Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow
NCT01544712 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2012-03-06
Summary
In stage 3 Osteonecrosis (ON) of the femoral head, a beneficial effect of bone marrow grafting was reported with a reduction of the functional evolution and the necessity of a total prosthesis placement in a non-controlled retrospective trial. Based on this experience, the investigators would like to start a randomized controlled double blind study on the effect of autologous implantation of autologous bone marrow cells into the necrotic lesion of stage 3 ON of the femoral head.
Conditions
- Non Traumatic Osteonecrosis of the Femoral Head (Hip)
Interventions
- PROCEDURE
-
core decompression with autologous bone marrow implantation
core biopsy with injection of 40 ml concentrated autologous bone marrow.
- PROCEDURE
-
core decompression of the femoral head
core biopsy with injection of 40 ml saline solution in place of bone marrow.
Sponsors & Collaborators
-
University of Liege
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-08-31
- Primary Completion
- 2010-09-30
- Completion
- 2010-09-30
Countries
- Belgium
Study Locations
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