Clinical Trials Directory

Trials / Completed

CompletedNCT01544712

Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
University of Liege · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREcore decompression with autologous bone marrow implantationcore biopsy with injection of 40 ml concentrated autologous bone marrow.
PROCEDUREcore decompression of the femoral headcore biopsy with injection of 40 ml saline solution in place of bone marrow.

Timeline

Start date
2004-08-01
Primary completion
2010-09-01
Completion
2010-09-01
First posted
2012-03-06
Last updated
2012-03-06

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT01544712. Inclusion in this directory is not an endorsement.