MBCP Safety and Performance in the Osteonecrosis of Femur Head

Osteonecrosis Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00289575
• Other study ID #: 63
• Status: Recruiting
• Phase: Phase 2
• First received: February 9, 2006
• Last updated: March 1, 2007
• Start date: February 2006
• Est. completion date: February 2008

Study information

• Verified date: March 2007
• Source: Biomatlante
• Contact: Thierry FABRE, Pr
• Phone: +33556795544
• Email: thierry.fabre[@]chu-bordeaux.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteonecrosis

Intervention

Device:
• MBCP

Locations

Country	Name	City	State
France	Service de chirurgie orthopédique et traumatologique- Hôpital Pellegrin	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
Biomatlante	CIC Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection and inflammation of the drilled area (blood and clinical assessment).
Primary	Adverse events.
Secondary	Pain (Analogic Visual Scale)
Secondary	Hip function
Secondary	Bone reconstruction evaluation through scanner and radiography