Trial record 16 of 93 for:    osteonecrosis

Treatment of Osteonecrosis of the Femoral Head by Bone Marrow Transplantation

This study has been completed.
Sponsor:
Collaborator:
Fonds National de la Recherche Scientifique
Information provided by:
Erasme University Hospital
ClinicalTrials.gov Identifier:
NCT00821470
First received: January 12, 2009
Last updated: January 13, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Necrosis
Procedure: core decompression
Procedure: Bone marrow implantation into the necrotic lesion
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Osteonecrosis of the Femoral Head With Implantation of Autologous Bone Marrow Cells, a Pilot Study

Resource links provided by NLM:


Further study details as provided by Erasme University Hospital:

Primary Outcome Measures:
  • WOMAC Score [ Time Frame: 60 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease progression defined as progression to a fractural stage of osteonecrosis [ Time Frame: 60 months ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: January 1999
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bone marrow graft group
core decompression + bone marrow implantation into the necrotic lesion
Procedure: core decompression
core decompression procedure only
Procedure: Bone marrow implantation into the necrotic lesion
Active Comparator: control
core decompression
Procedure: core decompression
core decompression procedure only

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00821470

Locations
Belgium
Erasme Hospital
Brussels, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
Fonds National de la Recherche Scientifique
Investigators
Principal Investigator: valerie gangji Erasme Hospital
  More Information

No publications provided

Responsible Party: Valerie Gangji, Erasme Hospital
ClinicalTrials.gov Identifier: NCT00821470     History of Changes
Other Study ID Numbers: ref. 98/20
Study First Received: January 12, 2009
Last Updated: January 13, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Erasme University Hospital:
osteonecrosis
bone marrow
core decompression
femoral head

Additional relevant MeSH terms:
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014