WithdrawnPhase 4

A Randomized Controlled Cost Study of Infuse BMP 2 vs Iliac Crest Autograft for Non Union of Long Bone Fractures

Stopped: Study never started

Canada0Started 2009-03

Plain-language 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 where the break in the bone occurred) after 3 months after the operation. The diaphyseal is an area of a specific bone (usually near the middle) where the fracture occurred. The bones we are interested in are the clavicle (collar bone), tibia (lower leg), femur (upper leg), humerus (upper arm) and forearm (lower arm). Treatment goals for these types of fractures are to minimize later surgeries, to assist the healing process, and to decrease the time to healing. The ability of a patient with non-union (lack of bone healing after 3 months post operation) to return to the work force and to normal activities more quickly not only has a good financial impact on society (community), but also improves over-all physical and mental well-being of the patients. "Infuse" is a synthetic bone morphogenic protein which means it has the ability to help your bone to form and heal if inserted in the fracture site. "Infuse" may be the first commercially available product approved by Health Canada to accelerate the healing of long bone non-unions requiring surgical intervention. Although the safety and efficacy of Infuse has been demonstrated through numerous pre-clinical studies, further human clinical trial is needed to evaluate the safety and the power to produce effects of this product particularly with respect to non unions of long bones. The purpose of this study is to evaluate the safety and the power to produce effects of Infuse implanted during treatment of long bone non unions to reduce later surgeries required to augment the healing process and to accelerate the time to healing. Given this, the orthopaedic community has planned this study in order to scientifically establish the most effective treatment method to restore function after this type of injury.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. 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.

What they're measuring

cost analysis based on length of hospital stay, allograft, blood products and costs associated with complications and/ or re-admission.

Timeframe: 2 years

Trial details

NCT IDNCT00856479

SponsorRoss Leighton

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-03

View on ClinicalTrials.gov More Non Union Diaphyseal Fractures trials