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Completed

NCT Number: NCT01690260

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

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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Key information

Conditions

Bone Degenerative Changes Arthritis Degenerative Disorder of Bone Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orthopaedic Surgery Research Unit, Aalborg University Hospital

Aalborg, 9000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone Morphogenetic Protein 2

Drug

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

Other names: No other names.

Autologous bone graft

Procedure

Autologous bone graft in connection with bone docking operation.

Other names: No other names.

Primary outcomes

  1. Visible radiological signs of healing after 6 months.

    Time frame: 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 outcomes

  1. Change in serologic bone markers

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northern Orthopaedic Division, Denmark

Other

Collaborators

  • Center for Clinical and Basic Research (CCBR A/S).
  • Medtronic

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2017
Study completion
2017
First posted
Sep 21, 2012
Registry last updated
Oct 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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