Clinical Trial: rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport

Brief Summary:

When there is a bone defect, bone transport is used to bridge the defect. Frequently, the bone in the docking site (where the transported bone comes together) doesn't heal.

The objective is to study the effectivity of rhBmp-2 (inductos) to stimulate bone healing, in order to find new techniques to treat non-union of long bones.

The method of the study is a randomized controlled trial, to compare rhBMP-2 and autologous bone grafting in stimulating bone healing in the docking site.


Detailed Summary:
Sponsor: Universitaire Ziekenhuizen Leuven

Current Primary Outcome: Bone healing in the docking site [ Time Frame: up to 4 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Infection [ Time Frame: up to one year ]
  • Edema [ Time Frame: up to one year ]
  • cancer [ Time Frame: up to one year ]


Original Secondary Outcome: Same as current

Information By: Universitaire Ziekenhuizen Leuven

Dates:
Date Received: December 12, 2012
Date Started: July 2015
Date Completion: April 2016
Last Updated: May 26, 2015
Last Verified: May 2015