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Warwick hip trauma study : a randomised clinical trial comparing interventions to improve outcomes in internally fixed intracapsular fractures of the proximal femur : protocol for The WHiT Study

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Griffin, Xavier Luke, Parsons, Nicholas R., Achten, Juul and Costa, Matthew L.. (2010) Warwick hip trauma study : a randomised clinical trial comparing interventions to improve outcomes in internally fixed intracapsular fractures of the proximal femur : protocol for The WHiT Study. BMC Musculoskeletal Disorders, Vol.11 . Article 184. ISSN 1471-2474

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Official URL: http://dx.doi.org/10.1186/1471-2474-11-184

Abstract

Background Controversy exists regarding the optimal treatment for patients with displaced intracapsular fractures of the proximal femur. The recognised treatment alternatives are arthroplasty and internal fixation. The principal criticism of internal fixation is the high rate of non-union; up to 30% of patients will have a failure of the fixation leading to revision surgery. We believe that improved fracture healing may lead to a decreased rate of failure of fixation. We therefore propose to investigate strategies to both accelerate fracture healing and improve fixation that may significantly improve outcomes after internal fixation of intracapsular femoral fractures. We aim to test the clinical effectiveness of the osteoinductive agent platelet rich plasma and conduct a pilot study of a novel fixed-angle fixation system. Design We have planned a three arm, single centre, standard-of-care controlled, double blinded, pragmatic, randomised clinical trial. The trial will include a standard two-way comparison between platelet-rich plasma and standard-of-care fixation versus standard-of-care fixation alone. In addition there will be a subsidiary pilot arm testing a fixed-angle screw and plate fixation system.

Item Type: Journal Article
Subjects: R Medicine > RD Surgery
Divisions: Faculty of Medicine > Warwick Medical School > Clinical Sciences Research Institute (CSRI)
Faculty of Medicine > Warwick Medical School > Health Sciences
Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Femur -- Fractures, Internal fixation in fractures, Fractures, Ununited, Blood plasma
Journal or Publication Title: BMC Musculoskeletal Disorders
Publisher: BioMed Central Ltd.
ISSN: 1471-2474
Date: 17 August 2010
Volume: Vol.11
Page Range: Article 184
Identification Number: 10.1186/1471-2474-11-184
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
Funder: Furlong Research Charitable Foundation, BUPA Foundation
Grant number: TBF-RR10-001 (BUPA)
References: 1. Johnell O, Kanis JA: An estimate of the worldwide prevalence, mortality and disability associated with hip fracture. Osteoporos Int 2004, 15(11):897-902. 2. D’Arcy J, Devas M: Treatment of fractures of the femoral neck by replacement with the Thompson prosthesis. The Journal of bone and joint surgery 1976, 58-B(3):279-286. 3. 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. The Journal of bone and joint surgery 1994, 76(1):15-25. 4. Parker MJ, Gurusamy K: Internal fixation versus arthroplasty for intracapsular proximal femoral fractures in adults. Cochrane Database Syst Rev 2006, 4:CD001708. 5. Griffin XL, Smith CM, Costa ML: The clinical use of platelet-rich plasma in the promotion of bone healing: a systematic review. Injury 2009, 40(2):158-162. 6. Parker MJ: Preliminary results of a new dynamic locking plate and screw system for intracapsular hip fractures. Injury Extra 2008, 39(5):200. 7. NCT00384358 Cg: A Phase 2, Multicenter, Single-Blind, Randomized, Stratified, Standard-of-Care Controlled, Feasibility and Safety Study of rhBMP-2/CPM as an Adjuvant Therapy for Fractures of the Proximal Femur. 2007. 8. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, F SK, Simel D, et al: Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996, 276:637-639. 9. Parker MJ, Raghavan R, Gurusamy K: Incidence of fracture-healing Complications after Femoral Neck Fractures. Clinical Orthopaedics and Related Research 2007. 10. Parker MJ, Khan RJ, Crawford J, Pryor GA: Hemiarthroplasty versus internal fixation for displaced intracapsular hip fractures in the elderly. A randomised trial of 455 patients. The Journal of bone and joint surgery 2002, 84(8):1150-1155. 11. Dupont W, Plummer D: PS: Power and Sample Size.. 12. Garden RS: Low-Angle fixation in fractures of the femoral neck. The Journal of bone and joint surgery 1961, 43:647-663. 13. Parker MJ: Garden grading of intracapsular fractures: meaningful or misleading? Injury 1993, 24(4):241-242.
URI: http://wrap.warwick.ac.uk/id/eprint/3366

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