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

Universitaire Ziekenhuizen KU Leuven20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pseudarthrosis

Interventions

rhBMP-2DEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bone healing in the docking site

Time frame: up to 4 months

Secondary Outcomes

Infection

Time frame: up to one year

Edema

Time frame: up to one year

cancer

Time frame: up to one year

Data from ClinicalTrials.gov

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