Treatment of Osteonecrosis of the Femoral Head by Bone Marrow Transplantation

NCT00821470 | Completed Phase 1 DMC

• 1 other identifier: ref. 98/20
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Keywords

osteonecrosis; bone marrow; core decompression; femoral head

Outcome Measures

Primary Outcomes (1)

• WOMAC Score

  60 months

Secondary Outcomes (1)

• Disease progression defined as progression to a fractural stage of osteonecrosis

  60 months

Study Arms (2)

bone marrow graft group

EXPERIMENTAL

core decompression + bone marrow implantation into the necrotic lesion

Procedure: core decompression; Procedure: Bone marrow implantation into the necrotic lesion

control

ACTIVE COMPARATOR

core decompression

Procedure: core decompression

Interventions

core decompression PROCEDURE

core decompression procedure only

bone marrow graft group; control

Bone marrow implantation into the necrotic lesion PROCEDURE

bone marrow graft group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ARCO stage 1 or 2 osteonecrosis of the femoral head

You may not qualify if:

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

Sponsors & Collaborators

• Erasme University Hospital: lead
• Fonds National de la Recherche Scientifique: collaborator

Study Sites (1)

Erasme Hospital

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Necrosis; Osteonecrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases

Study Officials

• valerie gangji

  Erasme University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2009
• First Posted: January 13, 2009
• Study Start: January 1, 1999
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: February 28, 2020

Record last verified: 2020-02

Locations

BE (1)