Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow

March 5, 2012 updated by: Jean-Philippe Hauzeur, University of Liege

Treatment of Stage 3 Osteonecrosis of the Femoral Head by Autologous Transplantation of Bone Marrow Cells: a Randomized, Controlled Double Blind Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • University of Liège

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction of total prosthesis
Time Frame: 24, 60 months
Need to undergo a surgical treatment total prosthesis
24, 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain reduction
Time Frame: 24, 60 months
Visual analogue scale
24, 60 months
functional status
Time Frame: 24, 60 months
Lequesne and WOMAC scores
24, 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

February 22, 2012

First Submitted That Met QC Criteria

March 5, 2012

First Posted (ESTIMATE)

March 6, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2012

Last Update Submitted That Met QC Criteria

March 5, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ref 2004/08 st 3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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