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
  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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 29, 2014