A Registry of Upper-Spine Surgical Outcomes to Guide Patient Decisions Panel of neurosurgeons will compare procedures to treat CSM, a common problem in aging spines By: Laura Landro A research team led by a prominent neurosurgeon is creating a registry of outcomes for upper spine surgery, which future patients and doctors would be able to use to determine which surgical treatment is most beneficial, safest and cost-effective. The work is part of a study aimed at helping doctors and patients make better decisions about treating spinal cord compression, the most common spinal cord problem in Americans over 55. More aging baby boomers are experiencing neck stiffness, arm pain, numbness and weakness in the hands and legs—all signs of degenerative changes in the upper spine that are usually the result of everyday wear and tear. Strenuous activity or sports can exacerbate the damage. The changes over time can lead to a narrowing of the spinal canal and put pressure on the spinal cord. Coupled with repetitive motion, the compression can injure the cord, which in turn can inhibit movement of the hands and impair walking, and may even lead to paralysis. Currently, there are three different surgical techniques to fix spinal cord compression, known medically as cervical spondolytic myelopathy, or CSM. Researchers are trying to resolve ongoing uncertainty about which procedure leads to the best outcomes. In spine care, we are faced with a lot of people suffering and desperate for treatment, but there is a lack of information about what the best option is based on their specific symptoms and diagnosis, says Zoher Ghogawala, a neurosurgeon and co-director of the Comparative Research Effectiveness Institute at Lahey Healths Lahey Hospital and Medical Center in Burlington, Mass., a teaching hospital of Tufts University. Patients often end up with whichever procedure their doctor is most skilled at, Dr. Ghogawala says, rather than the one that may be best for their particular situation and anatomy. Though precise figures are hard to come by, Dr. Ghogawala estimates the number of CSM surgeries has nearly doubled over the past decade or so to 200,000 a year, with some $4 billion a year in hospital charges alone. Past studies indicate that two thirds of CSM patients improve with surgery, while in 15% to 30% of cases surgery isnt successful. Complication rates can be as high as 17%. Dr. Ghogawala is leading a three-year study at 10 large U.S. medical centers to compare the three surgical techniques and create the national spine outcomes registry to help patients and doctors determine which treatment is best for an individuals condition and situation. One sponsor is the Patient-Centered Outcomes Research Institute, authorized by Congress in 2011 to conduct research leading to better-informed treatment decisions. The investigators also received funding from the National Institutes of Health and a private foundation. Spinal cord compression can be caused by the bones, disks and ligaments of the spine. In addition, abnormal growths, or spurs, on the bones may be adding pressure. Some changes are the result of aging, and some are caused by arthritis of the neck. Once the spinal cord becomes severely compressed, surgery is considered necessary, although physical therapy and other nonsurgical management can help in less-severe cases. A large study published last year in the Journal of Bone and Joint Surgery found that patients with mild, moderate and severe CSM showed significant recovery after undergoing surgery. In one approach, known as front or ventral decompression and fusion, a surgeon cuts through the front of the neck, moves aside the voice box and esophagus to reach the spine, removes disks and bone spurs, and then fuses the vertebrae together. The average cost is $19,245 according to an earlier pilot study led by Dr. Ghogawala. In the other two techniques, a surgeon enters through the back of the neck and either fuses the vertebrae or performs a laminoplasty, a procedure to widen the spinal canal and relieve pressure on the spinal cord and nerves. The average cost with fusion is about $29,465, and Dr. Ghogawala says laminoplasty is the least costly, at about $12,000. The costs are typically covered by both Medicare and private insurance. There havent been randomized studies to compare the merits of the three techniques, though previous small, retrospective studies have demonstrated favorable results for fusion through the front and laminoplasty through the back. Steven Oliveira, 57, dean for development and alumni relations at Harvard Law School, was a marathon runner and tennis player when, in June 2012, he first began to feel numbness and clumsiness in his hands and pain across his shoulders and up his back. An MRI of his neck showed his vertebrae, disks and bone spurs were pressing heavily on his spinal cord. Mr. Oliveira says he was warned by a neurologist to address the condition immediately. He consulted with several neurosurgeons in the Boston area. They were all very convincing about the best way—but every single one of them was dramatically different, Mr. Oliveira says. Here you are as a patient trying to figure out whats best for you, but how do you sort this out? That is what the new study aims to do. Eligible patients between the ages of 45 and 75 will meet with surgeons who will explain the three possible options and the uncertainty among experts about which is best. The patients MRIs and X-rays will be reviewed by a panel of 15 experts—10 from participating centers and five from other hospitals—all of whom perform all three procedures. If an overwhelming majority of the experts chooses one strategy, patients will be advised to have that procedure. If there is a difference of opinion, the patient and doctor will discuss the reasons for the uncertainty and the patient will be randomly assigned to a treatment, unless the patient expresses a clear preference for one or another. Its as if patients had the ability to go to all the top surgeons in the country and get an opinion, says K. Daniel Riew, a professor of both orthopedic and neurological surgery at Washington University School of Medicine in St. Louis and an investigator for the CSM study. The aim is to identify whether a back operation with or without fusion is better, and which approach is best overall. We may also be able to identify some characteristics that make a given patient better suited to a particular operation, Dr. Riew says, such as a smoker or a diabetic, who may do better with a nonfusion procedure since they have problems with healing fused bones. Lifestyle considerations could prove to be important, Dr. Riew says. A singer or public speaker might be more likely to avoid front surgery, which can cause hoarseness or trouble swallowing. A laborer or athlete might avoid back surgery because of the possibility of postoperative neck pain and damage to nerves in the shoulder. Mr. Oliveira says he was fortunate that the last opinion he sought was with Dr. Ghogawala, who shared data from the 2011 pilot study he conducted in preparation for the larger trial and helped Mr. Oliveira understand pros and cons of the procedures. Dr. Ghogawala presented Mr. Oliveiras case to the 15 experts on the study panel, and the majority concluded he should have surgery through the front of the neck. Mr. Oliveira described his initial reaction: It scared the heck out of me and I would never in a million years do it. But he saw the evidence was convincing that he would have a quicker recovery and avoid the risk of shoulder complications that could prevent him from playing tennis. Dr. Ghogawala performed the surgery in August 2012, Mr. Oliveira says. He had no complications and was back in the office in three weeks. Advised against resuming distance running, Mr. Oliveira runs 4 to 5 miles, works out on an elliptical machine and plays tennis for up to five hours a day on weekends.
Posted on: Wed, 09 Apr 2014 13:13:27 +0000
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