Treatment of Osteonecrosis of the Femoral Head by Bone Marrow Transplantation
Primary Purpose
Necrosis
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
core decompression
Bone marrow implantation into the necrotic lesion
Sponsored by
About this trial
This is an interventional treatment trial for Necrosis focused on measuring osteonecrosis, bone marrow, core decompression, femoral head
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.
Sites / Locations
- Erasme Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
bone marrow graft group
control
Arm Description
core decompression + bone marrow implantation into the necrotic lesion
core decompression
Outcomes
Primary Outcome Measures
WOMAC Score
Secondary Outcome Measures
Disease progression defined as progression to a fractural stage of osteonecrosis
Full Information
NCT ID
NCT00821470
First Posted
January 12, 2009
Last Updated
February 27, 2020
Sponsor
Erasme University Hospital
Collaborators
Fonds National de la Recherche Scientifique
1. Study Identification
Unique Protocol Identification Number
NCT00821470
Brief Title
Treatment of Osteonecrosis of the Femoral Head by Bone Marrow Transplantation
Official Title
Treatment of Osteonecrosis of the Femoral Head With Implantation of Autologous Bone Marrow Cells, a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Erasme University Hospital
Collaborators
Fonds National de la Recherche Scientifique
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrosis
Keywords
osteonecrosis, bone marrow, core decompression, femoral head
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bone marrow graft group
Arm Type
Experimental
Arm Description
core decompression + bone marrow implantation into the necrotic lesion
Arm Title
control
Arm Type
Active Comparator
Arm Description
core decompression
Intervention Type
Procedure
Intervention Name(s)
core decompression
Intervention Description
core decompression procedure only
Intervention Type
Procedure
Intervention Name(s)
Bone marrow implantation into the necrotic lesion
Primary Outcome Measure Information:
Title
WOMAC Score
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Disease progression defined as progression to a fractural stage of osteonecrosis
Time Frame
60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
valerie gangji
Organizational Affiliation
Erasme hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasme Hospital
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Treatment of Osteonecrosis of the Femoral Head by Bone Marrow Transplantation
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