rhBMP-2 vs Autologous Bone Grafting for the Treatment of... | NCT01756144

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

NCT01756144

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Unknown status

Last Update Posted

May 28, 2015Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Pseudarthrosis

Interventions

rhBMP-2

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Jan 2016Estimated

Completion Date

Apr 2016Estimated

First Submitted Date

Dec 12, 2012

First Submission Date that Met QC Criteria

Dec 19, 2012

First Posted Date

Dec 25, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2015

Last Update Posted Date

May 28, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Jan Vanderstappen, MD, Universitaire Ziekenhuizen KU LeuvenPrincipal Investigator

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
rhBMP-2	Device		Autologous bone grafting rhBMP-2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Infection		up to one year
Edema		up to one year
cancer

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011542	Pseudarthrosis

Ancestor Terms

ID	Term
D005599	Fractures, Ununited
D050723	Fractures, Bone
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided