Treatment of Osteonecrosis of the Femoral Head by Bone Marrow Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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Treatment of Osteonecrosis of the Femoral Head With Implantation of Autologous Bone Marrow Cells, a Pilot Study

Conditions
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Necrosis

Intervention / Treatment
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* Procedure: core decompression
* Procedure: Bone marrow implantation into the necrotic lesion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bone marrow graft group<br>core decompression + bone marrow implantation into the necrotic lesion | Procedure: core decompression<br>* core decompression procedure only<br>Procedure: Bone marrow implantation into the necrotic lesion<br> <br> |
| Active Comparator: control<br>core decompression | Procedure: core decompression<br>* core decompression procedure only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC Score |  | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression defined as progression to a fractural stage of osteonecrosis |  | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteonecrosis, bone marrow, core decompression, femoral head