Institution: The University of Warwick
Investigators: Mr Xavier Griffin, Mr Matt Costa
Stream: Clinical Fellowship
Topic: Lower Limbs (Hip)
Status: Live
In the first year of this fellowship, we will carry out a clinical study to assess the impact of intracapsular fractures on the vascularity of the femoral head using a previously validated technique. All study documentation for data management will be prepared. Recruitment for the main trial will begin during the 2nd year.
This study will test the principle hypothesis that biological interventions can reduce the proportion of patients with intracapsular proximal femoral fractures in whom internal fixation fails. The study will be randomised, placebo-controlled clinical trial. Patients will be randomised to either placebo or PRP as an adjunct to routine internal fixation of their fracture. Both groups will receive normal rehabilitation care, physiotherapy and clinical follow-up.
The primary outcome measure will be failure of fixation requiring operative revision within the first year after the index surgery. We have defined a 10% absolute risk reduction of the primary outcome as the minimum clinically relevant difference.
Secondary outcomes measured will include, radiographic non-union rate at one year, the Hip Fracture Functional Recovery Score at 1 year, preoperative complication and length of index hospital stay. The clinical impact of biological interventions in acute fracture healing has been the subject of great interest in the orthopaedic community recently. We aim to provide the first robust research protocol for the randomised clinical study.
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A Randomised
Controlled Trial of Platelet Rich Plasma to Reduce Fixation Failure in Intracapsular Fractures of Proximal
