Text Size

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

This study is not yet open for participant recruitment.
Verified December 2012 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Dr Jan Vanderstappen, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01756144
First received: December 12, 2012
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  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
Bone Healing
Bone Morphogenetic Proteins
Bone Transport
 Device: rhBMP-2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Bone Grafts
U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Bone healing in the docking site [ Time Frame: up to 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Infection [ Time Frame: up to one year ] [ Designated as safety issue: Yes ]
  • Edema [ Time Frame: up to one year ] [ Designated as safety issue: Yes ]
  • cancer [ Time Frame: up to one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: February 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2015 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Dr Jan Vanderstappen, MD, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01756144     History of Changes
Other Study ID Numbers: 2012-005664-10
Study First Received: December 12, 2012
Last Updated: December 19, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

ClinicalTrials.gov processed this record on May 23, 2013