Randomised Controlled Trial to Evaluate the Safety Performance and Initial Efficacy of a Guided Bone Regeneration Membrane for the Treatment of Proximal (Subtrochanteric) Femoral Fractures

Inclusion Criteria: Age: 18 to 65 years Both males and females Females of child-bearing potential who have a negative urine hCG pregnancy test following informed consent and prior to surgical procedure and who are not planning to become pregnant for the duration of their part in the study Femoral subtrochanteric fracture. The fracture is classified as one of the following: A. Closed fracture B. AO 31 A3, 33b + C1 + C2, and extending to the distal third Proximal subtrochanteric femoral fracture will be treated with a cephalomedullary nail. Patients must be available for follow-up for a minimum of 12 months. Exclusion Criteria: Trauma presentation Open fractures Bilateral fractures Polytrauma with head injury Presence of periprosthetic fractures Patient Medical History Previous malignancy (except basal cell carcinoma of the skin) Active autoimmune disease Metabolic bone disease (primary or secondary) Chronic renal insufficiency (defined by a Glomerular Filtration Rate of <30 ml/min) Liver function abnormality (defined by presence of ALT or AST levels more than double the upper limit) Current smoker Concurrent medication o Medications that may interfere with bone metabolism including: Calcitonin for 7 days or more within the last 6 months prior to study Bisphosphonates for 30 days or more within the last 12 months prior to study Bone therapeutic doses of vitamin D or vitamin D metabolites for 30 days or more within the last 6 months Previous or present immunosuppressive treatment Previous radiotherapy or chemotherapy Cumulative dose of 150mg total prednisolone or any other gluco-corticosteroid for 7 days or more within the last 6 months prior to study Previous history of or current alcohol abuse Previous history of or current drug addiction/abuse