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.
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.


METHODS
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.


BACKGROUND
Current Controlled Trials ISRCTN49197425.
Griffin
Xavier Luke
XL
Clinical Sciences Research Institute, University of Warwick Medical School, Coventry, UK. x.griffin@warwick.ac.uk
Parsons
Nick
N
Achten
Juul
J
Costa
Matthew L
ML
D019644:Arthroplasty, Replacement, Hip / Q000379:methods; D002985:Clinical Protocols / Q000592:standards; D005265:Femoral Neck Fractures / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D005593:Fracture Fixation, Internal / Q000379:methods*; D017102:Fracture Healing / Q000502:physiology; D006620:Hip Fractures / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D006801:Humans; D019637:Orthopedic Procedures / Q000379:methods*; D017063:Outcome Assessment, Health Care / Q000379:methods*; D011183:Postoperative Complications / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control; D011859:Radiography