NCT01687530

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: RegeneCure, Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Certain types of fractures require surgical intervention that may involve the use of bone grafts or bone graft substitutes. Many of the materials used as bone graft substitutes suffer from disadvantages such as soft tissue invasion of the fracture area, inadequate blood supply, failure to encourage the production of bone and ectopic bone formation. A guided bone regeneration (GBR) environment may help in solving these clinical concerns. GBR has been widely used in the field of dentistry since the 1980s to provide stable placement for dental implants The purpose of this study is to evaluate the safety, performance and initial efficacy of Regenecure's, AMCA Bone Membrane, as a bone stimulating aid for orthopedic trauma applications.

Conditions

• Proximal (Subtrochanteric)Femoral Fractures
• Distal Femoral Fractures

Interventions

Type	Name	Description
PROCEDURE	AMCA Bone Membrane.	AMCA Bone Membrane, as a bone stimulating aid for orthopedic trauma applications.

Timeline

• First posted: 2012-09-19
• Last updated: 2013-08-27

Locations

2 sites across 1 country: Israel