Surgery May Provide More Rapid Improvement for Spinal Stenosis
February 20, 2008
Individuals suffering from a common back condition known as spinal stenosis improve more with surgery than with non-surgical treatment, according to a multi-center, multistate trial led by Dartmouth clinician-researchers. However, the study also reveals that patients who choose not to have surgery are likely to improve over time.
The paper, published in the February 21st edition of the New England Journal of Medicine, is the third in a series of study results from the Spine Patient Outcomes Research Trial (SPORT.) The seven-year, $21 million trial is led by Dr. James N. Weinstein, Chair of the departments of Orthopaedics at Dartmouth-Hitchcock Medical Center and Dartmouth Medical School, and
Director of the Dartmouth Institute for Health Policy and Clinical Practice.
Dr. Weinstein, a practicing spine surgeon, said the spinal stenosis study will be significant for millions of patients and their doctors. “Spinal stenosis is the most common reason for lumbar spine surgery in patients over 65,” he said. “For the first time, we have an evidence base on which to advise our patients.”
The SPORT studies were launched in 2000 to look at the three most common back conditions leading to surgery: herniated disk with sciatica; spinal stenosis; and a variation of spinal stenosis where one vertebra has slipped forward over the other, a condition known as spondylolisthesis.
Although $24 billion is spent annually on back surgery, until SPORT there had not been a large scale randomized trial conducted to find out how effective operative procedures were when compared with non-surgical therapies for these three conditions.
In the first study results, for herniated disk with sciatica, although surgical patients did slightly better than non-surgical patients, both groups showed significant improvement at 1 and 2 years from entering the trial. In contrast, these most recent spinal stenosis studies show a marked advantage for those patients who had surgery. Surgical patients saw improvement more rapidly and reported better physical function and less pain than did the non-surgical patients, who reported only moderate improvement 2 years after their diagnosis.
But says Weinstein, it’s significant that almost none of the non-surgical patients got worse without an operation. And on average, they reported small improvements in all measures. “What we now know and can share with our patients is that they have a choice. If they choose surgery, they will improve greatly. But if their preference is not to have surgery, their condition
is not likely to worsen and they will see some improvement over time,” he said.
Spinal stenosis is a narrowing of the spinal canal that causes a progressive squeezing of the nerves, leading to pain in the buttocks or legs when walking or standing. It is most commonly seen in adults over 60. When surgery is performed, excess bone, ligament, and soft-tissue are removed to allow more room for the nerves, a procedure called a laminectomy. Lumbar spinal
fusion may, in rare cases, also be performed to prevent instability of the spine. Non-surgical treatments for spinal stenosis include physical therapy, exercise, chiropractic, epidural injections, and anti-inflammatory drugs.
Source: http://www.dartmouth.edu/sport-trial/
Higher Rate of Bone Formation thru Combination of Bone Marrow Removal and Anabolic Therapy?
February 12, 2008
Unigene Laboratories, Inc. reported that the results of animal studies confirming the ability of its novel technology to rapidly form and maintain natural bone growth at targeted locations has been published. The paper, entitled “Replacement of Bone Marrow by Bone in Rat Femurs: The Bone Bioreactor,” summarizes the early-stage collaborative work performed by researchers at Yale University School of Medicine and Unigene, and appears in the most recent edition of the journal Tissue Engineering.
The paper evaluated the effect of bone marrow removal from targeted sites followed by different schedules of daily injections of anabolic agents such as parathyroid hormone (PTH). The procedure created new bone tissue that appears structurally and biologically normal and demonstrated improved biomechanical properties. The combination of bone marrow removal and anabolic therapy resulted in new bone formation at a rate and to an extent that could not be achieved with anabolic agents alone. Additional studies that extend the results of this work in different animal models are ongoing. These studies should provide further evidence that the newly formed bone can be preserved over a long period of time, and will be described in future publications.
“This technology could radically change the way patients are currently treated for weakened or fractured hips, vertebrae and acute traumatic long bone fractures,” stated Dr. Agnès Vignery, principal investigator at Yale University and senior author of the publication. “Physicians currently treat such conditions using invasive techniques that require operating room time, utilize artificial materials, and result in imperfect outcomes. The ideal approach would be to create new bone where it is needed and at a faster rate.”
Dr. Warren Levy, President and CEO of Unigene said:
“If we are successful in the human studies that are planned, patients will have an inexpensive alternative to spinal fusion, vertebroplasty, total joint replacement or the insertion of metal or plastic supports that will strengthen specific bones naturally. These are major commercial opportunities and we have been told by leading experts in the medical community that there is a great need for new approaches to treat these conditions.”
SOURCE: Unigene Laboratories, Inc.
