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

Universitaire Ziekenhuizen KU Leuven

Status: Unknown

Conditions: Pseudarthrosis

Treatments: Device: rhBMP-2

Study type: Interventional

Funder types: Other

Identifiers

NCT01756144

2012-005664-10

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Autologous bone grafting

Active Comparator group

Description:

autologous bone of the iliac crest

Treatment:

Device: rhBMP-2

rhBMP-2

Experimental group

Description:

Inductos, recombinant human bone morphogenetic protein

Treatment:

Device: rhBMP-2