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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by RegeneCure, Ltd.
Sponsor:
Information provided by (Responsible Party):
RegeneCure, Ltd.
ClinicalTrials.gov Identifier:
NCT01687530
First received: September 9, 2012
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Proximal (Subtrochanteric)Femoral Fractures
Distal Femoral Fractures
Procedure: AMCA Bone Membrane.
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by RegeneCure, Ltd.:

Primary Outcome Measures:
  • To demonstrate the safety of the AMCA Bone membrane when used in the treatment of subtrochanteric femoral fractures. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.



Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    User Satisfaction, Usability Lack of side effects Reduction of the incidences rate of secondary intervention


Estimated Enrollment: 48
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687530

Locations
Israel
Hadassah Medical Organization, Orthopedic Surgery Department Not yet recruiting
Jerusalem, Israel
Contact: Amal Khoury, M.D    972-2-6779549    akhoury@hadassah.org.il   
Orthopedic Department, Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Contact: Amal Khoury    +97226779549      
Sponsors and Collaborators
RegeneCure, Ltd.
Investigators
Study Director: Amal Khoury, M.D Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: RegeneCure, Ltd.
ClinicalTrials.gov Identifier: NCT01687530     History of Changes
Other Study ID Numbers: REGO01/12
Study First Received: September 9, 2012
Last Updated: August 26, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014