Surgeon is testing flexible neck repair

An orthopedic surgeon at St. Mark's Hospital is testing whether an investigational medical device can replicate a healthy cervical disk in people with herniations or ruptures in their necks.

Dr. Kade T. Huntsman is currently the only Utah surgeon participating in the 20-center clinical trial of NeoDisc, a polyester-woven bag with a silicon insert designed to preserve flexibility. The gold-standard treatment — a cervical fusion — uses bone, which makes the fused section of spine rigid rather than moveable.

There are a number of questions that the clinical trial is designed to answer, including whether the NuVasive Inc. device could be used earlier in the treatment process, whether it would better preserve neck range of motion and whether it lessens wear on adjacent vertebrae following surgery. It's very common for the vertebrae next to a fusion to degenerate over time.

The silicon insert is solid like rubber, not liquid, so it can't leak, Huntsman said. And it's designed to be a permanent implant, just like the section of bone now used in anterior cervical diskectomy and fusion, as the gold-standard procedure is called.

Since November, Huntsman has implanted six of the NeoDiscs and hopes to implant about 20 total during the two-year clinical trial. Nationwide, 480 will be implanted, including two at each site that are not part of the overall study data but are "training" procedures.

The study's not for everyone. Only patients with a single-level herniation or rupture are candidates. Those individuals must have typical symptoms such as pain, numbness and weakness because of the cervical problem. They must also have failed to get significant relief from six weeks of non-aggressive treatment, which includes anti-inflammatory medications, physical therapy and other measures.

Women who are pregnant or plan to be in the short-term cannot participate, and certain medical conditions such as diabetes and rheumatoid arthritis also make a patient ineligible. The individual also cannot have already had a cervical fusion at the same level on the spine. There are other exclusions, as well, including a history of substance abuse or the use of certain medications that could interfere with bone metabolism or healing.

Patients who qualify will be randomly assigned to receive a standard procedure or the investigational NeoDisc. Even Huntsman won't know which until the operation begins. Implanting the NeoDisc is no more complicated than a routine cervical fusion, he said.

A patient's range of motion is measured before and after surgery, as well as at intervals as healing progresses. That data will be analyzed by a company in Texas that does nonbiased measurement and analysis.

Those who end up with the investigational device — and their insurance companies — will never see a bill for the procedure, which will be paid for by NuVasive.

With the device or the standard surgery, patients are hospitalized overnight and followed for some time.

Results of the study are about two years away, Huntsman said.

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E-mail: lois@desnews.com