Treatment of Osteonecrosis of the Femoral Head by Bone Marrow Transplantation

Phase 1

Completed

• Conditions: Necrosis
• Interventions: Procedure: core decompression; Procedure: Bone marrow implantation into the necrotic lesion

• Registration Number: NCT00821470
• Lead Sponsor: Erasme University Hospital

Brief Summary

Aseptic non traumatic osteonecrosis (ON) is a painful disorder of the hip which often leads, in its final stage, to femoral head collapse and subsequent total hip replacement. Core decompression of the hip is the most widespread procedure used to treat early stage ON of the femoral head. Notwithstanding the fact that this procedure has been employed for more than three decades (2), its efficacy remains controversial (3;4). Recently, one suggested that ON might be a disease of bone cells and/or of mesenchymal cells. The levels of activity and the number of mesenchymal stem cells in both the hematopoietic and in the stromal compartments of the bone marrow have been shown to be depressed in patients with ON of the femoral head (9). The investigators have showed previously that the capacity of osteoblastic cells to replicate was decreased in the proximal femur of patients with ON of the femoral head (10). This finding raised the possibility that bone marrow containing stromal cells which have many of the characteristics of stem cell for mesenchymal tissues including bone could be implanted into the necrotic lesion of the femoral head.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-01
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Study First Submitted: 2009-01-12
• Study First Submitted QC: 2009-01-12
• Study First Posted: 2009-01-13
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-27
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• ARCO stage 1 or 2 osteonecrosis of the femoral head

Exclusion Criteria

• The investigators excluded patients with evidence of a malignant disorder during the past five years.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	core decompression	core decompression
bone marrow graft group	Bone marrow implantation into the necrotic lesion	core decompression + bone marrow implantation into the necrotic lesion
bone marrow graft group	core decompression	core decompression + bone marrow implantation into the necrotic lesion

Primary Outcome Measures

Name	Time	Method
WOMAC Score	60 months

Secondary Outcome Measures

Name	Time	Method
Disease progression defined as progression to a fractural stage of osteonecrosis	60 months

Trial Locations

Locations (1)

Erasme Hospital; 🇧🇪 Brussels, Belgium