      • Funding This project was funded by the Health Technology Assessment programme (HTA) (project number 15/59/22) and will be published in full in the NIHR HTA Journal. Further information available at: https://www.journalslibrary.nihr.ac.uk/programmes/hta/155922/#/. This work was also supported by NIHR Oxford Biomedical Research Centre.

      • Competing interests Matthew Costa is a member of the UK NIHR HTA General Board. Janis Baird received funding from Danone Nutrica Early Life Nutrition for a specific research study which aims to improve the nutrition and Vitamin D status of pregnant women and is collaborating with Iceland Foods Ltd to evaluate the impact fruit and vegetable availability on diet.

      • Provenance and peer review Not commissioned; externally peer reviewed.

      • Data sharing statement All data requests should be submitted to the corresponding author for consideration. Please note exclusive use will be retained until the publication of major outputs. Access to anonymised data may be granted following review.

      • Collaborators Mr David Noyes, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust. Professor Peter Giannoudis, Leeds General Infirmary, The Leeds Teaching Hospitals NHS Trust. Professor Ben Ollivere, Queen’s Medical Centre, Nottingham University Hospitals NHS Trust. Ms Charlotte Lewis, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust. Mr Haroon Majeed, Mr Damian McClelland, Royal Stoke Hospital, University Hospitals of North Midlands NHS Trust. Mr Ashwin Kulkarni, Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust.

      • Patient consent for publication Not required.