Healthcare Industry News:  discectomy 

Devices Orthopaedic Neurosurgery

 News Release - November 21, 2006

Medtronic Applauds Sport Study Confirmation of Positive Outcomes for Spinal Surgery Patients

World's Largest Device Manufacturer Encouraged by Research Suggesting Surgical Patients May Fare Better than Those Participating in Non-Operative Care

MINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE:MDT ) congratulates the efforts of the SPORT (Spine Patients Outcome Research Trial) Study, which was published today in the Journal of American Medical Association (JAMA). Two papers in the journal highlighted data from the discectomy trials and both reported positive clinical results for spine surgery patients.

While the $13.5 million, NIH-funded research conducted by Dr. James Weinstein and colleagues is widely considered by experts to be focused primarily on leg pain, the published data from the trials suggest significant improvement in patients receiving spinal surgery to treat disc herniation. Using a standardized disability measurement scale (Oswestry Disability Index or ODI), researchers cited a dramatic improvement, reaching an average of 31.4 points of improvement among surgery patients at a two-year follow-up.

"An improvement of this magnitude will essentially return a disabled patient to a more normal life," said Dr. Hallett Mathews, orthopedic spine surgeon at the Mid-Atlantic Spine Specialists in Richmond, Va. "These results are especially encouraging given the innate challenges of the study design and the high crossover rate reported in the study results."

In addition to the 31.4-point improvement in ODI scores, the JAMA papers highlighted several positive results, including:

  • At two years, the 31.4-point improvement of ODI scores, representing an impressive 66 percent improvement from pre-operative scores, was achieved among the randomized surgical patient cohort using the intent-to-treat method.
  • An even better 37.4-point increase was achieved by the surgical patients within the observational cohort. In fact, they performed significantly better (15 points) than the non-operative group, which is clinically meaningful.
  • 86.4 percent of the patients treated with surgery were pleased with their decision after two years.
  • Nearly three-quarters (74.2 percent) of those receiving surgery returned to full- or part-time work at two years.

Because of several issues with the design and execution of the study, the practicing surgical community has drawn cautious observations from the SPORT trial. For example, according to the papers in JAMA, the researchers reviewed the outcomes of the randomized clinical trial in two different ways:

"Intent-to-Treat" method: in essence, the researchers grouped and analyzed the patients by their original treatment assignments (surgical or non-operative) regardless of the treatment the patient ultimately received. A high percentage of patients (45 percent after two years) who were randomized to the non-operative group ended up crossing over to receive the operative treatment when the non-operative treatments failed their condition. In addition, a high percentage of patients (40 percent after two years) who were randomized to surgery had less severe symptoms and many ended up not having surgery. According to the conclusions of the paper published in JAMA, the researchers conceded "the intent-to-treat analysis in this trial showed no statistically significant treatment effects for the primary outcomes. However, the secondary measures of sciatica severity and self-reported progress did show statistically significant advantages for surgery." The researchers ultimately concluded "because of the high numbers of patients who crossed over in both directions, conclusions about the superiority or equivalence of the treatments are not warranted based on the intent-to-treat analysis alone."

Researchers also analyzed data with an "as treated" method since the crossover rates were much higher than the study protocol anticipated.

"As treated" method: researchers reviewed the outcomes or improvements of the actual surgical or non-operative treatment which the patient received. In this analysis, the patients treated with surgery showed a more clinically meaningful change than those who received non-operative treatment, including disability and pain outcomes.

"When evaluating outcomes strictly on the treatment the patient received, the results were very impressive," Mathews said. "And these results are not particularly surprising to the spinal community, as we all understand that discectomy is a great option for patients with this particular condition."

Mathews reminds patients that when all other treatments fail, modern spinal surgery can be a good option for patients living with back and leg pain. The positive conclusions drawn from the SPORT study promise to encourage dialogue among the surgical community concerning the continued advancements of modern spinal surgery.

"We surgeons thrive on learning from our peers and discussing the best treatments to give our patients," Mathews said. "I am very excited to participate in the upcoming conversations regarding the SPORT study."

Information on the SPORT Study, herniated disc patient stories and spinal surgery options can be found at www.back.com and www.insidespine.com.

About the Spinal Business at Medtronic

The Spinal business at Medtronic, based in Memphis, Tenn., is the global leader in today's spine market and is committed to advancing the treatment of spinal conditions. The Spinal business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for neurological, orthopedic and spinal conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies. More information about the company and its spinal treatments can be found at www.medtronicspinal.com and its patient-education Web sites, www.back.com, www.iscoliosis.com, www.maturespine.com and www.necksurgery.com.

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results.


Source: Medtronic

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