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

October 4, 2017 updated by: Northern Orthopaedic Division, Denmark

Bone Morphogenetic Protein-2 Increase as Substitute for Autologous Bone Graft After Ilizarow Treatment for Arthritis and Degenerative Bones.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Orthopaedic Surgery Research Unit, Aalborg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Bone Morphogenetic Protein 2
12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1.
Other Names:
  • No other names.
Procedure: Autologous bone graft
Autologous bone graft in connection with bone docking operation.
Other Names:
  • No other names.
EXPERIMENTAL: 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.
Drug: Bone Morphogenetic Protein 2
12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1.
Other Names:
  • No other names.
Procedure: Autologous bone graft
Autologous bone graft in connection with bone docking operation.
Other Names:
  • No other names.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visible radiological signs of healing after 6 months.
Time Frame: An expected average of 6 months

Radiological signs of healing is a criteria for a successful result.

Failure of healing after 6 months and/or a need for stimulant bone healing intervention can result in:

  • Dynamic measurement af immobilization
  • Ultrasound stimulation
  • Re-surgery with application of bone graft or bone replacement
An expected average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serologic bone markers
Time Frame: An expected average of 6 months
Blood tests will be analyzed 1,2,3,4,6,9 and 12 months after operation in order to registrating a change in serologic bone markers.
An expected average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Orthopaedic Division, Denmark

Collaborators

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

Investigators

  • Principal Investigator: Knud S. Christensen, MD, Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
  • Study Chair: David Donnell, Advisor, Medtronic Inc., Watford
  • Study Chair: Hans H. Hoeck, MD, Ph.D., Center for Clinical and Basic Research, Aalborg, Denmark (CCBR A/S)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2004

Primary Completion (ACTUAL)

October 2, 2017

Study Completion (ACTUAL)

October 2, 2017

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

September 17, 2012

First Posted (ESTIMATE)

September 21, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2017

Last Update Submitted That Met QC Criteria

October 4, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20040019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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