Overview

This trial is active, not recruiting.

Conditions bone degenerative changes, osteoarthritis, degenerative disorder of bone
Treatments bone morphogenetic protein 2, autologous bone graft
Phase phase 1
Sponsor Northern Orthopaedic Division, Denmark
Collaborator Medtronic
Start date September 2004
End date December 2015
Trial size 40 participants
Trial identifier NCT01690260, N-20040019

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Condition of bone healing will be evaluated at serial radiological examinations and by clinical results according to a standard score system.
bone morphogenetic protein 2 No other names.
12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1.
autologous bone graft No other names.
Autologous bone graft in connection with bone docking operation.
(Experimental)
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.
bone morphogenetic protein 2 No other names.
12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1.
autologous bone graft No other names.
Autologous bone graft in connection with bone docking operation.

Primary Outcomes

Measure
Visible radiological signs of healing after 6 months.
time frame: An expected average of 6 months

Secondary Outcomes

Measure
Change in serologic bone markers
time frame: An expected average of 6 months

Eligibility Criteria

Male or female participants from 20 years up to 70 years old.

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

Additional Information

Official title Bone Morphogenetic Protein-2 Increase as Substitute for Autologous Bone Graft After Ilizarow Treatment for Arthritis and Degenerative Bones.
Principal investigator Knud S. Christensen, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Northern Orthopaedic Division, Denmark.