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

Study Overview
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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.

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

Conditions
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Bone Degenerative Changes, Osteoarthritis, Degenerative Disorder of Bone

Intervention / Treatment
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* Drug: Bone Morphogenetic Protein 2
* Procedure: Autologous bone graft


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bone Morphogenetic Protein 2<br>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<br>* 12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1.<br>* Other names: No other names.;Procedure: Autologous bone graft<br>* Autologous bone graft in connection with bone docking operation.<br>* Other names: No other names.;|
| Experimental: Autologous bone graft<br>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<br>* 12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1.<br>* Other names: No other names.;Procedure: Autologous bone graft<br>* Autologous bone graft in connection with bone docking operation.<br>* Other names: No other names.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visible radiological signs of healing after 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone, Morphogenetic, Protein, Ilizarow, Autologous, Osteoarthritis