Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow

Not Applicable

Completed

• Conditions: Non Traumatic Osteonecrosis of the Femoral Head (Hip)
• Interventions: Procedure: core decompression of the femoral head; Procedure: core decompression with autologous bone marrow implantation

• Registration Number: NCT01544712
• Lead Sponsor: University of Liege

Brief Summary

In stage 3 Osteonecrosis (ON) of the femoral head, a beneficial effect of bone marrow grafting was reported with a reduction of the functional evolution and the necessity of a total prosthesis placement in a non-controlled retrospective trial. Based on this experience, the investigators would like to start a randomized controlled double blind study on the effect of autologous implantation of autologous bone marrow cells into the necrotic lesion of stage 3 ON of the femoral head.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2012-02
• Study First Submitted: 2012-02-22
• Study First Submitted QC: 2012-03-05
• Last Update Submitted: 2012-03-05
• Study First Posted: 2012-03-06
• Last Update Posted: 2012-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. patients who have a non traumatic ON of the femoral head
2. Stage 3 ON (subchondral fracture).
3. Age > 18 years
4. Be able and willing to participate in the study

Exclusion Criteria

1. evidence of malignant disorder in the past five years
2. Patient unable to undergo a MRI.
3. Patient who is positive for an HIV, hepatitis B or C infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	core decompression of the femoral head	Core decompression
Bone marrow	core decompression with autologous bone marrow implantation	core decompression plus autologous concentrated bone marrow

Primary Outcome Measures

Name	Time	Method
reduction of total prosthesis	24, 60 months	Need to undergo a surgical treatment total prosthesis

Secondary Outcome Measures

Name	Time	Method
Pain reduction	24, 60 months	Visual analogue scale
functional status	24, 60 months	Lequesne and WOMAC scores

Trial Locations

Locations (1)

University of Liège; 🇧🇪 Liège, Belgium