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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
December 12, 2012
December 25, 2012
May 28, 2015
July 2015
January 2016   (Final data collection date for primary outcome measure)
Bone healing in the docking site [ Time Frame: up to 4 months ]
Same as current
Complete list of historical versions of study NCT01756144 on ClinicalTrials.gov Archive Site
  • Infection [ Time Frame: up to one year ]
  • Edema [ Time Frame: up to one year ]
  • cancer [ Time Frame: up to one year ]
Same as current
Not Provided
Not Provided
 
rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport
rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pseudarthrosis
Device: rhBMP-2
  • Active Comparator: Autologous bone grafting
    autologous bone of the iliac crest
    Intervention: Device: rhBMP-2
  • Experimental: rhBMP-2
    Inductos, recombinant human bone morphogenetic protein
    Intervention: Device: rhBMP-2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
April 2016
January 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01756144
2012-005664-10
Yes
Not Provided
Not Provided
Dr Jan Vanderstappen, Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Not Provided
Universitaire Ziekenhuizen Leuven
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP