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

Not Applicable

• Conditions: Pseudarthrosis
• Interventions: Device: rhBMP-2

• Registration Number: NCT01756144
• Lead Sponsor: Universitaire Ziekenhuizen KU 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2012-12-19
• Study First Posted: 2012-12-25
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-28
• Study Start: 2015-07
• Primary Completion: 2016-01
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rhBMP-2	rhBMP-2	Inductos, recombinant human bone morphogenetic protein
Autologous bone grafting	rhBMP-2	autologous bone of the iliac crest

Primary Outcome Measures

Name	Time	Method
Bone healing in the docking site	up to 4 months

Secondary Outcome Measures

Name	Time	Method
Infection	up to one year
Edema	up to one year
cancer	up to one year