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Surgeons agree that 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 of reaming believe reaming increases blood flow to the hard bone at the outer surface of the fracture site, thus increasing fracture 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.
During the study, patients who have a tibial fracture will be randomly assigned to either a reaming or nonreaming surgical group. At six weeks, three months, six months, nine months, and one year, surgeons will examine participants to determine whether the operation was successful or whether they require additional surgery to promote fracture healing. These operations would include a bone graft, exchange or removal of the nail, removal of the locking screws, or procedures to treat soft tissue infections or defects. Other factors will 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.
Stephen I. Katz, M.D., Ph.D., director of the NIAMS, says, "A large multicenter clinical trial of this kind involving U.S. physicians and physicians of our neighbor, Canada, is a good example of cooperation between two countries to improve medical practice. This project will provide the most reliable information to date on the best surgical procedure to promote the healing of tibial fractures. Surgeons will be able to operate with greater certainty that they are following a state-of-the-art practice for repair of these fractures."
The principal investigators for the trial are Marc F. Swiontkowski, M.D., at the University of Minnesota Medical School in Minneapolis (U.S. sites) and Gordon H. Guyatt, M.D., M.Sc., at McMaster University in Hamilton, Ontario (Canadian and European sites). Data from all sites are being coordinated at McMaster University.
Participating centers are:
The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (United States) is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases, the training of basic and clinical scientists to carry out this research, and the dissemination of information on research progress in these diseases. For more information about NIAMS, please call (301) 495-4484 or (877) 22-NIAMS (free call) or visit the NIAMS Web site at www.niams.nih.gov.
The mission of the Institute of Musculoskeletal Health and Arthritis (Canada) is to excel, according to internationally accepted standards of scientific excellence, in the creation of new knowledge in all areas relevant to arthritis, rehabilitation, bone, muscle, skin, and oral health, and to translate that new knowledge into improved health for Canadians, more effective health services and products, and a strengthened Canadian health care system. For more information about IMHA, please call (403) 220-3521 or visit the IMHA Web site at: www.cihr-irsc.gc.ca/institutes/imha/index_e.shtml.
To contact Dr. Swiontkowski, call Sarah Youngerman at the University of Minnesota Medical
School at (612) 624-4604.
To contact Dr. Guyatt, call Deborah Maddock at McMaster University Health Sciences Centre at (905) 525-9140, x22900.