The study, coordinated by the Johns Hopkins Bloomberg School of Public Health, was conducted at the University of Maryland Shock Trauma Center and seven other trauma centers across the country. It found that while patients who undergo reconstructive surgery have a higher risk of complications, additional surgeries, and hospitalizations, they fared about the same as those patients who have a leg amputated. After two years, both groups had similarly high levels of disability and psychological distress, and only about half of the people in each group were able to return to work.
"This research is important because limb reconstruction has become the treatment of choice in many trauma centers. There was mounting evidence, however, to suggest that functional outcomes were often poorer after reconstruction and that patients recovered more quickly with early amputation and a good prosthesis. Our research shows that there is no significant difference," said Ellen J. MacKenzie, Ph.D., professor of health policy and management and director of the Center for Injury Research and Policy at the Johns Hopkins Bloomberg School of Public Health and a co-principal investigator for the study. "This is the first large, prospective study to address this controversy in trauma orthopaedics."
As a result of their findings, researchers conclude that surgeons should continue their efforts to repair severely injured legs. "Everything else being equal, most patients would choose to keep their leg. Now we can advise patients that limb reconstruction at major trauma centers typically results in two-year outcomes equivalent to those of amputation," said Alan L. Jones, M.D., the chief of trauma orthopaedic surgery at the University of Maryland Shock Trauma Center and an investigator in the study.
"The study clearly demonstrates that these types of injuries and surgeries have a major impact on people's lives. Two years later, more than 40 percent of the patients in each group were still severely disabled. Only half of those were able to go back to work. We need to do more to help them recover emotionally and vocationally, as well as physically," said Dr. Jones, who is also an associate professor of orthopaedics at the University of Maryland School of Medicine.
More than 100 of the 569 patients enrolled in the study from 1994 to 1997 were treated at the University of Maryland Shock Trauma Center. The research was funded by a grant from the National Institute for Arthritis Musculoskeletal and Skin Diseases of the National Institutes of Health.
As part of the study, researchers also found that factors not related to the patient's injury or medical care significantly affected their recovery. These factors included education, income, race, whether patients smoked, had private health insurance, a strong social-support network and confidence in their ability to resume a normal life, or were involved in disability-compensation litigation. Those patients with support from family and friends had better outcomes than those who did not, Dr. Jones said.
"Future efforts to improve the results of either treatment should focus on eliminating complications following surgery and placing greater emphasis on non-clinical interventions, such as early evaluation and treatment by psychosocial and vocational rehabilitation specialists," said Dr. MacKenzie. She stressed the need to boost patients' confidence in their ability to resume their daily activities.
Researchers documented patients' injuries and treatment and evaluated their recovery using an extensive battery of outcome measures that included the Sickness Impact Profile, an assessment of a patient's functional ability. Patients provided information about their emotional behavior and alertness and their ability to walk and move, take care of themselves, interact socially with others, communicate, sleep and rest, eat, work, manage their homes, and take part in recreational activities.
In addition to the University of Maryland Shock Trauma Center, the trauma centers participating in the study included Carolinas Medical Center in Charlotte, N.C., Wake Forest University Baptist Medical Center in Winston-Salem, N.C., Harborview Medical Center in Seattle, Wash., Vanderbilt University School of Medicine in Nashville, Tenn., Cleveland MetroHealth Medical Center in Cleveland, Ohio, University of Texas Southwestern Medical Center in Dallas, Texas, and Tampa General Hospital in Tampa, Fla.
Renan Castillo, M.S., with the Johns Hopkins Bloomberg School of Public Health's Center for Injury Research and Policy, and Melissa L. McCarthy, Sc.D., with the Johns Hopkins School of Medicine, co-authored the study.
Additional authors were Michael J. Bosse, M.D., James F. Kellam, M.D., Andrew R. Burgess, M.D., Lawrence X. Webb, M.D., Marc F. Swiontkowski, M.D., Roy W. Sanders, M.D., Mark P. McAndrew, M.D., Brendan M. Patterson, M.D., and Thomas G. Travison, Ph.D.
Journal
New England Journal of Medicine