Evaluation of the Safety and Efficacy of a Guided Bone Regeneration Membrane for the Treatment of Femoral Fractures
|ClinicalTrials.gov Identifier: NCT01687530|
Recruitment Status : Unknown
Verified August 2013 by RegeneCure, Ltd..
Recruitment status was: Not yet recruiting
First Posted : September 19, 2012
Last Update Posted : August 27, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Proximal (Subtrochanteric)Femoral Fractures Distal Femoral Fractures||Procedure: AMCA Bone Membrane.||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Fractures|
Experimental: AMCA bone membrane
AMCA Bone is manufactured from Polyethylene Glycol 400 and Ammonio Methacrylate copolymer type A (Eudragit RL 100) materials.
Procedure: AMCA Bone Membrane.
AMCA Bone Membrane, as a bone stimulating aid for orthopedic trauma applications.
- 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.
- 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.
- To evaluate the performance of the AMCA Bone membrane in providing enhanced healing of compromised fractures at risk of non-union, assessed by a User Satisfaction [ Time Frame: 12 months ]User Satisfaction, Usability Lack of side effects Reduction of the incidences rate of secondary intervention
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687530
|Hadassah Medical Organization, Orthopedic Surgery Department|
|Contact: Amal Khoury, M.D 972-2-6779549 email@example.com|
|Orthopedic Department, Hadassah Medical Organization|
|Contact: Amal Khoury +97226779549|
|Study Director:||Amal Khoury, M.D||Hadassah Medical Organization|