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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| Center for Clinical and Basic Research (CCBR A/S). | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone Morphogenetic Protein 2 | Experimental | Condition of bone healing will be evaluated at serial radiological examinations and by clinical results according to a standard score system. |
|
| Autologous bone graft | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Morphogenetic Protein 2 | Drug | 12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1. |
|
| 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:
| An expected average of 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Knud S. Christensen, MD | Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark | Principal Investigator |
| 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 Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Surgery Research Unit, Aalborg University Hospital | Aalborg | 9000 | Denmark |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D055396 | Bone Morphogenetic Protein 2 |
| ID | Term |
|---|---|
| D019485 | Bone Morphogenetic Proteins |
| D055411 | TGF-beta Superfamily Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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|
| Autologous bone graft | Procedure | Autologous bone graft in connection with bone docking operation. |
|
|
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |