Posted on March 20: Researcher initiates clinical trials on fractures of the tibia

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[img_inline align=”right” src=”http://padnws01.mcmaster.ca/images/bhandari_mohit_opt.jpg” caption=”Mohit Bhandari”]Mohit Bhandari, orthopedic surgeon and researcher at McMaster University, has initiated a large Canada/U.S. co-operative project to resolve differences of opinion on the best way to repair the most common long bone fracture in the human body – fracture of the tibia.

Fractures of the tibia, the larger big bone between the knee and the ankle, are one of the most common complications of serious trauma such as motor vehicle accidents.

Surgeons agree repair of serious tibial fractures should include the insertion of a nail into the canal within the central marrow cavity of the bone. They disagree, however, on whether it is better to enlarge (ream) the canal before inserting the nail.

Proponents believe reaming increases blood flow to the hard bone at the outer surface of the fracture site, thus increasing fracture repair stability. They also believe reaming provides a natural graft of the patient's own bone tissue at the fracture site.

Opponents believe that reaming damages the blood supply to the tissue lining the canal, impairing fracture healing.

The three-year study of the repair of fractures of the tibia will involve 1,200 patients with 105 participating surgeons at 10 centres in Canada, 12 centres in the U.S., and one center in the Netherlands. Bhandari and fellow McMaster investigator Gordon Guyatt, are heading up the Canadian trials, while Mark Swiontkowski, of the Minnisota Medical School, is leading the U.S. trials.

Nearly $3 million in funding is being provided by the Institute for Musculoskeletal Health and Arthritis (IMHA), a component of The Canadian Institutes for Health Research, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a component of the National Institutes of Health in the U.S.

Bhandari, who is internationally recognized as a leader in evidence-based orthopedic research, says, “Although there have been multiple small trails in tibial fracture care, large collaborative trials are new to orthopedic research. This initiative will move our methods a giant step ahead.”

During the study, patients who have a tibial fracture will be randomly assigned to either a reaming or nonreaming surgical group. Participants will be closely monitored and surgeons will examine participants at six, nine and 12 months.

Other factors will also be considered in determining which group has a more successful outcome, including how soon patients return to work and their general health status and quality of life.