Status:
WITHDRAWN
A Randomized Controlled Cost Study of Infuse BMP 2 vs Iliac Crest Autograft for Non Union of Long Bone Fractures
Lead Sponsor:
Ross Leighton
Collaborating Sponsors:
Canadian Orthopaedic Trauma Society
Conditions:
Non Union Diaphyseal Fractures
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
We are inviting individuals such as yourself, who have diaphyseal fracture (broken bone) with a non union to participate in this research study. A non-union is a lack of bone healing (bone growth wher...
Detailed Description
We propose a multi-centre Canadian randomized Study wherein 80 patients are randomized (put in groups by no standard pattern ie. flipping a coin) to receive both autograft (sample of your own bone: il...
Eligibility Criteria
Inclusion
- Patients must meet all of the following criteria to be eligible for entry into the study:
- a) Patients must require open surgical treatment of non-union of a diaphyseal fracture of the tibia, humerus, femur, radius or ulna sustained secondary to trauma.
- c) Patients must be candidates for surgical treatment with an intramedullary nail or locked or unlocked plate.
- d) Patients must have a fracture of the diaphysis as defined for that specific bone.
- e) Patients must show radiographic evidence of skeletal maturity (closed epiphyseal plates).
Exclusion
- Patients with any of the following criteria, are not eligible for entry into the study:
- Patients requiring mechanical fixation other than Intramedullary nailing or plating (i.e. no external fixation)
- Patients with fractures that fall outside the diaphysis defined for the specific bone in question, i.e. no metaphyseal fractures.
- Patients with segmental circumferential bone loss \>4cm.
- Patients whose fractures are the result of a tumour
- Infection per se, does not result in exclusion but it must be treated and the soft tissue envelope closed prior to randomization
- Patients with known metabolic bone disease (other than osteoporosis) which would negatively impact on the bone healing process.
- Patients with known sensitivity to collagen.
- Patients who are pregnant or breastfeeding at the time of study enrolment.
- Patients currently being treated with radiation, chemotherapy, immunosuppression, or steroid therapy.
- Patients receiving any other investigational drug or treatment.
- Patients who have other injuries or conditions such as they are unable to communicate or consent
- m)Patients with known breast or prostate cancer
- f) Patients must be able and willing to provide informed consent, to complete study assessments, and to be followed for the period of the study.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00856479
Start Date
March 1 2009
End Date
March 1 2013
Last Update
November 14 2022
Active Locations (1)
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1
Halifax Infirmary
Halifax, Nova Scotia, Canada, B3h 1V7