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

NCT01690260 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2017-10-05

No results posted yet for this study

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.

Conditions

  • Bone Degenerative Changes
  • Osteoarthritis
  • Degenerative Disorder of Bone

Interventions

DRUG

Bone Morphogenetic Protein 2

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

PROCEDURE

Autologous bone graft

Autologous bone graft in connection with bone docking operation.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

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

    collaborator UNKNOWN

  • Northern Orthopaedic Division, Denmark

    lead OTHER

Principal Investigators

  • Knud S. Christensen, MD · Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

  • David Donnell, Advisor · Medtronic Inc., Watford

  • Hans H. Hoeck, MD, Ph.D. · Center for Clinical and Basic Research, Aalborg, Denmark (CCBR A/S)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2017-10-02
Completion
2017-10-02

Countries

  • Denmark

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01690260 on ClinicalTrials.gov