Trial record 5 of 61 for:    Open Studies | "Bone Transplantation"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Northern Orthopaedic Division, Denmark
Sponsor:
Collaborators:
Medtronic
Center for Clinical and Basic Research (CCBR A/S).
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01690260
First received: September 12, 2012
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Bone Degenerative Changes
Osteoarthritis
Degenerative Disorder of Bone
Drug: Bone Morphogenetic Protein 2
Procedure: Autologous bone graft
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Bone Morphogenetic Protein-2 Increase as Substitute for Autologous Bone Graft After Ilizarow Treatment for Arthritis and Degenerative Bones.

Resource links provided by NLM:


Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • Visible radiological signs of healing after 6 months. [ Time Frame: An expected average of 6 months ] [ Designated as safety issue: No ]

    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:
  • Change in serologic bone markers [ Time Frame: An expected average of 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: September 2004
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Bone Morphogenetic Protein 2
12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1.
Other Name: No other names.
Procedure: Autologous bone graft
Autologous bone graft in connection with bone docking operation.
Other Name: No other names.
Experimental: 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.
Drug: Bone Morphogenetic Protein 2
12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1.
Other Name: No other names.
Procedure: Autologous bone graft
Autologous bone graft in connection with bone docking operation.
Other Name: No other names.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690260

Contacts
Contact: Knud Christensen, MD 99322595 ext 45 knsc@rn.dk
Contact: Sten Rasmussen, MD 99322367 ext 45 sten.rasmussen@rn.dk

Locations
Denmark
Orthopaedic Surgery Research Unit, Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Knud S. Christensen, MD    99322595 ext 45    knsc@rn.dk   
Contact: Susanne Joelck, Nurse    99322608 ext 45    s.joelck@rn.dk   
Principal Investigator: Knud S. Christensen, MD         
Sub-Investigator: Susanne Joelck, Nurse         
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Medtronic
Center for Clinical and Basic Research (CCBR A/S).
Investigators
Principal Investigator: Knud S. Christensen, MD Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
Study Chair: David Donnell, Advisor Medtronic Inc., Watford
Study Chair: Hans H. Hoeck, MD, Ph.D. Center for Clinical and Basic Research, Aalborg, Denmark (CCBR A/S)
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT01690260     History of Changes
Other Study ID Numbers: N-20040019
Study First Received: September 12, 2012
Last Updated: March 28, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:
Bone
Morphogenetic
Protein
Ilizarow
Autologous
Osteoarthritis

Additional relevant MeSH terms:
Bone Diseases
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 29, 2014