Abstract
BackgroundControversy 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.DesignWe 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.Trial RegistrationCurrent Controlled Trials ISRCTN49197425
Highlights
Controversy exists regarding the optimal treatment for patients with displaced intracapsular fractures of the proximal femur
Hypothesis We propose to test the hypotheses that: platelet-rich plasma (PRP) leads to a reduced incidence of failure of fixation in patients with intracapsular fractures of the proximal femur
We propose to explore the size of any treatment effect due to a novel fixed-angle screw and plate system in the treatment of patients with intracapsular fractures of the proximal femur
Summary
Controversy exists regarding the optimal treatment for patients with displaced intracapsular fractures of the proximal femur. We propose to investigate strategies to both accelerate fracture healing and improve fixation that may significantly improve outcomes after internal fixation of intracapsular femoral fractures. Proximal femoral fractures constitute a heavy socioeconomic burden worldwide. The cost of this clinical problem is estimated at 1.75 million disability adjusted life years lost, 1.4% of the total healthcare burden in established market economies [1]. Half of all proximal femoral fractures are intracapsular These fractures are at risk of healing complications as the blood supply to the femoral head may be compromised by the fracture. There are two operative strategies in the management of intracapsular fractures of the proximal femur: internal fixation and hip arthroplasty
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