D-H's SPORT Trial Honored for Innovative Orthopaedic Research
... patients who used non-surgical treatments such as physical therapy, yoga, medication, and acupuncture, reported almost equal results in pain, functionality, and satisfaction with their decision."
A landmark clinical trial that studies the effectiveness of the most common spine surgeries today received the ultimate honor in orthopaedics: the 2014 Orthopaedic Research and Education Foundation's (OREF) Clinical Research Award.
The award recipients were Dr. James N. Weinstein, Principal Investigator for the Spine Patient Outcomes Research Trial (SPORT), and the D-H physicians, researchers, patient coordinators, and analysts who have conducted the study.
"This is an incredible honor," said Weinstein, who is CEO and president of the Dartmouth-Hitchcock Health system and a spine surgeon. "In selecting SPORT, the Foundation has recognized the great work of my colleagues here at D-H and the 12 other participating centers across the country, as well as the contributions of the thousands of patients who agreed to be part of the trial."
SPORT, now in its 15th year, was funded by the National Institutes of Health to look for the first time at the efficacy of spine surgery over non-operative treatment for the most common causes of low back pain.
Low back pain is one of the most widely experienced health problems in the world. Eight out of 10 people will have back pain at some point in their lives. Next to the common cold, it is the main reason for missed work days and clinician visits. Costs of low back pain are estimated to exceed $100 billion per year in the United States.
Three of the most common conditions for which back surgery is performed are herniated disc; spinal stenosis; and spinal stenosis with a forward slippage of the bone, known as degenerative spondylolisthesis. Prior to SPORT, it was thought impossible to judge effectiveness of spine surgery using the traditional "gold standard" randomized clinical trial, where patients are blindly assigned to placebo or treatment.
SPORT used a unique study design, however, with both randomized and observational groups of patients, drawn from 13 multi-disciplinary spine centers across 11 states. In the first cohort, patients agreed to be assigned to surgery or non-operative treatment; in the second, patients chose their course of treatment themselves, but agreed to adhere to the strict study procedures and be followed over time. Importantly, the trial incorporated a shared decision making process, in which some 2,500 patient participants were given evidence-based information about the procedure being considered and its risks and benefits, so they could make an informed choice of their treatment.
Study results were reported at 2 years, 4 years and 8 years. They showed that surgery was clearly effective, particularly in patients with spinal stenosis or spondylolisthesis. In patients with herniated disc, while operative patients felt relief much more quickly and continued to be significantly better after surgery, at 2 years out, patients who used non-surgical treatments such as physical therapy, yoga, medication, and acupuncture, reported almost equal results in pain, functionality and satisfaction with their decision.
And, although the results for effectiveness of surgery for spinal stenosis were dramatically better than non-surgery, as of 8-year follow-up, 30 percent of patients who chose or were randomized to non-operative treatment continue to be satisfied with their choice and to continue without surgery.
"As a surgeon who thinks we do too much spine surgery, it was very important to me to know that these procedures, which happen thousands of times a day in this country, were safe and effective," said Weinstein. "We now know that the surgeries do make a significant positive difference for patients, but we also know that patients who choose not to have surgery do fine, and in some cases, just as well as those who have the surgery."
"The bottom line is that there are genuine options for patients contemplating surgery and the choice should be theirs," he said.
SPORT patients continue to be followed. As of this date, 54 papers based on the SPORT data have been published in peer-reviewed journals and more are in process. In addition to Dr. Weinstein, leaders of the Dartmouth-Hitchcock SPORT team include Dr. William A. Abdu, primary investigator for SPORT at the DHMC site, and Dr. Jon Lurie, a lead physician investigator. Drs. Sohail Mirza and Adam Pearson were also authors of the paper submitted to OREF for the award.
The award was announced at the 2014 Annual Meeting of the American Academy of Orthopaedic Surgeons in New Orleans on March 12. Dr. Weinstein has directed that the $20,000 prize award go to the Department of Orthopaedics Research Fund at Dartmouth-Hitchcock.
About the OREF Clinical Research Award
In 1994, the Board of Trustees of the Orthopaedic Research and Education Foundation (OREF) created the OREF Clinical Research Award to stimulate and recognize outstanding orthopaedic clinical research. These awards are considered the highest research award for orthopaedic surgeons and have been called the "Orthopaedic Nobel Prize". The Awards are chosen by the Research Development Committee of the American Academy of Orthopaedic Surgeons from manuscripts which represent a large body of cohesive and highly significant scientific work which reflects years of investigation in orthopaedic surgery. Previous winners of this award read like a "Who's Who" of high impact orthopaedic clinicians and researchers for whom clinical studies have resulted in numerous scientific breakthroughs and for which significant numbers of patients have benefitted from their research work. These awards are felt to represent researchers who have made most of the leading orthopaedic advancements of the past 60 years.