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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 -- Medtronic, Inc. (NYSE NYSE

See: New York Stock Exchange
:MDT MDT
abbr.
Mountain Daylight Time


MDT (in the US and Canada) Mountain Daylight Time

MDT n abbr (US) (= mountain daylight time) →
) congratulates the efforts of the SPORT (Spine Patients Outcome Research Trial) Study, which was published today in the Journal of American Medical Association American Medical Association (AMA), professional physicians' organization (founded 1847). Its goals are to protect the interests of American physicians, advance public health, and support the growth of medical science.  (JAMA JAMA
abbr.
Journal of the American Medical Association
). Two papers in the journal highlighted data from the discectomy disc·ec·to·my
n.
The partial or complete excision of an intervertebral disk. Also called discotomy.
 trials and both reported positive clinical results for spine surgery patients.

While the $13.5 million, NIH-funded research conducted by Dr. James Weinstein James Weinstein, (July 17 1926 – June 16 2005) was an American historian and journalist best known as the founder and publisher of In These Times. Weinstein was a life-long socialist and early 20th-century American socialism was often the focus of his writings.  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 herniation /her·ni·a·tion/ (her?ne-a´shun) abnormal protrusion of an organ or other body structure through a defect or natural opening in a covering, membrane, muscle, or bone. . 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 Crossover rate

The return at which two alternative projects have the same net present value.
 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 Years, The

the seven decades of Eleanor Pargiter’s life. [Br. Lit.: Benét, 1109]

See : Time
 31.4-point improvement of ODI scores, representing an impressive 66 percent improvement from pre-operative scores, was achieved among the randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 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 according to
prep.
1. As stated or indicated by; on the authority of: according to historians.

2. In keeping with: according to instructions.

3.
 the papers in JAMA, the researchers reviewed the outcomes of the randomized clinical trial randomized clinical trial,
n a clinical study where volunteer participants with comparable characteristics are randomly assigned to different test groups to compare the efficacy of therapies.
 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 sciatica (sīăt`ĭkə), severe pain in the leg along the sciatic nerve and its branches. It may be caused by injury or pressure to the base of the nerve in the lower back, or by metabolic, toxic, or infectious disease.  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 Noun 1. herniated disc - a painful rupture of the fibrocartilage of the disc between spinal vertebrae; occurs most often in the lumbar region
ruptured intervertebral disc, slipped disc

rupture - state of being torn or burst open
 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 Minimally invasive surgical procedures avoid open invasive surgery in favor of closed or local surgery with less trauma. These procedures involve use of laparoscopic devices and remote-control manipulation of instruments with indirect observation of the surgical field through an  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 Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ended April 28, 2006. Actual results may differ materially from anticipated results.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Article Type:Clinical report
Date:Nov 21, 2006
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