Dr. Vaccaro, professor of orthopaedic surgery and neurological surgery at Jefferson Medical College of Thomas Jefferson University in Philadelphia and the Rothman Institute at Thomas Jefferson University Hospital and his colleagues are trying to answer a very difficult and controversial question:
Should surgeons operate immediately, within hours of the severe spinal injury, to try to limit the damage to the spinal cord and surrounding tissues, as many surgeons believe? Or won’t it make a difference in how a patient ultimately fares, as others, citing their experiences, say?
Dr. Vaccaro, in conjunction with Michael G. Fehlings, M.D., at Toronto Western Hospital, is spearheading a multicenter trial called STASCIS, which looks at timing of surgery, the timing of spinal reduction and a prospective evaluation of how patients do.
STASCIS is an acronym for the Surgical Treatment of Acute Spinal Cord Injury Study. Begun in 2003, STASCIS is both an observational and prospective randomized study aimed at determining if patients with spinal cord injury will benefit from early treatment to reduce pressure on the spinal cord.
Two types of injuries occur when the spinal cord is damaged, says Dr. Vaccaro, co-director of the Delaware Valley Regional Spinal Cord Injury Center at Jefferson. The primary injury is the actual physical insult to the spinal cord, including bruising, bleeding and any kind of disruption to the cord and its functioning. But a secondary injury also occurs, usually between the first day after the initial damage to as many as three to five days later. Cell and tissue death begins – including apoptosis, or programmed cell death – as electrolytes like calcium and sodium become out of balance.
This secondary cascade of spinal cord injury, he says, can be reduced. “There’s not much we can do about the initial injury that’s already occurred,” he says. “But how we handle the secondary injury may determine whether or not a person will walk again. If we intervene early, with appropriate medical treatment such as steroids, for example, or physically taking off the pressure from the spinal cord compression, which can cause further cell death, we can affect the secondary cascade of injury.”
According to Dr. Vaccaro, animal studies on spinal cord injuries show that the sooner pressure is removed from a compressed spinal cord, the better the recovery of function. “We believe that compression causes electrolyte changes, cell death and apoptosis,” he says. “From an experimental standpoint, the data is unequivocal: operate early. But we’ve never been able to translate that into the clinical setting.”
In the study, patients at Jefferson who have a cervical spinal cord injury may be randomized to an early or late treatment group, depending on when they actually undergo surgery. If the patient has a cervical dislocation, the surgeon attempts to correct the dislocation as soon as medically possible. Patients who arrive after the study’s window of treatment time are placed in an observational treatment group.
He notes that at other participating hospitals which tend to see fewer patients with spinal cord injuries, surgeons treat each patient however they think is best in terms of the timing of surgery to reduce the pressure on the spinal cord. Because of the lack of clear guidelines for such surgeries, some doctors assume that timing doesn’t really affect long-term results. Perhaps it’s better to simply stabilize the injured patient, attend to any additional injuries, allow the inflammatory reactions to run their courses and put a little more planning into the surgery.
But others, including Dr. Vaccaro, see the timing as critical. Immediate treatment to reduce the pressure on the spinal cord might keep the secondary injury to a minimum, potentially sparing additional neurological problems. And possibly even allow for some of the initial damage to be reversed.
“My intuitive belief is that operating earlier is better,” Dr. Vaccaro says. “I have many anecdotal cases where operating earlier resulted in improved results.” Results from the participating centers will be pooled. The goal is to enroll a minimum of 450 patients at 20 centers. The outcomes from the patients who were treated early, in the first 12 to 24 hours after injury, will be compared to those who had treatment more than 24 hours subsequent to the initial damage. To participate, individuals must be betweenthe ages of 16 and 70, and have had a traumatic cervical fracture or dislocation with the accompanying neurological complications. At present, the study continues to enroll participants and is about 25 percent complete.
Dr. Vaccaro expects that that study’s results will change the standard of care for severe spinal cord injuries. Next, he says, he plans to focus on the genetic and medical factors that might play roles in recovery.
For more information on this trial, please call 267-339-3612 or 1-800-JEFF-NOW.
Steve Benowitz | EurekAlert!
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