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

Primary Purpose

Pseudarthrosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
rhBMP-2
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pseudarthrosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Autologous bone grafting

    rhBMP-2

    Arm Description

    autologous bone of the iliac crest

    Inductos, recombinant human bone morphogenetic protein

    Outcomes

    Primary Outcome Measures

    Bone healing in the docking site

    Secondary Outcome Measures

    Infection
    Edema
    cancer

    Full Information

    First Posted
    December 12, 2012
    Last Updated
    May 26, 2015
    Sponsor
    Universitaire Ziekenhuizen KU Leuven
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01756144
    Brief Title
    rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport
    Official Title
    rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    January 2016 (Anticipated)
    Study Completion Date
    April 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitaire Ziekenhuizen KU Leuven

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pseudarthrosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Autologous bone grafting
    Arm Type
    Active Comparator
    Arm Description
    autologous bone of the iliac crest
    Arm Title
    rhBMP-2
    Arm Type
    Experimental
    Arm Description
    Inductos, recombinant human bone morphogenetic protein
    Intervention Type
    Device
    Intervention Name(s)
    rhBMP-2
    Primary Outcome Measure Information:
    Title
    Bone healing in the docking site
    Time Frame
    up to 4 months
    Secondary Outcome Measure Information:
    Title
    Infection
    Time Frame
    up to one year
    Title
    Edema
    Time Frame
    up to one year
    Title
    cancer
    Time Frame
    up to one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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