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

Primary Purpose

Bone Degenerative Changes, Osteoarthritis, Degenerative Disorder of Bone

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Bone Morphogenetic Protein 2
Autologous bone graft
Sponsored by
Northern Orthopaedic Division, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Degenerative Changes focused on measuring Bone, Morphogenetic, Protein, Ilizarow, Autologous, Osteoarthritis

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Orthopaedic Surgery Research Unit, Aalborg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bone Morphogenetic Protein 2

Autologous bone graft

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Visible radiological signs of healing after 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

Change in serologic bone markers
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.

Full Information

First Posted
September 12, 2012
Last Updated
October 4, 2017
Sponsor
Northern Orthopaedic Division, Denmark
Collaborators
Medtronic, Center for Clinical and Basic Research (CCBR A/S).
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1. Study Identification

Unique Protocol Identification Number
NCT01690260
Brief Title
Parallel Study Between BMP-2 and Autologous Bone Graft After Ilizarow Treatment
Official Title
Bone Morphogenetic Protein-2 Increase as Substitute for Autologous Bone Graft After Ilizarow Treatment for Arthritis and Degenerative Bones.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2004 (Actual)
Primary Completion Date
October 2, 2017 (Actual)
Study Completion Date
October 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern Orthopaedic Division, Denmark
Collaborators
Medtronic, Center for Clinical and Basic Research (CCBR A/S).

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Degenerative Changes, Osteoarthritis, Degenerative Disorder of Bone
Keywords
Bone, Morphogenetic, Protein, Ilizarow, Autologous, Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bone Morphogenetic Protein 2
Arm Type
Experimental
Arm Description
Condition of bone healing will be evaluated at serial radiological examinations and by clinical results according to a standard score system.
Arm Title
Autologous bone graft
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Bone Morphogenetic Protein 2
Other Intervention Name(s)
No other names.
Intervention Description
12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1.
Intervention Type
Procedure
Intervention Name(s)
Autologous bone graft
Other Intervention Name(s)
No other names.
Intervention Description
Autologous bone graft in connection with bone docking operation.
Primary Outcome Measure Information:
Title
Visible radiological signs of healing after 6 months.
Description
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
Time Frame
An expected average of 6 months
Secondary Outcome Measure Information:
Title
Change in serologic bone markers
Description
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.
Time Frame
An expected average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Knud S. Christensen, MD
Organizational Affiliation
Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Donnell, Advisor
Organizational Affiliation
Medtronic Inc., Watford
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hans H. Hoeck, MD, Ph.D.
Organizational Affiliation
Center for Clinical and Basic Research, Aalborg, Denmark (CCBR A/S)
Official's Role
Study Chair
Facility Information:
Facility Name
Orthopaedic Surgery Research Unit, Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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