NCT01690260

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2017

Completed
Last Updated

October 5, 2017

Status Verified

October 1, 2017

Enrollment Period

13.1 years

First QC Date

September 12, 2012

Last Update Submit

October 4, 2017

Conditions

Bone Degenerative ChangesOsteoarthritisDegenerative Disorder of Bone

Keywords

BoneMorphogeneticProteinIlizarowAutologousOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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

    An expected average of 6 months

Secondary Outcomes (1)

  • Change in serologic bone markers

    An expected average of 6 months

Study Arms (2)

Bone Morphogenetic Protein 2

EXPERIMENTAL

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 2Procedure: Autologous bone graft

Autologous bone graft

EXPERIMENTAL

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 2Procedure: Autologous bone graft

Interventions

Bone Morphogenetic Protein 2DRUG

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

Also known as: No other names.
Autologous bone graftBone Morphogenetic Protein 2
Autologous bone graftPROCEDURE

Autologous bone graft in connection with bone docking operation.

Also known as: No other names.
Autologous bone graftBone Morphogenetic Protein 2

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalised for autologous bone graft based on Ilizarow treatment.
  • Age between 20 and 70 years.

You may not qualify if:

  • Rheumatoid osteoarthritis
  • Malignant disease
  • Current hormone treatment (glucocorticoid, parathyreoidea, thyreoidea)
  • Pregnancy
  • Abuse of drugs and alcohol
  • Need of long-term NSAID treatment
  • Breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Surgery Research Unit, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Bone Morphogenetic Protein 2

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Bone Morphogenetic ProteinsTGF-beta Superfamily ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Knud S. Christensen, MD

    Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

  • 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)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2012

First Posted

September 21, 2012

Study Start

September 1, 2004

Primary Completion

October 2, 2017

Study Completion

October 2, 2017

Last Updated

October 5, 2017

Record last verified: 2017-10

Locations

DK(1)