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

Pseudarthrosis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pseudarthrosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:rhBMP-2

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Autologous bone graftingautologous bone of the iliac crest

rhBMP-2Inductos, recombinant human bone morphogenetic protein

Study Status

Unknown status

Start Date: July 2015

Completed Date: April 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Bone healing in the docking site

Secondary Outcome: Infection

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Universitaire Ziekenhuizen Leuven

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01756144

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