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Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow

This study has been completed.
Sponsor:
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
History of Changes
  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:

U.S. FDA Resources

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
Genders Eligible for Study:   Both
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
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

No publications provided

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 May 16, 2013