MBCP Safety and Performance in the Osteonecrosis of Femur Head

Biomatlante

Status and phase: Unknown; Phase 2

Conditions: Osteonecrosis

Treatments: Device: MBCP

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00289575

63

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)