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?
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.
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
Start Date: July 2015
Completed Date: April 2016
Primary Outcome: Bone healing in the docking site
Secondary Outcome: Infection
Study sponsors, principal investigator, and references
Lead Sponsor: Universitaire Ziekenhuizen Leuven