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. (see Contacts and Locations)
Verified May 2015 by Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Dr Jan Vanderstappen, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
First received: December 12, 2012
Last updated: May 26, 2015
Last verified: May 2015

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
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:

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: 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


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 26, 2015
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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

ClinicalTrials.gov processed this record on December 01, 2015