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

NCT ID: NCT01687530

Last Updated: 2013-08-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL

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.

Conditions

Proximal (Subtrochanteric)Femoral Fractures; Distal Femoral Fractures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AMCA bone membrane

AMCA Bone is manufactured from Polyethylene Glycol 400 and Ammonio Methacrylate copolymer type A (Eudragit RL 100) materials.

Group Type: EXPERIMENTAL

AMCA Bone Membrane.

Intervention Type: PROCEDURE

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

Interventions

AMCA Bone Membrane.

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age: 18 to 65 years

2. Both males and females

3. Females of child-bearing potential who have a negative urine hCG pregnancy test following informed consent and prior to surgical procedure and who are not planning to become pregnant for the duration of their part in the study

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

A. Closed fracture B. AO 31 A3, 33b + C1 + C2, and extending to the distal third

5. Proximal subtrochanteric femoral fracture will be treated with a cephalomedullary nail.

6. Patients must be available for follow-up for a minimum of 12 months.

Exclusion Criteria

1. Trauma presentation

• Open fractures
• Bilateral fractures
• Polytrauma with head injury
• Presence of periprosthetic fractures

2. Patient Medical History

• Previous malignancy (except basal cell carcinoma of the skin)
• Active autoimmune disease
• Metabolic bone disease (primary or secondary)
• Chronic renal insufficiency (defined by a Glomerular Filtration Rate of <30 ml/min)
• Liver function abnormality (defined by presence of ALT or AST levels more than double the upper limit)
• Current smoker

3. Concurrent medication

o Medications that may interfere with bone metabolism including:

4. Calcitonin for 7 days or more within the last 6 months prior to study

5. Bisphosphonates for 30 days or more within the last 12 months prior to study

6. Bone therapeutic doses of vitamin D or vitamin D metabolites for 30 days or more within the last 6 months

• Previous or present immunosuppressive treatment
• Previous radiotherapy or chemotherapy
• Cumulative dose of 150mg total prednisolone or any other gluco-corticosteroid for 7 days or more within the last 6 months prior to study
• Previous history of or current alcohol abuse
• Previous history of or current drug addiction/abuse

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RegeneCure, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amal Khoury, M.D

Role: STUDY_DIRECTOR

Hadassah Medical Organization

Locations

Hadassah Medical Organization, Orthopedic Surgery Department

Jerusalem, , Israel

Orthopedic Department, Hadassah Medical Organization

Jerusalem, , Israel

Countries

United Kingdom; Israel

Facility Contacts

Amal Khoury, M.D

Role: primary

Amal Khoury

Role: primary

Other Identifiers

REGO01/12

Identifier Type: -

Identifier Source: org_study_id