A Randomized Controlled Cost Study of Infuse BMP 2 vs Iliac Crest Autograft for Non Union of Long Bone Fractures (Infuse)
Non Union Diaphyseal Fractures
About this trial
This is an interventional treatment trial for Non Union Diaphyseal Fractures focused on measuring Infuse, cost analysis, Non union diaphyseal fracture, The efficacy of Infuse BMP 2 in Non union diaphyseal fractures. Also the cost analysis with the amount of time spent in hospital post op.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Sites / Locations
- Halifax Infirmary
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
1 Infuse
2 Iliac crest autograft
The patient will receive BMP 2 with allograft
Autograft from Patients Iliac Crest and allograft