Evaluation of the Safety and Efficacy of a Guided Bone Regeneration Membrane for the Treatment of Femoral Fractures

Inclusion Criteria:

1. Age: 18 to 65
2. Males Females - non child bearing potential, or females of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent.
3. Femoral subtrochanteric fracture and/or fracture of the distal third of the femur

4. The fracture is classified as one of the following:

   • Closed fracture
   • AO 31 A3, 33b + C1 + C2, and extending to the distal third (see Appendix A for AO fracture classification)
5. Distal femur fracture will be treated with distal femoral anatomical locking, plate.

6. 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:

1. Active systemic or local infection.
2. History of malignancy, radiotherapy, or chemotherapy for malignancy (except basal cell carcinoma of the skin)
3. Active autoimmune disease.
4. Any past or present immunosuppressive treatment.
5. Open fractures.
6. Administration of drugs that may interfere with bone metabolism:
7. Accumulative dose of 150 mg total prednisone or any other gluco-corticosteroid for 7 days or more, within the last 6 months prior to the study;
8. Calcitonin for 7 days or more within the last 6 months prior to the study;
9. Bisphosphonates for 30 days or more within the last 12 months prior to the study;
10. Bone therapeutic doses of fluoride for 30 days or more within the last 12 months prior to the study;
11. Bone therapeutic doses of vitamin D or vitamin D metabolites for 30 days or more within the last 6 months;
12. Current treatment with chemotherapeutic agents.
13. History of metabolic bone disease (primary or secondary).
14. Chronic renal insufficiency (defined by 50% increase of normal levels).
15. Administration of marrow suppressive drugs (e.g., vancomycin).
16. Alcohol abuse
17. Drug addiction
18. Smoking (more than 20 cigarettes per day)Bilateral fractures 19 Polytrauma with head injury and patient with periprosthetic fractures.