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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01756144

Enrollment

Registered

2012-12-25

Start date

2015-07-31

Completion date

2016-04-30

Last updated

2015-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pseudarthrosis

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.

Interventions

DEVICErhBMP-2

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Bone healing in the docking site	up to 4 months

Secondary

Measure	Time frame
Infection	up to one year
Edema	up to one year
cancer	up to one year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026