Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow

NCT01544712 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-03-06

No results posted yet for this study

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

  • Non Traumatic Osteonecrosis of the Femoral Head (Hip)

Interventions

PROCEDURE

core decompression with autologous bone marrow implantation

core biopsy with injection of 40 ml concentrated autologous bone marrow.

PROCEDURE

core decompression of the femoral head

core biopsy with injection of 40 ml saline solution in place of bone marrow.

Sponsors & Collaborators

  • University of Liege

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01544712 on ClinicalTrials.gov