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

Northern Orthopaedic Division, Denmark

Status and phase: Completed; Phase 1

Conditions: Osteoarthritis; Bone Degenerative Changes; Degenerative Disorder of Bone

Treatments: Procedure: Autologous bone graft; Drug: Bone Morphogenetic Protein 2

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01690260

N-20040019

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 2 patient groups

Bone Morphogenetic Protein 2

Experimental group

Description:

Condition of bone healing will be evaluated at serial radiological examinations and by clinical results according to a standard score system.

Treatment:

Drug: Bone Morphogenetic Protein 2

Procedure: Autologous bone graft

Autologous bone graft

Experimental group

Description:

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.

Treatment:

Drug: Bone Morphogenetic Protein 2

Procedure: Autologous bone graft