Wednesday, February 5, 2003
Thirteen investigators were presented with Kappa Delta's 2003 Ann Doner Vaughan Award for their research into limb salvage or amputation following severe lower extremity trauma, a study referred to as the LEAP Study.
Award recipients include
|Michael J. Bosse, MD|
of the department of orthopaedic surgery in the Carolinas Medical Center in Charlotte, N.C.
|Ellen J. MacKenzie, PhD|
of the Center for Injury Research and Policy,
Johns Hopkins University Bloomberg School of Hygiene and Public Health, Baltimore, Md.
|were the study's co-principal investigators.|
The LEAP Study was designed to explore multiple sub-hypotheses related to the care and outcome of the trauma patient with a severe lower extremity injury. Employing the power of a large prospective database, the LEAP Study has influenced the understanding of the injury, the treatment and the recovery pattern of patients with limb-threatening lower extremity injuries.
The project represents a more than 10-year collaboration that was initiated to investigate treatment outcomes after reconstruction or amputation.
The authors note that between 15,000 and 35,000 limb-threatening injuries occur each year in the U.S. and that the majority of the injuries are to the lower extremity. Most of these injuries occur in young patients.
In introducing their research, the authors note that, "limb salvage for severe lower extremity trauma has replaced amputation as the primary treatment in many trauma centers, but long-term patient outcomes after limb reconstruction or amputation have not been fully evaluated." The researchers, therefore, developed a multicenter, prospective, longitudinal outcomes study that was used to determine functional outcomes of 545 patients with severe lower limb injuries.
The principal functional outcome measure was the Sickness Impact Profile (SIP). Secondary outcomes included limb status and major complications resulting in rehospitalization.
The hypothesis of the study was that after controlling for the severity of the limb injury, the presence and severity of other injuries and patient characteristics, patients undergoing amputation would have a better outcome than those undergoing reconstruction.
Patients undergoing early amputation were expected to achieve their maximum level of physical capacity and return to their usual major activities significantly sooner than patients undergoing limb reconstruction. Early amputation patients were also expected to have better psychosocial outcomes and quality of life than limb reconstruction patients.
What the authors found was that, in making a clinical treatment decision for a patient with limb-threatening lower extremity trauma, there is no right answer. Patients who had limb reconstruction achieved outcomes that were neither significantly worse nor better than those who had the limb amputated.
The analysis of the 545 patients enrolled in the project identified personality and patient characteristics that differ from U.S. norms and may bear on the exposure to events that resulted in severe injury. The patients were mostly male (77 percent) and younger than 45 years of age (71 percent). Only 70 percent were high school graduates, compared to the U.S. norm of 86 percent. Twenty-five percent of the patients lived in households with an income below the federal poverty line, compared to 16 percent of the national population. Thirty-eight percent had no health insurance, compared to the 20 percent national average, and the percentage of heavy drinkers was more than two times higher than that reported for the United States.
The next phase
Work on this research effort continues. "We have just completed the data collection on the next phase of the project, an outcomes assessment at 5 to 7 years from injury," said Dr. Bosse. "In this project, we are trying to determine if the results obtained at 2 years are stable or if they improve or worsen with time and adaptation to the injury. We are in the process of evaluating that data now." The next step, he added, is to translate the information gained to clinical practice.
"We are in the early stages of the development of a prospective randomized clinical trial treatment program," he said, "that will probably target reduction in complications and re-hospitalizations, identification and treatment of psychological stress disorders, early vocational rehabilitation and return to work strategies, and self-management skills as the interventions.
"Our long term goals," he continued, "are to develop strategies that will speed the recovery, limit the disability and return the patient to the work force."
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