Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis

Completed · Phase 3

Conditions studied: Low Back Pain, Leg Pain, Spondylolisthesis, Lumbar Spinal Stenosis

In brief

The purpose of this multi-center, randomized, clinical study is to establish the safety and effectiveness of the TOPS™ System, used following decompression, in the treatment of lower back and leg pain with, or without spinal claudication, that results from moderate or severe lumbar spinal stenosis at one vertebral level between L3 and L5.

Key facts

Study ID

NCT00405691

Run by

Impliant, Ltd.

People needed

450

Starts

2006-09-01

Last updated by the study team

2011-05-18

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Moderate to Severe lumbar spinal stenosis at a single level* between L3 - L5, with radiographic confirmation of any one of the following on CT, MRI, plain x-ray or myelography:
• Evidence of thecal sac and/or cauda equina compression
• Evidence of nerve root impingement by either osseous or non-osseous elements;
• Evidence of hypertrophic facets with canal encroachment Moderate/severe spinal stenosis is further defined radiographically as;
• moderate canal stenosis is a 25-49% reduction in the A/P dimension of the central and/or lateral foramen when compared to adjacent (cephlad) level
• Severe canal stenosis is defined as 50% or greater reduction in the A/P dimension of the central and/or lateral foramen when compared to the adjacent (cephlad) level **Patients which require minimal decompressive surgery at an adjacent level, may have a laminonotmy or soft tissue resection as long as the decompression does not compromise the stability of the adjacent segment.
• At least six (6) months of failed, conservative treatment prior to surgery, including physical therapy, use of anti-inflammatory medications at maximum specified dosage; administration of epidural/facet injections.
• Age 40-75 years old (male or female).
• Up to one prior surgery without instrumentation implanted at any lumbar vertebral level limited to the following:
• IDET,
• laminotomy,
• laminectomy,
• foraminotomy
• Discectomy (that occurred at least three years ago without any reoccurrence of herniation)
• Lower back pain and/or sciatica with or without spinal claudication.
• VAS leg pain of at least 40/100 at baseline.
• Oswestry Questionnaire score of at least 40/100 at baseline.

You may not qualify if…

• Back or non-radicular leg pain of unknown etiology
• Spondylolisthesis Grade II or higher
• Stenosis caused by an extruded spinal disc fragment
• Lytic spondylolisthesis
• More than one (1) motion segment involved in the degenerative pathology to the extent that justifies its inclusion in the surgical procedure, unless a decompression alone can be done at that level without compromising stability.
• Known allergy to titanium and/or polyurethane
• Prior fusion surgery at any lumbar vertebral level with or without instrumentation
• Supplemental interbody support required (e.g., bone graft, spacers, VBRs, or fusion cages)
• Clinically compromised vertebral bodies at the affected level(s) due to any traumatic, neoplastic, metabolic or infectious pathology.
• Scoliosis of greater than ten (10) degrees (both angular and rotational)
• Morbid obesity defined as a body mass index > 40 or a weight more than 100 lbs. over ideal body weight.
• Note: Additional inclusion/exclusion criteria are applied. Please contact Impliant for further details.

Where it is running

• Institute for Advanced Spinal Research In California — Beverly Hills, California, United States
• Century City Doctors Hospital — Beverly Hills, California, United States
• Seton Medical Center — Daly City, California, United States
• Yale University - School of Medicine — New Haven, Connecticut, United States
• The Orthopaedic & Sports Medicine Ctr. — Trumbull, Connecticut, United States
• Florida Orthopaedic Institute — Tampa, Florida, United States
• Illinois Neuro Spine Center — Ogden, Illinois, United States
• Saint Joseph Medical Center & Orthopaedic Associates — Baltimore, Maryland, United States
• The Boston Spine Group — Boston, Massachusetts, United States
• New England Neuro Assoc. — Springfiled, Massachusetts, United States
• Columbia Orthopedic Group — Columbia, Missouri, United States
• Orthopedic Spine Care of Long Island — Huntington Station, New York, United States
• Buffalo Spine Surgery — Lockport, New York, United States
• Carolinas Medical Center Hospital - Neurosurgery & Spine Associates — Charlotte, North Carolina, United States
• NeuroSpine Center of Wisconsin — Appleton, Wisconsin, United States
• Milwaukee Spinal Specialists — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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