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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01756144
Recruitment Status : Unknown
Verified May 2015 by Dr Jan Vanderstappen, Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Not yet recruiting
First Posted : December 25, 2012
Last Update Posted : May 28, 2015
Information provided by (Responsible Party):
Dr Jan Vanderstappen, Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment Phase
Pseudarthrosis Device: rhBMP-2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport
Study Start Date : July 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Active Comparator: Autologous bone grafting
autologous bone of the iliac crest
Device: rhBMP-2
Experimental: rhBMP-2
Inductos, recombinant human bone morphogenetic protein
Device: rhBMP-2

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

Secondary Outcome Measures :
  1. Infection [ Time Frame: up to one year ]
  2. Edema [ Time Frame: up to one year ]
  3. cancer [ Time Frame: up to one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients treated with bone transport (Ilizarov technique) and have non-union of the docking site, which is characterized by absence of bridging callus after two months of compression in the docking site.

Exclusion Criteria:

  • Allergy for inductos
  • active growth,
  • malignancy
  • infection
  • PAD
  • pathological fracture
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Responsible Party: Dr Jan Vanderstappen, MD, Universitaire Ziekenhuizen Leuven Identifier: NCT01756144    
Other Study ID Numbers: 2012-005664-10
First Posted: December 25, 2012    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Fractures, Ununited
Fractures, Bone
Wounds and Injuries