Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow
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ClinicalTrials.gov Identifier: NCT01544712 |
Recruitment Status
:
Completed
First Posted
: March 6, 2012
Last Update Posted
: March 6, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Traumatic Osteonecrosis of the Femoral Head (Hip) | Procedure: core decompression with autologous bone marrow implantation Procedure: core decompression of the femoral head | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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 |
Study Start Date : | August 2004 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | September 2010 |

Arm | Intervention/treatment |
---|---|
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.
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Experimental: Bone marrow
core decompression plus autologous concentrated bone marrow
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Procedure: core decompression with autologous bone marrow implantation
core biopsy with injection of 40 ml concentrated autologous bone marrow.
|
- reduction of total prosthesis [ Time Frame: 24, 60 months ]Need to undergo a surgical treatment total prosthesis
- Pain reduction [ Time Frame: 24, 60 months ]Visual analogue scale
- functional status [ Time Frame: 24, 60 months ]Lequesne and WOMAC scores

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544712
Belgium | |
University of Liège | |
Liège, Belgium, 4000 |
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 |
First Posted: | March 6, 2012 Key Record Dates |
Last Update Posted: | March 6, 2012 |
Last Verified: | February 2012 |
Keywords provided by Jean-Philippe Hauzeur, 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 |