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

NCT01687530 | Unknown Phase 1 DMC

• 1 other identifier: REGO01/12
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  12 months

Secondary Outcomes (1)

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

  12 months

Other Outcomes (1)

• 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

  12 months

Study Arms (1)

AMCA bone membrane

EXPERIMENTAL

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

Procedure: AMCA Bone Membrane.

Interventions

AMCA Bone Membrane. PROCEDURE

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

AMCA bone membrane

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 65 years
• Both males and females
• 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
• 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
• Proximal subtrochanteric femoral fracture will be treated with a cephalomedullary nail.
• Patients must be available for follow-up for a minimum of 12 months.

You may not qualify if:

• Trauma presentation
• Open fractures
• Bilateral fractures
• Polytrauma with head injury
• Presence of periprosthetic fractures
• 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
• Concurrent medication
• o Medications that may interfere with bone metabolism including:
• Calcitonin for 7 days or more within the last 6 months prior to study

Sponsors & Collaborators

• RegeneCure, Ltd.: lead

Study Sites (2)

Hadassah Medical Organization, Orthopedic Surgery Department

Jerusalem, Israel

Location

Orthopedic Department, Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Femoral Fractures, Distal

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Amal Khoury, M.D

  Hadassah Medical Organization

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2012
• First Posted: September 19, 2012
• Last Updated: August 27, 2013

Record last verified: 2013-08

Locations

IL (2)