MBCP Safety and Performance in the Osteonecrosis of Femur Head

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteonecrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MBCP

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No