Retrograde intramedullary nail fixation compared with fixed-angle plate fixation for fracture of the distal femur: the TrAFFix feasibility RCT.
FEASIBILITY STUDIES
FEMORAL FRACTURES
FEMUR
FRACTURE FIXATION, INTERNAL
FRACTURES, BONE
RANDOMISED CONTROLLED TRIAL
Journal
Health technology assessment (Winchester, England)
ISSN: 2046-4924
Titre abrégé: Health Technol Assess
Pays: England
ID NLM: 9706284
Informations de publication
Date de publication:
09 2019
09 2019
Historique:
entrez:
25
9
2019
pubmed:
25
9
2019
medline:
3
10
2020
Statut:
ppublish
Résumé
Fractures of the distal femur are an increasingly common injury; the optimal management of these injuries remains controversial. The two interventions used in UK practice are intramedullary fixation, with a locked retrograde nail, and extramedullary fixation, with a fixed angle plate. This study assessed the feasibility of a definitive trial and included a process evaluation to understand the generalisability and likely success of a future trial. A multicentre, parallel, two-arm, randomised controlled feasibility trial with an embedded process evaluation. Treatment with a plate or nail was allocated in a 1 : 1 ratio, stratified by centre and chronic cognitive impairment. Surgeons were not blinded, but participants were not told their allocation. Seven NHS hospitals. Patients aged ≥ 18 years with a fracture of the distal femur who the attending surgeon believed would benefit from internal fixation were potentially eligible. Patients were excluded if they had a loose arthroplasty requiring revision or a femoral deformity or arthroplasty that precluded nail fixation. The sample was recruited between 29 September 2016 and 31 August 2017. Consent was obtained from the patient or appropriate consultee before enrolment. Patients were randomised to receive fixation of their distal femur fracture with either a proximally and distally locked retrograde nail that spanned the diaphysis of the femur or an anatomical distal femoral locking plate with at least one locked screw distal to the fracture. Reduction and supplemental fixation were at the surgeon's discretion. The primary outcome measures for this study were the recruitment rate and the completion rate of the EuroQol-5 Dimensions, five-level version (EQ-5D-5L), at 6 weeks and 4 months. Additional measurements included baseline characteristics, measures of social support and self-efficacy, disability rating index, dementia quality-of-life measures and a radiographical assessment of any malunion. Participants' and staff views were obtained, at interview, for the process evaluation. The process evaluation showed that surgeon-related factors, principally confidence with both technologies and a lack of individual equipoise, were key barriers to recruitment. A total of 23 participants were randomised and analysed (nail, This feasibility study has challenged many of the assumptions that underpinned the development of proposed definitive trial protocol. A modified protocol is proposed that would be feasible given the recruitment rate observed here, which is equal to that reported in the similar FixDT trial [Health Technology Assessment (HTA) 11/136/04: Costa ML, Achten J, Hennings S, Boota N, Griffin J, Petrou S, A definitive trial with a modified design is recommended, including an internal pilot to confirm initial recruitment rate assumptions. Current Controlled Trials ISRCTN92089567. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Breaks of the lower end of the thigh bone are increasingly common injuries. Two operations are used to treat these injuries: a rod placed along the centre of the bone or a plate attached to the edge of the bone. It is not clear which is better. We report the results from a study that will help develop the design of a definitive study to test which operation produces the best outcomes for patients. Adult patients with a break at the end of the thigh bone treated in one of seven hospitals were eligible to take part in the study. Participants were treated with one of two operations; the choice was made by chance using a computer program. Participants’ basic information and pre-injury health status were recorded and participants were followed up at 6 and 16 weeks. We assessed the rate at which participants agreed to take part in the study and the number who completed follow-up. A value-for-money analysis was performed to determine how to plan this element of a future study. Staff and patients were interviewed about the study processes and the context of the treatments and hospitals to understand how the treatments work and the practicalities of delivering the study. Lower than expected numbers of participants took part in the study; 173 patients were considered for the study, but only 23 agreed to participate. The main reason was that several of the participating surgeons felt strongly that one or the other operation was superior. The rate of follow-up was similar to that of other studies using these treatments. Therefore, the proposed definitive trial is unlikely to be successful if designed in the same way as this feasibility study. Several important considerations that informed the planning of this study were found not to hold true. We believe a modified study could be delivered and could answer this important research question.
Sections du résumé
BACKGROUND
Fractures of the distal femur are an increasingly common injury; the optimal management of these injuries remains controversial. The two interventions used in UK practice are intramedullary fixation, with a locked retrograde nail, and extramedullary fixation, with a fixed angle plate.
OBJECTIVES
This study assessed the feasibility of a definitive trial and included a process evaluation to understand the generalisability and likely success of a future trial.
DESIGN
A multicentre, parallel, two-arm, randomised controlled feasibility trial with an embedded process evaluation. Treatment with a plate or nail was allocated in a 1 : 1 ratio, stratified by centre and chronic cognitive impairment. Surgeons were not blinded, but participants were not told their allocation.
SETTING
Seven NHS hospitals.
PARTICIPANTS
Patients aged ≥ 18 years with a fracture of the distal femur who the attending surgeon believed would benefit from internal fixation were potentially eligible. Patients were excluded if they had a loose arthroplasty requiring revision or a femoral deformity or arthroplasty that precluded nail fixation. The sample was recruited between 29 September 2016 and 31 August 2017. Consent was obtained from the patient or appropriate consultee before enrolment.
INTERVENTIONS
Patients were randomised to receive fixation of their distal femur fracture with either a proximally and distally locked retrograde nail that spanned the diaphysis of the femur or an anatomical distal femoral locking plate with at least one locked screw distal to the fracture. Reduction and supplemental fixation were at the surgeon's discretion.
OUTCOMES
The primary outcome measures for this study were the recruitment rate and the completion rate of the EuroQol-5 Dimensions, five-level version (EQ-5D-5L), at 6 weeks and 4 months. Additional measurements included baseline characteristics, measures of social support and self-efficacy, disability rating index, dementia quality-of-life measures and a radiographical assessment of any malunion. Participants' and staff views were obtained, at interview, for the process evaluation.
RESULTS
The process evaluation showed that surgeon-related factors, principally confidence with both technologies and a lack of individual equipoise, were key barriers to recruitment. A total of 23 participants were randomised and analysed (nail,
CONCLUSIONS
This feasibility study has challenged many of the assumptions that underpinned the development of proposed definitive trial protocol. A modified protocol is proposed that would be feasible given the recruitment rate observed here, which is equal to that reported in the similar FixDT trial [Health Technology Assessment (HTA) 11/136/04: Costa ML, Achten J, Hennings S, Boota N, Griffin J, Petrou S,
FUTURE WORK
A definitive trial with a modified design is recommended, including an internal pilot to confirm initial recruitment rate assumptions.
REGISTRATION
Current Controlled Trials ISRCTN92089567.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in
Breaks of the lower end of the thigh bone are increasingly common injuries. Two operations are used to treat these injuries: a rod placed along the centre of the bone or a plate attached to the edge of the bone. It is not clear which is better. We report the results from a study that will help develop the design of a definitive study to test which operation produces the best outcomes for patients. Adult patients with a break at the end of the thigh bone treated in one of seven hospitals were eligible to take part in the study. Participants were treated with one of two operations; the choice was made by chance using a computer program. Participants’ basic information and pre-injury health status were recorded and participants were followed up at 6 and 16 weeks. We assessed the rate at which participants agreed to take part in the study and the number who completed follow-up. A value-for-money analysis was performed to determine how to plan this element of a future study. Staff and patients were interviewed about the study processes and the context of the treatments and hospitals to understand how the treatments work and the practicalities of delivering the study. Lower than expected numbers of participants took part in the study; 173 patients were considered for the study, but only 23 agreed to participate. The main reason was that several of the participating surgeons felt strongly that one or the other operation was superior. The rate of follow-up was similar to that of other studies using these treatments. Therefore, the proposed definitive trial is unlikely to be successful if designed in the same way as this feasibility study. Several important considerations that informed the planning of this study were found not to hold true. We believe a modified study could be delivered and could answer this important research question.
Autres résumés
Type: plain-language-summary
(eng)
Breaks of the lower end of the thigh bone are increasingly common injuries. Two operations are used to treat these injuries: a rod placed along the centre of the bone or a plate attached to the edge of the bone. It is not clear which is better. We report the results from a study that will help develop the design of a definitive study to test which operation produces the best outcomes for patients. Adult patients with a break at the end of the thigh bone treated in one of seven hospitals were eligible to take part in the study. Participants were treated with one of two operations; the choice was made by chance using a computer program. Participants’ basic information and pre-injury health status were recorded and participants were followed up at 6 and 16 weeks. We assessed the rate at which participants agreed to take part in the study and the number who completed follow-up. A value-for-money analysis was performed to determine how to plan this element of a future study. Staff and patients were interviewed about the study processes and the context of the treatments and hospitals to understand how the treatments work and the practicalities of delivering the study. Lower than expected numbers of participants took part in the study; 173 patients were considered for the study, but only 23 agreed to participate. The main reason was that several of the participating surgeons felt strongly that one or the other operation was superior. The rate of follow-up was similar to that of other studies using these treatments. Therefore, the proposed definitive trial is unlikely to be successful if designed in the same way as this feasibility study. Several important considerations that informed the planning of this study were found not to hold true. We believe a modified study could be delivered and could answer this important research question.
Identifiants
pubmed: 31549959
doi: 10.3310/hta23510
pmc: PMC6778843
doi:
Banques de données
ISRCTN
['ISRCTN92089567']
Types de publication
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1-132Subventions
Organisme : Department of Health
ID : HTA/15/59/22
Pays : United Kingdom
Organisme : Medical Research Council
ID : MC_UP_A620_1017
Pays : United Kingdom
Organisme : Medical Research Council
ID : MC_UU_12011/4
Pays : United Kingdom
Déclaration de conflit d'intérêts
Matthew L Costa is a member of the UK National Institute for Health Research Health Technology Assessment General Board.
Références
Court-Brown CM, Caesar B. Epidemiology of adult fractures: a review. Injury 2006;37:691–7. https://doi.org/10.1016/j.injury.2006.04.130
doi: https://doi.org/10.1016/j.injury.2006.04.130
Martinet O, Cordey J, Harder Y, Maier A, Bühler M, Barraud GE. The epidemiology of fractures of the distal femur. Injury 2000;31(Suppl. 3):C62–3. https://doi.org/10.1016/S0020-1383(00)80034-0
doi: https://doi.org/10.1016/S0020-1383(00)80034-0
Smith JR, Halliday R, Aquilina AL, Morrison RJ, Yip GC, McArthur J, et al. Distal femoral fractures: the need to review the standard of care. Injury 2015;46:1084–8. https://doi.org/10.1016/j.injury.2015.02.016
doi: https://doi.org/10.1016/j.injury.2015.02.016
Johnell O, Kanis JA. An estimate of the worldwide prevalence, mortality and disability associated with hip fracture. Osteoporos Int 2004;15:897–902. https://doi.org/10.1007/s00198-004-1627-0
doi: https://doi.org/10.1007/s00198-004-1627-0
Bleibler F, Konnopka A, Benzinger P, Rapp K, König HH. The health burden and costs of incident fractures attributable to osteoporosis from 2010 to 2050 in Germany – a demographic simulation model. Osteoporos Int 2013;24:835–47. https://doi.org/10.1007/s00198-012-2020-z
doi: https://doi.org/10.1007/s00198-012-2020-z
Zlowodzki M, Bhandari M, Marek DJ, Cole PA, Kregor PJ. Operative treatment of acute distal femur fractures: systematic review of 2 comparative studies and 45 case series (1989 to 2005). J Orthop Trauma 2006;20:366–71. https://doi.org/10.1097/00005131-200605000-00013
doi: https://doi.org/10.1097/00005131-200605000-00013
Butt MS, Krikler SJ, Ali MS. Displaced fractures of the distal femur in elderly patients. Operative versus non-operative treatment. J Bone Joint Surg Br 1996;78:110–14. https://doi.org/10.1302/0301-620X.78B1.0780110
doi: https://doi.org/10.1302/0301-620X.78B1.0780110
Lu-Yao GL, Keller RB, Littenberg B, Wennberg JE. Outcomes after displaced fractures of the femoral neck. A meta-analysis of one hundred and six published reports. J Bone Joint Surg Am 1994;76:15–25. https://doi.org/10.2106/00004623-199401000-00003
doi: https://doi.org/10.2106/00004623-199401000-00003
Griffin XL, Parsons N, Zbaeda MM, McArthur J. Interventions for treating fractures of the distal femur in adults. Cochrane Database Syst Rev 2015;8:CD010606. https://doi.org/10.1002/14651858.CD010606.pub2
doi: https://doi.org/10.1002/14651858.CD010606.pub2
Harma A, Germen B, Karakas HM, Elmali N, Inan M. The comparison of femoral curves and curves of contemporary intramedullary nails. Surg Radiol Anat 2005;27:502–6. https://doi.org/10.1007/s00276-005-0019-2
doi: https://doi.org/10.1007/s00276-005-0019-2
Browner BD, Edwards CC. The Science and Practice of Intramedullary Nailing. Philadelphia, PA: Lea & Febiger; 1987.
Miller DL, Goswami T, Prayson MJ. Overview of the locking compression plate and its clinical applications in fracture healing. J Surg Orthop Adv 2008;17:271–81.
Hoskins W, Sheehy R, Edwards ER, Hau RC, Bucknill A, Parsons N, et al. Nails or plates for fracture of the distal femur? Bone Joint J 2016;98–B:846–50. https://doi.org/10.1302/0301-620X.98B6.36826
doi: https://doi.org/10.1302/0301-620X.98B6.36826
Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res 2005;14:1523–32. https://doi.org/10.1007/s11136-004-7713-0
doi: https://doi.org/10.1007/s11136-004-7713-0
Tornetta P, Egol KA, Ertl JP, Mullis B, Collinge CA, Ostrum RF. Locked Plating Versus Retrograde Nailing for Distal Femur Fractures: A Multicentre Randomized Trial. Presented at Orthopaedic Trauma Association Annual Meeting, Phoenix, AZ, 10 November 2013, abstract no. 39.
Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ 2015;350:h1258. https://doi.org/10.1136/bmj.h1258
doi: https://doi.org/10.1136/bmj.h1258
Griffin XL, Costa ML, Achten J, Dritsaki M, Baird J, Parsons N. Trial of Acute Femoral Fracture Fixation (TrAFFix): study protocol for a randomised controlled feasibility trial. Trials 2017;18:538. https://doi.org/10.1186/s13063-017-2265-0
doi: https://doi.org/10.1186/s13063-017-2265-0
Kellam JF, Meinberg EG, Agel J, Karam MD, Roberts CS. Introduction: Fracture and Dislocation Classification Compendium-2018: International Comprehensive Classification of Fractures and Dislocations Committee. J Orthop Trauma 2018;32(Suppl. 1):1–10. https://doi.org/10.1097/BOT.0000000000001063
doi: https://doi.org/10.1097/BOT.0000000000001063
Dolan MM, Hawkes WG, Zimmerman SI, Morrison RS, Gruber-Baldini AL, Hebel JR, Magaziner J. Delirium on hospital admission in aged hip fracture patients: prediction of mortality and 2-year functional outcomes. J Gerontol A Biol Sci Med Sci 2000;55:M527–34. https://doi.org/10.1093/gerona/55.9.M527
doi: https://doi.org/10.1093/gerona/55.9.M527
Griffin XL, Achten J, Parsons N, Costa ML. Platelet-rich therapy in the treatment of patients with hip fractures: a single centre, parallel group, participant-blinded, randomised controlled trial. BMJ Open 2013;3:e002583. https://doi.org/10.1136/bmjopen-2013-002583
doi: https://doi.org/10.1136/bmjopen-2013-002583
Great Britain. Mental Capacity Act 2005. London: The Stationery Office; 2005.
Griffin XL, Parsons N, Achten J, Fernandez M, Costa ML. Recovery of health-related quality of life in a United Kingdom hip fracture population. The Warwick Hip Trauma Evaluation – a prospective cohort study. Bone Joint J 2015;97–B:372–82. https://doi.org/10.1302/0301-620X.97B3.35738
doi: https://doi.org/10.1302/0301-620X.97B3.35738
Parsons N, Griffin XL, Achten J, Costa ML. Outcome assessment after hip fracture: is EQ-5D the answer? Bone Joint Res 2014;3:69–75. https://doi.org/10.1302/2046-3758.33.2000250
doi: https://doi.org/10.1302/2046-3758.33.2000250
Cocks K, Torgerson DJ. Sample size calculations for pilot randomized trials: a confidence interval approach. J Clin Epidemiol 2013;66:197–201. https://doi.org/10.1016/j.jclinepi.2012.09.002
doi: https://doi.org/10.1016/j.jclinepi.2012.09.002
Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing 2011;40:423–9. https://doi.org/10.1093/ageing/afr051
doi: https://doi.org/10.1093/ageing/afr051
Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ 2005;173:489–95. https://doi.org/10.1503/cmaj.050051
doi: https://doi.org/10.1503/cmaj.050051
Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med 1991;32:705–14. https://doi.org/10.1016/0277-9536(91)90150-B
doi: https://doi.org/10.1016/0277-9536(91)90150-B
Schwarzer R, Bäßler J, Kwiatek P, Schröder K, Zhang JX. The assessment of optimistic self-beliefs: comparison of the German, Spanish, and Chinese versions of the general self-efficacy scale. Appl Psychol 1997;46:69–88. https://doi.org/10.1111/j.1464-0597.1997.tb01096.x
doi: https://doi.org/10.1111/j.1464-0597.1997.tb01096.x
Brooks R. EuroQol: the current state of play. Health Policy 1996;37:53–72. https://doi.org/10.1016/0168-8510(96)00822-6
doi: https://doi.org/10.1016/0168-8510(96)00822-6
van Hout B, Janssen MF, Feng YS, Kohlmann T, Busschbach J, Golicki D, et al. Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets. Value Health 2012;15:708–15. https://doi.org/10.1016/j.jval.2012.02.008
doi: https://doi.org/10.1016/j.jval.2012.02.008
Hounsome N, Orrell M, Edwards RT. EQ-5D as a quality of life measure in people with dementia and their carers: evidence and key issues. Value Health 2011;14:390–9. https://doi.org/10.1016/j.jval.2010.08.002
doi: https://doi.org/10.1016/j.jval.2010.08.002
Smith SC, Lamping DL, Banerjee S, Harwood RH, Foley B, Smith P, et al. Development of a new measure of health-related quality of life for people with dementia: DEMQOL. Psychol Med 2007;37:737–46. https://doi.org/10.1017/S0033291706009469
doi: https://doi.org/10.1017/S0033291706009469
Mulhern B, Rowen D, Brazier J, Smith S, Romeo R, Tait R, et al. Development of DEMQOL-U and DEMQOL-PROXY-U: generation of preference-based indices from DEMQOL and DEMQOL-PROXY for use in economic evaluation. Health Technol Assess 2013;17(5). https://doi.org/10.3310/hta17050
doi: https://doi.org/10.3310/hta17050
Salén BA, Spangfort EV, Nygren AL, Nordemar R. The Disability Rating Index: an instrument for the assessment of disability in clinical settings. J Clin Epidemiol 1994;47:1423–35. https://doi.org/10.1016/0895-4356(94)90086-8
doi: https://doi.org/10.1016/0895-4356(94)90086-8
Parsons H, Bruce J, Achten J, Costa ML, Parsons NR. Measurement properties of the Disability Rating Index in patients undergoing hip replacement. Rheumatology 2015;54:64–71. https://doi.org/10.1093/rheumatology/keu293
doi: https://doi.org/10.1093/rheumatology/keu293
Lecky F. Twenty-five years of the trauma audit and research network: a continuing evolution to drive improvement. Emerg Med J 2015;32:906–8. https://doi.org/10.1136/emermed-2015-205460
doi: https://doi.org/10.1136/emermed-2015-205460
NHS Digital. NHS Hospital and Community Health Service (HCHS) Workforce Statistics in England, Summary of staff in the NHS 2003–2013. Leeds: NHS Digital; 2014.
NHS Digital. Hospital Admitted Patient Care Activity. Leeds: NHS Digital; 2017.
NHS. The NHS Quarterly Bed Availability. London: NHS England; 2016–17.
NHS. Supporting Facilities Dataset. London: NHS England; 2016–17.
Keene DJ, Mistry D, Nam J, Tutton E, Handley R, Morgan L, et al. The Ankle Injury Management (AIM) trial: a pragmatic, multicentre, equivalence randomised controlled trial and economic evaluation comparing close contact casting with open surgical reduction and internal fixation in the treatment of unstable ankle fractures in patients aged over 60 years. Health Technol Assess 2016;20(75). https://doi.org/10.3310/hta20750
doi: https://doi.org/10.3310/hta20750
Achten J, Parsons NR, Bruce J, Petrou S, Tutton E, Willett K, et al. Protocol for a randomised controlled trial of standard wound management versus negative pressure wound therapy in the treatment of adult patients with an open fracture of the lower limb: UK Wound management of Lower Limb Fractures (UK WOLLF). BMJ Open 2015;5:e009087. https://doi.org/10.1136/bmjopen-2015-009087
doi: https://doi.org/10.1136/bmjopen-2015-009087
Taylor SJ, Bogdan R. Introduction to Qualitative Research Methods: The Search for Meanings. Hoboken, NJ: John Wiley & Sons Inc.; 1984.
Griffin XL, Costa ML, Phelps E, Parsons N, Dritsaki M, Achten J, et al. 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. BMJ Open 2019;9:e026810. https://doi.org/10.1136/bmjopen-2018-026810
doi: https://doi.org/10.1136/bmjopen-2018-026810
Damocles Study Group. A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet 2005;365:711–22. https://doi.org/10.1016/S0140-6736(05)70939-9
doi: https://doi.org/10.1016/S0140-6736(05)70939-9
WK Kellogg Foundation. Logic Model Development Guide. Battle Creek, MI: WK Kellogg Foundation; 2004.
Royal College of Physicians (RCP). National Hip Fracture Database Annual Report 2016. London: RCP; 2016.
Costa ML, Griffin XL, Achten J, Metcalfe D, Judge A, Pinedo-Villanueva R, et al. World Hip Trauma Evaluation (WHiTE): framework for embedded comprehensive cohort studies. BMJ Open 2016;6:e011679. https://doi.org/10.1136/bmjopen-2016-011679
doi: https://doi.org/10.1136/bmjopen-2016-011679
Lidz CW, Appelbaum PS. The therapeutic misconception: problems and solutions. Med Care 2002;40(Suppl. 9):V55–63. https://doi.org/10.1097/01.MLR.0000023956.25813.18
doi: https://doi.org/10.1097/01.MLR.0000023956.25813.18
Phelps EE, Tutton E, Griffin X, Baird J, TrAFFix study co-applicants. Facilitating trial recruitment: a qualitative study of patient and staff experiences of an orthopaedic trauma trial. Trials 2019;20:492. https://doi.org/10.1186/s13063-019-3597-8
doi: https://doi.org/10.1186/s13063-019-3597-8
Griffin XL, Achten J, Sones W, Cook J, Costa ML. Randomised controlled trial of the sliding hip screw versus X-Bolt Dynamic Hip Plating System for the fixation of trochanteric fractures of the hip in adults: a protocol study for WHiTE 4 (WHiTE4). BMJ Open 2018;8:e019944. https://doi.org/10.1136/bmjopen-2017-019944
doi: https://doi.org/10.1136/bmjopen-2017-019944
International Standard Randomised Controlled Trial Number Registry. World Hip Trauma Evaluation Five: A Randomised Controlled Trial Comparing Cemented and Uncemented Implants for the Treatment of Displaced Intracapsular Hip Fractures. URL: https://doi.org/10.1186/ISRCTN18393176 (last accessed 25 October 2018).
doi: https://doi.org/10.1186/ISRCTN18393176
Masters JPM, Achten J, Cook J, Dritsaki M, Sansom L, Costa ML. Randomised controlled feasibility trial of standard wound management versus negative-pressure wound therapy in the treatment of adult patients having surgical incisions for hip fractures. BMJ Open 2018;8:e020632. https://doi.org/10.1136/bmjopen-2017-020632
doi: https://doi.org/10.1136/bmjopen-2017-020632
Achten J, Vadher K, Bruce J, Nanchahal J, Spoors L, Masters JP, et al. Standard wound management versus negative-pressure wound therapy in the treatment of adult patients having surgical incisions for major trauma to the lower limb – a two-arm parallel group superiority randomised controlled trial: protocol for Wound Healing in Surgery for Trauma (WHIST). BMJ Open 2018;8:e022115. https://doi.org/10.1136/bmjopen-2018-022115
doi: https://doi.org/10.1136/bmjopen-2018-022115
National Institute for Health and Care Excellence (NICE). Fractures (Non-complex): Assessment and Management. London: NICE; 2016.
Lincoln YS, Guba E. Naturalistic Inquiry. Newbury Park, CA: Sage Publications Inc; 1985.
Hernlund E, Svedbom A, Ivergård M, Compston J, Cooper C, Stenmark J, et al. Osteoporosis in the European Union: medical management, epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA). Arch Osteoporos 2013;8:136. https://doi.org/10.1007/s11657-013-0136-1
doi: https://doi.org/10.1007/s11657-013-0136-1
Leal J, Gray AM, Prieto-Alhambra D, Arden NK, Cooper C, Javaid MK, Judge A, REFReSH study group. Impact of hip fracture on hospital care costs: a population-based study. Osteoporos Int 2016;27:549–58. https://doi.org/10.1007/s00198-015-3277-9
doi: https://doi.org/10.1007/s00198-015-3277-9
National Institute for Health and Care Excellence (NICE). Guide to the Methods of Technology Appraisal. London: NICE; 2013.
Curtis L, Burns A. Unit Costs of Health and Social Care. Canterbury: PSSRU, University of Kent; 2016.
Department of Health and Social Care (DHSC). NHS Reference Costs 2015 to 2016. London: DHSC; 2016.
National Health Service. NHS Supply Chain Catalogue. URL: https://my.supplychain.nhs.uk/catalogue (accessed March 2018).
Dolan P. Modeling valuations for EuroQol health states. Med Care 1997;35:1095–108. https://doi.org/10.1097/00005650-199711000-00002
doi: https://doi.org/10.1097/00005650-199711000-00002
Curtis L. Unit Costs of Health and Social Care. Canterbury: PSSRU, University of Kent; 2014.
Curtis L, Burns A. Unit Costs of Health and Social Care. Canterbury: PSSRU, University of Kent; 2017.
North Yorkshire County Council. Paying for Care at Home. URL: https://www.northyorks.gov.uk/paying-care-home (accessed March 2018).
Independent People Homecare Services. The Cost of Live in Care. URL: https://www.ip-live-in-care.co.uk/care-costs/live-in-care-costs/ (accessed Mar 2018).
Office for National Statistics (ONS). Annual Survey of Hours and Earnings: 2017 Provisional and 2016 Revised Results. Newport: ONS; 2017.
Curtis L. Unit Costs of Health and Social Care. Canterbury: PSSRU, University of Kent; 2014.
World Health Organization Collaborating Centre for Drug Statistics Methodology. ATC/DDD Index 2018. Oslo: World Health Organization Collaborating Centre for Drug Statistics Methodology. URL: www.whocc.no/atc_ddd_index/ (accessed March 2018).
Joint Formulary Committee. British National Formulary. 74th ed. London: BMJ Group and Pharmaceutical Press; 2017.
Costa ML, Achten J, Griffin J, Petrou S, Pallister I, Lamb SE, Parsons NR, FixDT Trial Investigators. Effect of Locking plate fixation vs intramedullary nail fixation on 6-month disability among adults with displaced fracture of the distal tibia: the UK FixDT Randomized Clinical Trial. JAMA 2017;318:1767–76. https://doi.org/10.1001/jama.2017.16429
doi: https://doi.org/10.1001/jama.2017.16429
Costa ML, Achten J, Hennings S, Boota N, Griffin J, Petrou S, et al. Intramedullary nail fixation versus locking plate fixation for adults with a fracture of the distal tibia: the UK FixDT RCT. Health Technol Assess 2018;22(25). https://doi.org/10.3310/hta22250
doi: https://doi.org/10.3310/hta22250
Sims AL, Parsons N, Achten J, Griffin XL, Costa ML, Reed MR. The world hip trauma evaluation study 3: hemiarthroplasty evaluation by multicentre investigation – WHITE 3: HEMI – an abridged protocol. Bone Joint Res 2016;5:18–25. https://doi.org/10.1302/2046-3758.51.2000473
doi: https://doi.org/10.1302/2046-3758.51.2000473
Costa ML, Jameson SS, Reed MR. Do large pragmatic randomised trials change clinical practice?: assessing the impact of the Distal Radius Acute Fracture Fixation Trial (DRAFFT). Bone Joint J 2016;98–B:410–13. https://doi.org/10.1302/0301-620X.98B3.36730
doi: https://doi.org/10.1302/0301-620X.98B3.36730