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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
Sponsor:
Information provided by (Responsible Party):
Jean-Philippe Hauzeur, University Hospital of Liege

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

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 Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteonecrosis
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
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.


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. reduction of total prosthesis [ Time Frame: 24, 60 months ]
    Need to undergo a surgical treatment total prosthesis


Secondary Outcome Measures :
  1. Pain reduction [ Time Frame: 24, 60 months ]
    Visual analogue scale

  2. functional status [ Time Frame: 24, 60 months ]
    Lequesne and WOMAC scores


Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Inclusion Criteria:

  1. patients who have a non traumatic ON of the femoral head
  2. Stage 3 ON (subchondral fracture).
  3. Age > 18 years
  4. Be able and willing to participate in the study

Exclusion Criteria:

  1. evidence of malignant disorder in the past five years
  2. Patient unable to undergo a MRI.
  3. Patient who is positive for an HIV, hepatitis B or C infection.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Belgium
University of Liège
Liège, Belgium, 4000
Sponsors and Collaborators
University Hospital of Liege
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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