Durango's Dr. Jim Youssef is one of 16 surgeons nationally who are participating in clinical testing of a device that could make a common complaint of the elderly - "Oh, my aching back" - a lament of the past.
The device is an artificial facet joint, one of the overlapping bony, spread-eagle-shaped structures on the back of the lower spine that hold vertebrae in place and allow motion and flexibility. As the body ages, facet joints degenerate, creating bone spurs that can press against spinal nerves and cause low-back pain and debilitating lumbar spinal stenosis.
Annually, 83 million Americans see a doctor for back pain, said Youssef, a spine surgeon at Durango Orthopedic Associates/Spine Colorado.
Until now, the elderly had limited remedies other than becoming sedentary - use a cane or walker to support their weight, medication, surgery to trim or remove the facet joint, or fusion of vertebrae, which can bring complications. But the artificial facet joint, made of titanium and a cobalt-chromium alloy, can restore normal range of motion and decrease or eliminate pain.
"We're always looking for substitutes for fusion," said Youssef, who has performed a half-dozen facet-replacement surgeries. He was the first surgeon in Colorado to perform facet-joint replacement and is one of only two surgeons in the state participating in the clinical trial.
Clinical trials of medical devices are conducted in the United States only after they've proven safe and reliable, Youssef said. Trials outside the U.S. are followed by pilot studies in the U.S. and finally pivotal (clinical) trials. The facet-joint research he is participating in nationally ultimately will involve 400 patients, who will be followed for as many as four years after surgery, he said.
Youssef, 45, received a degree in genetics from the University of California at Berkeley and attended medical school at the University of California at Irvine. He was in Brazil a few weeks ago to participate in another pilot-level spine surgery. He also did pro-bono surgery there.
"I do research because it's technologically advantageous," Youssef said. "It's hard to gain access to new technology unless you participate in clinical studies."
Facet-joint surgery itself is simple, Youssef said. Patients are up and walking immediately after their operation, which lasts a little more than one hour, and they go home the next day. After four weeks of healing, patients perform six weeks of physical therapy to build core and muscle strength and increase aerobic capacity.
Candidates for an artificial facet joint must, among other requirements, be 21-85 years old, have a certain level of pain, have tried conventional treatment (but not fusion or disc replacement) and be willing and able to comply with postoperative routines.
Applicants are washed out for a variety of reasons, among them a host of physical ailments or diseases, being a drug user, being obese or having litigation pending regarding back pain or injury. Smokers need not apply, Youssef said.
"Smoking inhibits bone fusion, hinders scar formation and circulation and increases the chance for infection," Youssef said. "Spine surgery, like a marriage, involves expectations and obligations. If I give 100 percent, the patient has to give 100 percent."