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xx TOPS™ Total Posterior Arthroplasty Clinical Study
« Thread started on: May 24th, 2007, 9:29pm »

TOPS™ Total Posterior Arthroplasty Clinical Study for Lumbar Spinal Stenosis
(Sponsored clinical trial listing)

http://www.spine-health.com/research/trials/tops/tops01.html


A randomized, multi-center clinical study of the TOPS™ Total Posterior Arthroplasty System for the treatment of leg pain associated with moderate to severe spinal stenosis of the lumbar spine.


Click for larger view
Introduction
It is estimated that 400,000 Americans suffer from leg and/or back pain associated with Lumbar Spinal Stenosis (LSS). Spinal stenosis is the narrowing of the spinal canal by bony elements, disc and/or ligaments which compress (pinch) nerves traveling through the spine into the legs (see illustration at right). Symptoms often include pain, weakness and numbness in the legs, calves and buttocks. For the majority of patients, symptoms decrease overtime with conservative treatment such as anti-inflammatory medication, analgesics, epidural injections, physical therapy and exercise. Unfortunately, there are individuals who do not improve after an extended period of time and may be a viable candidate for surgery.

To date, spinal decompression and fusion have been the standard surgical treatment for spinal stenosis. This is a technique in which a surgeon removes bone, disc, and/ or ligaments from the compressed nerves and stabilizes the treated level using metal implants such as titanium rods and screws. Bone graft is placed in the area to build a bony bridge between vertebral segments thus fusing and stabilizing the segment. Although spinal fusion has been an effective treatment for spinal stenosis, there has been recent discussion among spine experts that there may be benefits of maintaining and/or restoring motion at the treated level rather than eliminating it. Central to this discussion is the theory that maintaining motion better replicates the function of the healthy spine.

As a result, Impliant, Ltd., the sponsor of this study, has developed the TOPS™ Total Posterior Arthroplasty System to alleviate the symptoms of spinal stenosis by stabilizing but not fusing the affected vertebral level (see animation at right).

TOPS™ Total Posterior Arthroplasty System

Introducing the TOPS™ System
Click to view video



How the TOPS™ System Works
Click to view video
The TOPS™ System is comprised of two articulating titanium components interconnected with a polycarbonate urethane (PcU) sleeve. The device allows for motion between the two titanium components when the patient bends, twists or arches the back during everyday activities. Internal stoppers within the device help to prevent excessive motion. Additionally, the TOPS™ System is designed to dissipate forces at the treated vertebral segment instead of transferring abnormal loads to adjacent segments. (see animation at right).
Implantation of the TOPS™ System uses the same technique as fusion surgery through a traditional approach from the back. However, after decompression, the device is attached to standard pedicle screws instead of rigid titanium rods.

The TOPS™ System has already been studied extensively outside the United States in twenty-nine (29) patients. This study population has reported significant reduction in pain and disability compared to levels prior to surgery. Additionally, there were no device malfunctions or migrations and no device-related adverse events reported during the study. Based in large part on these findings, the Food and Drug Administration (FDA) has granted approval for Impliant to study the device in the United States.


TOPS™ Study objectives
The purpose of this study is to determine if the TOPS™ System is a safe and effective treatment for moderate to severe lumbar spinal stenosis.


TOPS™ Study overview
The TOPS™ clinical trial will enroll 300-450 patients and will be conducted at approximately twenty-five prestigious spine centers across the United States. This study will compare the treatment of severe to moderate spinal stenosis at L3-L4 or L4-L5 between two randomized study groups: (1) treatment with the TOPS™ System and (2) treatment with the current standard of care, posterior fusion. During surgery, all patients will undergo conventional neural decompression followed by either implantation of the TOPS™ System or posterior fusion with titanium screws and rods. The clinical status of each patient will be evaluated by the treating physician periodically over a 24-month to 36 month period.

Physicians conducting the TOPS™ study will be able to thoroughly discuss the benefits and risks associated with being a study participant.


TOPS™ Study sponsor
Impliant, Ltd. is a developer of spine motion-sparing alternatives to fusion surgery.


TOPS™ Study Status
Patients are currently being recruited to participate in this pivotal study.

If you are an individual, age 40 to 75 years old, suffering from pain, numbness, weakness, or cramping in the legs and thighs; and/or pain that radiates down the leg(s); and/or decreased sensation in the feet, you may qualify to participate in this study. Participating patients must have had at least six months of conservative (non-surgical) treatment without significant or lasting improvement.
TOPS™ Study Key inclusion criteria

Moderate to severe lumbar spinal stenosis at a single level between L3 and L5, with or without grade 1 degenerative spondylolisthesis, and with or without facet arthrosis

Leg pain

Age 40-75 years old (male or female)

Patient has undergone at least six (6) months of failed conservative treatment prior to surgery, including use of anti-inflammatory medications, administration of epidural/facet injections, physical therapy, and exercise

Patients that require minimal decompressive surgery at an adjacent level

Mentally and physically able to fully comply with the study follow-up schedule and requirements

TOPS™ Study Key exclusion criteria

Prior fusion surgery at any lumbar vertebral level

Clinically compromised vertebral bodies at the affected level(s) due to any traumatic pathology, including fractures

Known allergy to titanium and/or polyurethane

Scoliosis of greater than ten (10) degrees (both angular and rotational)

Obesity defined as a body mass index greater than 40 or more than 100 pounds over ideal body weight

AIDS, HIV, or active hepatitis

Patients with cancer (except non-melanoma skin cancer) in the past five (5) years

Pregnant or interested in becoming pregnant in the next three (3) years

Currently involved in another medical device investigational study

Pain that cannot be relieved in any spinal position

Patients with insulin-dependent diabetes mellitus

Note: there are additional inclusion/exclusion criteria. Physicians conducting the TOPS™ study will be able to determine if a patient meets all the necessary requirements to be a study participant.

TOPS™ Study Participating sites and contact information
Participating surgeons and spine centers have been carefully selected according to stringent criteria. All surgeons involved with the study are board-certified, fellowship-trained, and have extensive experience with spinal motion devices. Leading spine centers that are participating in the TOPS™ clinical study are located in:

Baltimore, MD
Boston, MA
Bridgeport, CT
New Haven, CT
Huntington, NY
New York, NY
Buffalo, NY
Utica, NY
Charlotte, NC
Ft. Lauderdale, FL
Appleton, WI
Chicago, IL
Columbia, MO
Dallas, TX
Los Angeles, CA
San Francisco, CA
Eugene, OR
Tacoma, WA

Additional sites will be added in the future.

Interested in participating?
If you are a patient or a family member of someone that meets the criteria outlined above and are interested in participating in the TOPS™ clinical study, please fill out our Contact Form. You will be contacted by phone and/or email regarding possible participation in this study. Thank you for your interest.

Caution: TOPS™ device is an Investigational Device and is limited to investigational use in the United States.

The information provided by Spine-Health in this Clinical Trials listing section is designed to help patients find clinical trials that are ongoing in the field of spine medicine, and to provide information to help patients contact the centers conducting the research. Spine-Health is not involved in conducting any of these trials and is not promoting the trials or research.

This is a listing of industry-sponsored clinical trials that are actively recruiting patients. These clinical trial listings are not edited or peer-reviewed by Spine-health.com.

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William Looney
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xx Re: TOPS™ Total Posterior Arthroplasty Clinical St
« Reply #1 on: Feb 1st, 2012, 10:46pm »

I have L4-5 spinal stenosis. I have had spacer and laminectomy procedures. I would be interested in participating in this study. My telephone # is 206-595-2506. I live in Tacoma WA. Thank you.
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