Treatment of Osteonecrosis of the Femoral Head by Bone Marrow Transplantation

Overview

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.

Full Title of Study: “Treatment of Osteonecrosis of the Femoral Head With Implantation of Autologous Bone Marrow Cells, a Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2008

Interventions

  • Procedure: core decompression
    • core decompression procedure only
  • Procedure: Bone marrow implantation into the necrotic lesion

Arms, Groups and Cohorts

  • Experimental: bone marrow graft group
    • core decompression + bone marrow implantation into the necrotic lesion
  • Active Comparator: control
    • core decompression

Clinical Trial Outcome Measures

Primary Measures

  • WOMAC Score
    • Time Frame: 60 months

Secondary Measures

  • Disease progression defined as progression to a fractural stage of osteonecrosis
    • Time Frame: 60 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Erasme University Hospital
  • Collaborator
    • Fonds National de la Recherche Scientifique
  • Provider of Information About this Clinical Study
    • Valerie Gangji, Erasme Hospital
  • Overall Official(s)
    • valerie gangji, Principal Investigator, Erasme hospital

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