Back to results

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

Primary Purpose

Proximal (Subtrochanteric)Femoral Fractures, Distal Femoral Fractures

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

AMCA Bone Membrane.

About this trial

This is an interventional treatment trial for Proximal (Subtrochanteric)Femoral Fractures

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Hadassah Medical Organization, Orthopedic Surgery Department
Orthopedic Department, Hadassah Medical Organization

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AMCA bone membrane

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT01687530

First Posted

September 9, 2012

Last Updated

August 26, 2013

Sponsor

RegeneCure, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01687530

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Unknown status

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RegeneCure, Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Proximal (Subtrochanteric)Femoral Fractures, Distal Femoral Fractures

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AMCA bone membrane

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

AMCA Bone Membrane.

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

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

Description

User Satisfaction, Usability Lack of side effects Reduction of the incidences rate of secondary intervention

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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 Bisphosphonates for 30 days or more within the last 12 months prior to study 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amal Khoury, M.D

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Study Director

Facility Information:

Facility Name

Hadassah Medical Organization, Orthopedic Surgery Department

City

Jerusalem

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amal Khoury, M.D

Phone

972-2-6779549

akhoury@hadassah.org.il

Facility Name

Orthopedic Department, Hadassah Medical Organization

City

Jerusalem

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amal Khoury

Phone

+97226779549

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs