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

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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.


Detailed Summary:
Sponsor: RegeneCure, Ltd.

Current Primary Outcome: To demonstrate the safety of the AMCA Bone membrane when used in the treatment of subtrochanteric femoral fractures. [ Time Frame: 12 months ]

Safety element will be measured by evaluation of swelling, clinical signs of superficial or deep infection, pain in the operated area.

Radiographic healing assessment score.



Original Primary Outcome: Safety will be measured by evaluation of swelling, clinical signs of superficial or deep infection, pain in the operated area [ Time Frame: 12 months ]

To demonstrate the safety of the AMCA Bone membrane when used in the treatment of subtrochanteric and distal femoral fractures.


Current Secondary Outcome: To evaluate the performance of the AMCA Bone membrane in providing enhanced healing of compromised fractures at risk of non-union. [ Time Frame: 12 months ]

efficacy will be assessed by radiographic evaluation and functional assessment at different time points.

To evaluate the performance of the AMCA Bone membrane in providing enhanced healing of compromised fractures at risk of non-union, assessed by a difference of ten points in reduction of the completed Harris hip score at 16 weeks from baseline.



Original Secondary Outcome: efficacy will be assessed by radiographic evaluation. [ Time Frame: 12 months ]

To evaluate the performance of the AMCA Bone membrane in providing enhanced healing of compromised fractures at risk of non-union.


Information By: RegeneCure, Ltd.

Dates:
Date Received: September 9, 2012
Date Started:
Date Completion:
Last Updated: August 26, 2013
Last Verified: August 2013