The Truth about the Spine Patient Outcome Research Trial (SPORT) Study

The goal of the Spine Patient Outcome Research Trial (SPORT) study is to provide scientific evidence on the effectiveness of spinal surgery therapies versus a variety of non-operative treatments.

Conducted in 11 cities throughout the United States, the SPORT study has completed enrollment of nearly 3,000 patients. More than 1,000 patients were enrolled in the randomized portion of the clinical trial. A randomized study is where participants are assigned to a treatment group randomly, or by chance. An estimated 1,700 patients participated in what's called an observational group. In the SPORT study, patients were evaluated for two years.

The five-year, $13.5 million government-funded clinical trial will analyze the treatment of three types of spinal patients:

• Lumbar herniated disc (bulging or ruptured disc)
• Spinal stenosis (narrowing of the spinal canal)
• Degenerative spondylolisthesis (vertebra slips forward)

Surgical Treatment
All patients who were randomly selected to have surgery were required to undergo a series of non-operative treatment. When the non-operative treatment failed, these patients were treated with specific, standardized spinal surgery.

• The herniated disc patients had a decompression of the spinal nerve root through a standard open or microdiscectomy.
• The stenosis patients had a posterior (from the back) decompressive laminectomy.
• And the degenerative spondylolisthesis patients had a posterior decompressive laminectomy with or without a single-level, traditional spinal fusion. A traditional spinal fusion involves a bone graft taken from the patient's own hip for implantation to the spine.

Non-operative Treatment
Ranging from shoe inserts to epidural injections, the non-operative group of patients was prescribed a variety of treatments. Some of the treatments used were physical therapy, exercise, medications, chiropractic treatment and acupuncture. Other conservative treatments were added as the surgeon and the patient felt appropriate.

Flaws in the SPORT Study
Even though the SPORT study is a scientific clinical trial, it does have some flaws that may impact the validity of the results. Click on a SPORT study flaw below to learn more.

Patients who could clearly benefit from spinal surgery were immediately excluded from the SPORT study. It would have been unethical to deny these patients the care they needed, so only questionable candidates for surgery were enrolled in the study. Some experts feel that eliminating the group of patients who truly needed surgery may bias the results in favor of non-operative treatment. The patients in the SPORT study were all enrolled before July 2002 – the year that two of the most significant innovations in modern spinal surgery received U.S. Food and Drug Administration (FDA) approval. That year saw the introduction of Minimal Access Spinal Technologies (MAST™) Procedures that can reduce a patient's hospital stay, recovery time and scarring when compared with the traditional, open approach. And the introduction of INFUSE® Bone Graft, a bone growth protein, that eliminates the need for a second surgery to harvest bone from a patient's own hip (autograft) for transplantation to the spine, as is done in traditional spinal fusion procedures. The SPORT study is a review of yesterday's therapies and results.  Today's patients are more concerned about modern spinal procedures. The non-operative treatment options in the SPORT study are vague and unspecific. Surgeons can choose from 42 treatment options and more than 50 possible medications. Such open-ended guidelines, both with respect to duration as well as types of treatment, represent a serious flaw in the SPORT study's design and could really bias the outcomes in favor of non-operative treatment. The analysis of the SPORT study may also bias the results in favor of non-operative treatment. Any patient who was randomly assigned to the non-operative treatment group, but then switched to the surgical group will be recorded as a non-operative patient even though they received surgery. So, if non-operative treatment did not work for a patient, and he decided to have surgery and then felt better, his positive outcome would count favorably toward the non-operative results of the study. This is called an "intent-to-treat" analysis. Some experts disagree with this type of analysis and would like to see the SPORT study analyzed in a different way.

What Does This Mean For Patients?
Back surgery is not for everyone. But when other treatments fail, modern spinal surgery can be an important therapy option.

What you should be worried about is that the government-funded SPORT study may jeopardize your access to state-of-the-art surgical technologies that, if you need them, can help treat your condition or relieve your pain. The American Association of Neurological Surgeons (AANS) stated, "Public agencies and third party payers may interpret results of the SPORT study in such a way that there will be an unfair impact on the surgical options…with the result that many patients may be denied the more appropriate and effective treatment."

Each patient's condition is unique.  Regardless of what the SPORT study says, patients should continue to work closely with their doctor to determine their individual therapy plan.

Sources:

Design of the Spine Patient Outcomes Research Trial (SPORT): http://www.capconcorp.com/oba05/bios/designofSPORTtrial.pdf

American Association of Neurological Surgeons (AANS) Newsletter:
http://www.aans.org/library/Article.aspx?ArticleId=9860

• Published: February 23, 2006
• Updated: March 27, 2008