NCT01756144

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 25, 2012

Completed
2.5 years until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

6 months

First QC Date

December 12, 2012

Last Update Submit

May 26, 2015

Conditions

Pseudarthrosis

Outcome Measures

Primary Outcomes (1)

  • Bone healing in the docking site

    up to 4 months

Secondary Outcomes (3)

  • Infection

    up to one year

  • Edema

    up to one year

  • cancer

    up to one year

Study Arms (2)

Autologous bone grafting

ACTIVE COMPARATOR

autologous bone of the iliac crest

Device: rhBMP-2

rhBMP-2

EXPERIMENTAL

Inductos, recombinant human bone morphogenetic protein

Device: rhBMP-2

Interventions

rhBMP-2DEVICE
Autologous bone graftingrhBMP-2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Allergy for inductos
  • active growth,
  • malignancy
  • infection
  • PAD
  • pathological fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pseudarthrosis

Condition Hierarchy (Ancestors)

Fractures, UnunitedFractures, BoneWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 12, 2012

First Posted

December 25, 2012

Study Start

July 1, 2015

Primary Completion

January 1, 2016

Study Completion

April 1, 2016

Last Updated

May 28, 2015

Record last verified: 2015-05