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

Phase 1

Completed

• Conditions: Bone Degenerative Changes; Osteoarthritis; Degenerative Disorder of Bone
• Interventions: Drug: Bone Morphogenetic Protein 2; Procedure: Autologous bone graft

• Registration Number: NCT01690260
• Lead Sponsor: Northern Orthopaedic Division, Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-21
• Status Verified: 2017-10
• Primary Completion: 2017-10-02
• Study Completion: 2017-10-02
• Last Update Submitted: 2017-10-04
• Last Update Posted: 2017-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bone Morphogenetic Protein 2	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.
Autologous bone graft	Bone Morphogenetic Protein 2	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	Autologous bone graft	Condition of bone healing will be evaluated at serial radiological examinations and by clinical results according to a standard score system.
Autologous bone graft	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.

Primary Outcome Measures

Name	Time	Method
Visible radiological signs of healing after 6 months.	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

Secondary Outcome Measures

Name	Time	Method
Change in serologic bone markers	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.

Trial Locations

Locations (1)

Orthopaedic Surgery Research Unit, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark