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Parallel Study Between BMP-2 and Autologous Bone Graft After Ilizarow Treatment

NCT ID: NCT01690260

Last Updated: 2017-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2017-10-02

Brief Summary

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Results of growth factors indicate that Bone Morphogenetic Proteins (BMP) have an exceptional ability to stimulate different characteristics of mesenchymale cells to osseous cells. Local application of BMP results in an increase of osseous tissue regardless of the location of the growth factor.

5 years clinical studies show that BMP's can stimulate an increase of osseous tissue and improve clinical results when autologous bone graft is reduced or removed.

The purpose of this study is to examine whether recombinant growth factor BMP-2 can replace autologous bone graft in order to stimulating ossification during transplantation of osseous tissue.

Detailed Description

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Conditions

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Bone Degenerative Changes Osteoarthritis Degenerative Disorder of Bone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bone Morphogenetic Protein 2

Condition of bone healing will be evaluated at serial radiological examinations and by clinical results according to a standard score system.

Group Type EXPERIMENTAL

Bone Morphogenetic Protein 2

Intervention Type DRUG

12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1.

Autologous bone graft

Intervention Type PROCEDURE

Autologous bone graft in connection with bone docking operation.

Autologous bone graft

Condition of bone healing will be evaluated at serial radiological examinations after 1,2,3,4,5,6,9 and 12 months. Blood tests and urine samples will also be examined for monitoring the bone healing process.

Group Type EXPERIMENTAL

Bone Morphogenetic Protein 2

Intervention Type DRUG

12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1.

Autologous bone graft

Intervention Type PROCEDURE

Autologous bone graft in connection with bone docking operation.

Interventions

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Bone Morphogenetic Protein 2

12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1.

Intervention Type DRUG

Autologous bone graft

Autologous bone graft in connection with bone docking operation.

Intervention Type PROCEDURE

Other Intervention Names

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No other names. No other names.

Eligibility Criteria

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Inclusion Criteria

* Hospitalised for autologous bone graft based on Ilizarow treatment.
* Age between 20 and 70 years.

Exclusion Criteria

* Rheumatoid osteoarthritis
* Malignant disease
* Current hormone treatment (glucocorticoid, parathyreoidea, thyreoidea)
* Pregnancy
* Abuse of drugs and alcohol
* Need of long-term NSAID treatment
* Breastfeeding women
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Center for Clinical and Basic Research (CCBR A/S).

UNKNOWN

Sponsor Role collaborator

Northern Orthopaedic Division, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Knud S. Christensen, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

David Donnell, Advisor

Role: STUDY_CHAIR

Medtronic Inc., Watford

Hans H. Hoeck, MD, Ph.D.

Role: STUDY_CHAIR

Center for Clinical and Basic Research, Aalborg, Denmark (CCBR A/S)

Locations

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Orthopaedic Surgery Research Unit, Aalborg University Hospital

Aalborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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N-20040019

Identifier Type: -

Identifier Source: org_study_id