Clinical Trial: Controlled Study of Stage 3 Osteonecrosis Treatment by Bone Marrow

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: University Hospital of Liege

Current Primary Outcome: reduction of total prosthesis [ Time Frame: 24, 60 months ]

Need to undergo a surgical treatment total prosthesis


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain reduction [ Time Frame: 24, 60 months ]
    Visual analogue scale
  • functional status [ Time Frame: 24, 60 months ]
    Lequesne and WOMAC scores


Original Secondary Outcome: Same as current

Information By: University Hospital of Liege

Dates:
Date Received: February 22, 2012
Date Started: August 2004
Date Completion:
Last Updated: March 5, 2012
Last Verified: February 2012