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Clinical trial at Backus testing new spinal surgery

A new surgery intended to relieve the pain associated with spinal stenosis was performed for the first time at Backus Hospital on Monday, Oct. 30. It is part of a national clinical trial involving a joint replacement device in the spine.

Backus Hospital is one of eight sites in the U.S. currently participating in the investigational study.
An estimated 400,000 Americans have spinal stenosis, a narrowing of spaces in the spine that results in pressure on the spinal cord and nerves and can lead to debilitating back pain or even paralysis if left untreated. The number of people affected by this condition is only expected to grow as more baby boomers reach their 50s and 60s.

Michael Halperin, MD, an orthopedic surgeon on the Backus Medical Staff who performed the first surgery, said the hospital is accepting patients who fit the criteria, but because it is a study, some patients will receive the traditional treatment, which includes fusing the joints, while others will receive the joint replacement. Two out of every three applicants will receive the investigational surgery.

The data from these surgeries will be sent to the U.S. Food and Drug Administration. A total of 450 clinical study surgeries will be performed throughout the nation and sent to the FDA to determine whether there is an equal or better outcome with the investigational surgery.

“The artificial joint allows the preservation of motion,” said Dr. Halperin, who performed the first surgery at Backus.

To be eligible for the clinical study, patients must be between the ages of 50-85. Patients with spinal stenosis can contact Dr. Halperin to see if they qualify for the study. Only patients who need decompression and stabilization of the spine will qualify. It will include follow-up after the surgery. He said there is a limit of 50 cases per surgeon. Kenneth Paonessa, MD, an orthopedic surgeon on the Backus Medical Staff, will also be involved in the study.

“We are very excited to be part of this cutting-edge spinal device trial,” said Paula Provost, Research Protocol Coordinator for the Clinical Research Department at Backus, which during the trial is working closely with the company that produces the device, Archus Orthopedics, the Norwich Orthopedic Group, the Institutional Review Board and other impacted Backus departments. “We are hopeful that patients will benefit from this experimental surgery as more information is collected about the device.”

Ms. Provost said the hospital’s Institutional Review Board has approved the study.
Dr. Halperin said the potential advantages of the joint replacement option are:

• The spine remains more mobile, because it is not fused.
• Often fusing can cause stress to the joints above and below the fusion and they can degenerate, so the facet joint replacement procedure may reduce the potential problem.
• During recovery from a fusion, activities are limited for six weeks to three months or longer, whereas with an artificial joint the patient may be able to return to normal activities sooner since they are not having their spine fused.
• Fusion surgery often requires a bone graft from the pelvis. Since this is not necessary for the facet joint replacement procedure, the surgery may result in less blood loss, fewer complications and reduced time in the operating room for the patient. Also, bone grafts can often cause chronic post-operative pain in the pelvic area.

When spinal stenosis is diagnosed, medications or steroid injections are often administered to reduce inflammation. If the pain does not respond and is persistent, surgery is considered to relieve pressure on the nerves. Sometimes, in spinal stenosis, the vertebrae shift or slip in relation to each other (spondylolisthesis). Abnormal motion (instability) may then occur between the vertebrae. In such cases, spinal fusion surgery may be required in addition to decompression in order to stabilize the involved vertebrae.

Dr. Halperin said the laminectomy and fusion operation has been the same basic operation since the 1950s. The investigational surgery would still include laminectomy, which is removal of the roof of the vertebrae to create more space for the nerves, but instead of fusion, an artificial joint would be used.