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MBCP Safety and Performance in the Osteonecrosis of Femur Head

Primary Purpose

Osteonecrosis

Status

Unknown status

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

MBCP

About this trial

This is an interventional treatment trial for Osteonecrosis focused on measuring Femur head aseptic osteonecrosis, Bone reconstruction, Macroporous biphasic calcium phosphate granules

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: femur head osteonecrosis (1 to 2 level in ARCO scale) signed informed consent Exclusion Criteria: primary bone infection femur head sphericity loss cancer, diabetes, tuberculosis previous history HIV, Hepatitis B, Hepatitis C infection drepanocytosis current corticotherapy current immunosuppressive therapy innate or acquired immune deficience pregnancy or lack of efficient contraception current participation in an other study

Sites / Locations

Service de chirurgie orthopédique et traumatologique- Hôpital PellegrinRecruiting

Outcomes

Primary Outcome Measures

Infection and inflammation of the drilled area (blood and clinical assessment).

Adverse events.

Secondary Outcome Measures

Pain (Analogic Visual Scale)

Hip function

Bone reconstruction evaluation through scanner and radiography

Full Information

NCT ID

NCT00289575

First Posted

February 9, 2006

Last Updated

March 1, 2007

Sponsor

Biomatlante

Collaborators

CIC Bordeaux

1. Study Identification

Unique Protocol Identification Number

NCT00289575

Brief Title

MBCP Safety and Performance in the Osteonecrosis of Femur Head

Official Title

Evaluation of Safety and Performance of Macroporous Biphasic Calcium Phosphate Granules Combined With Cellulosic-Derived Gel, in Filling Bones Gap After Aseptic Osteonecrosis Biopsy of Femur Head.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2007

Overall Recruitment Status

Unknown status

Study Start Date

February 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Biomatlante

Collaborators

CIC Bordeaux

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this pilot study is to evaluate MBCP performance in bone regeneration after osteonecrosis biopsy of the femur head. This technic may prevent the neck of the femur bone weakness following the healthy area drilling, thanks to a bone reconstruction at the expense of the biomaterial.

Detailed Description

Twelve patients will be enrolled in this study and evaluation of infection and inflammation of the drilled area, pain and hip function will be assessed during a one year follow up. Bone reconstruction will be evaluated with scanner and radiography.

6. Conditions and Keywords

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

Osteonecrosis

Keywords

Femur head aseptic osteonecrosis, Bone reconstruction, Macroporous biphasic calcium phosphate granules

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

MBCP

Primary Outcome Measure Information:

Title

Infection and inflammation of the drilled area (blood and clinical assessment).

Title

Adverse events.

Secondary Outcome Measure Information:

Title

Pain (Analogic Visual Scale)

Title

Hip function

Title

Bone reconstruction evaluation through scanner and radiography

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Thierry FABRE, Pr

Phone

+33556795544

thierry.fabre@chu-bordeaux.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Dominique CHAUVEAUX, Pr

Phone

+33556795679

dominique.chauveaux@chu-bordeaux.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thierry FABRE, Pr

Organizational Affiliation

University Hospital, Bordeaux

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jacques DEMOTES-MAINARD, Pr

Organizational Affiliation

Clinical Research Center INSERM/Bordeaux University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Service de chirurgie orthopédique et traumatologique- Hôpital Pellegrin

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thierry FABRE, ¨Pr

Phone

+33556795544

thierry.fabre@chu-bordeaux.fr

First Name & Middle Initial & Last Name & Degree

Dominique CHAUVEAUX, pr

Phone

+33556795679

dominique.chauveaux@chu-bordeaux.fr

First Name & Middle Initial & Last Name & Degree

Thierry FABRE, Pr

12. IPD Sharing Statement

Learn more about this trial

MBCP Safety and Performance in the Osteonecrosis of Femur Head

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