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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690260
• Other study ID #: N-20040019
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2012
• Last updated: October 4, 2017
• Start date: September 2004
• Est. completion date: October 2, 2017

Study information

• Verified date: October 2017
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 2, 2017
• Est. primary completion date: October 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Degenerative Changes
• Bone Diseases
• Degenerative Disorder of Bone
• Osteoarthritis

Intervention

Drug:
• Bone Morphogenetic Protein 2
12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1.

Procedure:
• Autologous bone graft
Autologous bone graft in connection with bone docking operation.

Locations

Country	Name	City	State
Denmark	Orthopaedic Surgery Research Unit, Aalborg University Hospital	Aalborg

Sponsors (3)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark	Center for Clinical and Basic Research (CCBR A/S)., Medtronic

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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