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

NCT01687530 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2013-08-27

No results posted yet for this study

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

PROCEDURE

AMCA Bone Membrane.

AMCA Bone Membrane, as a bone stimulating aid for orthopedic trauma applications.

Sponsors & Collaborators

  • RegeneCure, Ltd.

    lead INDUSTRY

Principal Investigators

  • Amal Khoury, M.D · Hadassah Medical Organization

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01687530 on ClinicalTrials.gov