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 Intervention Model: Parallel Assignment Masking: Double Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Osteonecrosis

U.S. FDA Resources

Further study details as provided by Jean-Philippe Hauzeur, University Hospital of Liege:

Primary Outcome Measures:

reduction of total prosthesis [ Time Frame: 24, 60 months ]
Need to undergo a surgical treatment total prosthesis

Secondary Outcome Measures:

Pain reduction [ Time Frame: 24, 60 months ]
Visual analogue scale
functional status [ Time Frame: 24, 60 months ]
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)
Sexes Eligible for Study:	All
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.

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


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

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

ClinicalTrials.gov processed this record on June 23, 2017

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