Treatment of Osteonecrosis of the Femoral Head by Bone Marrow Transplantation

NCT ID: NCT00821470

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-01-31
• Study Completion Date: 2008-09-30

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.

Conditions

Necrosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

bone marrow graft group

core decompression + bone marrow implantation into the necrotic lesion

Group Type: EXPERIMENTAL

core decompression

Intervention Type: PROCEDURE

core decompression procedure only

Bone marrow implantation into the necrotic lesion

Intervention Type: PROCEDURE

control

core decompression

Group Type: ACTIVE_COMPARATOR

core decompression

Intervention Type: PROCEDURE

core decompression procedure only

Interventions

core decompression

core decompression procedure only

Intervention Type: PROCEDURE

Bone marrow implantation into the necrotic lesion

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fonds National de la Recherche Scientifique

OTHER

Sponsor Role: collaborator

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Erasme Hospital

Principal Investigators

valerie gangji

Role: PRINCIPAL_INVESTIGATOR

Erasme hospital

Locations

Erasme Hospital

Brussels, , Belgium

Countries

Belgium

Other Identifiers

ref. 98/20

Identifier Type: -

Identifier Source: org_study_id