Short and Long-Term Efficacy of Spinal Stabilisation System Investigated in Patients With Lower Back Pain
Tolochenaz, Switzerland (ots/PRNewswire)
A new study announced today by Medtronic will investigate the short and long-term benefits of adding a spinal stabilisation system to a standard herniectomy procedure in patients with spinal disc herniation. The study is the first randomised control trial to assess the clinical benefit and patient perception of the relief of lower back pain in patients with spinal disc herniation, comparing a standard herniectomy versus a herniectomy supplemented with the DIAM(TM) Spinal Stabilisation System.
"This new study is crucial to determine whether a spinal stabilisation system can help offer faster recovery time and reduce postoperative pain to patients with lower back pain undertaking a herniectomy and hence prevent or delay the need for spinal fusion," stated Dr. Ferdinand Krappel, an orthopaedic surgeon with Medizinisches Zentrum Kreis Hospital in Aachen, Germany, and a leading investigator of the DIAM study. "Compared to spinal fusion, this procedure is minimally invasive and it maintains the surgical site for future procedures if and when required."
It is estimated that more than 22 million people age 20 and older suffer from chronic back pain in Western Europe. One-third of these adults show evidence of herniated disc. Spinal disc herniation is also known as a slipped, ruptured or torn disc, and consists in a rupture of the spinal disc often occurring as a result of aging.
This multi-centre study expects to enroll 268 patients at 20 centres in six countries, including Belgium, Germany, Italy, Spain, Switzerland, and the United Kingdom. The study is the third of three planned randomised control trials investigating the benefits of the DIAM Spinal Stabilisation System in more than 1,000 patients in the United States and in Europe. The European trial endpoints include back pain relief at six months and reduction of disability at 12 months.
The herniectomy procedure takes approximately one hour and usually requires two to three days of hospitalisation. During the operation, the spinal stabilisation system is placed between the spinous processes (the visible ridges of the back) and is designed to act as a shock absorber that reduces loads on the surrounding vertebrae. The core of the DIAM System is made of silicone, while the outer mesh and tethers are made of medical-grade polyester. The flexible properties of the DIAM materials may also protect the integrity of the spinous process.
According to Lionel Hadjadjeba, vice president of the Spinal, Biologics and Navigation business at Medtronic, "Medtronic plays a leading role in the research on new device therapy for patients with chronic back pain, and learning more about the DIAM Spinal Stabilisation System will enable us to continue bringing therapies to market."
Back pain is one of the most common reasons for chronic disability and incapacity in the Western world.
About the Spinal Business at Medtronic
Medtronic's spinal business, 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.
Contact:
Contacts: Yvan Deurbroeck, Public Relations, +41-21-802-7574