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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 recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Dr Jan Vanderstappen, Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01756144
First Posted: December 25, 2012
Last Update Posted: May 28, 2015
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.
Information provided by (Responsible Party):
Dr Jan Vanderstappen, Universitaire Ziekenhuizen Leuven
  Purpose

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 Intervention
Pseudarthrosis Device: rhBMP-2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dr Jan Vanderstappen, Universitaire Ziekenhuizen Leuven:

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

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

Estimated Enrollment: 20
Study Start Date: July 2015
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Dr Jan Vanderstappen, MD, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01756144     History of Changes
Other Study ID Numbers: 2012-005664-10
First Submitted: December 12, 2012
First Posted: December 25, 2012
Last Update Posted: May 28, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Pseudarthrosis
Fractures, Ununited
Fractures, Bone
Wounds and Injuries


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