Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow
This study has been completed.
Sponsor:
University Hospital of Liege
Information provided by (Responsible Party):
Jean-Philippe Hauzeur, University Hospital of Liege
ClinicalTrials.gov Identifier:
NCT01544712
First received: February 22, 2012
Last updated: March 5, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Non Traumatic Osteonecrosis of the Femoral Head (Hip) |
Procedure: core decompression with autologous bone marrow implantation Procedure: core decompression of the femoral head |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Treatment of Stage 3 Osteonecrosis of the Femoral Head by Autologous Transplantation of Bone Marrow Cells: a Randomized, Controlled Double Blind Study |
Resource links provided by NLM:
Further study details as provided by University Hospital of Liege:
Primary Outcome Measures:
- reduction of total prosthesis [ Time Frame: 24, 60 months ] [ Designated as safety issue: Yes ]Need to undergo a surgical treatment total prosthesis
Secondary Outcome Measures:
- Pain reduction [ Time Frame: 24, 60 months ] [ Designated as safety issue: Yes ]Visual analogue scale
- functional status [ Time Frame: 24, 60 months ] [ Designated as safety issue: Yes ]Lequesne and WOMAC scores
| Enrollment: | 50 |
| Study Start Date: | August 2004 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Control
Core decompression
|
Procedure: core decompression of the femoral head
core biopsy with injection of 40 ml saline solution in place of bone marrow.
|
|
Experimental: Bone marrow
core decompression plus autologous concentrated bone marrow
|
Procedure: core decompression with autologous bone marrow implantation
core biopsy with injection of 40 ml concentrated autologous bone marrow.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- patients who have a non traumatic ON of the femoral head
- Stage 3 ON (subchondral fracture).
- Age > 18 years
- Be able and willing to participate in the study
Exclusion Criteria:
- evidence of malignant disorder in the past five years
- Patient unable to undergo a MRI.
- Patient who is positive for an HIV, hepatitis B or C infection.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01544712
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544712
Locations
| Belgium | |
| University of Liège | |
| Liège, Belgium, 4000 | |
Sponsors and Collaborators
University Hospital of Liege
More Information
| Responsible Party: | Jean-Philippe Hauzeur, Principal investigator, University Hospital of Liege |
| ClinicalTrials.gov Identifier: | NCT01544712 History of Changes |
| Other Study ID Numbers: | Ref 2004/08 st 3 |
| Study First Received: | February 22, 2012 |
| Last Updated: | March 5, 2012 |
| Health Authority: | Belgium: Ethics Committee |
Keywords provided by University Hospital of Liege:
|
osteonecrosis cell-based therapy bone marrow |
mesenchymal stem cell hip core decompression |
Additional relevant MeSH terms:
|
Osteonecrosis Bone Diseases Musculoskeletal Diseases Necrosis Pathologic Processes |
ClinicalTrials.gov processed this record on September 28, 2016