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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01690260

Enrollment

Registered

2012-09-21

Start date

2004-09-30

Completion date

2017-10-02

Last updated

2017-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Degenerative Changes, Degenerative Disorder of Bone, Osteoarthritis

Keywords

Bone, Morphogenetic, Protein, Ilizarow, Autologous, Osteoarthritis

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.

Interventions

DRUGBone Morphogenetic Protein 2

12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1.

PROCEDUREAutologous bone graft

Autologous bone graft in connection with bone docking operation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026