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

NCT00405691 | Completed Phase 3 DMC

• 1 other identifier: TOPS-US-IDE-002
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Low Back Pain; Leg Pain; Spondylolisthesis; Lumbar Spinal Stenosis

Keywords

Medical Device; Spine; Lumbar Spinal Stenosis; Degenerative Spondylolisthesis; Facet Arthrosis; Back and Leg Pain; Spine Research; Medical Device Research; Impliant; Lumbar Treatment; Spinal Treatment; Spinal Device

Outcome Measures

Primary Outcomes (6)

• Primary safety and effectiveness to determine patient success are: 1 .15% ODI improvement vs baseline at 24 mos; 20 mm leg and back pain VAS improvement vs baseline at 24 mos.

• 2. improvement of at least 20 mm in leg pain at 24 months compared to baseline using a VAS pain scale;

• 3. maintenance or improvement of neurological status;

• 4. no revisions, supplemental fixation, and removals;

• 5. absence of major device-related complications (device component degradation or breakage, device component separation or disassembly, device component loosening (including screw loosening)) requiring revisions, supplemental fixation, and removals;

• 6. absence of spontaneous fusion in the investigational group and lack of fusion in the control

Secondary Outcomes (4)

• Secondary outcome measurements that will be assessed include: 1. Zurich Claudication Questionaire scores, SF-36 scores, and VAS back pain score

• 2. Adverse events

• 3. time to recovery, work status, OR time, blood loss, and pharmaceutical use

• 4. radiographic measurements (degree of stenosis & spondylolisthesis, disc height, disc angle, alignment, translational motions, Range of Motion (affected level and entire lumbar spine), disc health (affected & adjacent levels), fusion status.

Interventions

"TOPS System" - Total Posterior Arthroplasty Implant DEVICE

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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
• 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.

Sponsors & Collaborators

• Impliant, Ltd.: lead

Study Sites (16)

Institute for Advanced Spinal Research In California

Beverly Hills, California, 90211, United States

Location

Century City Doctors Hospital

Beverly Hills, California, 90212, United States

Location

Seton Medical Center

Daly City, California, 94015, United States

Location

Yale University - School of Medicine

New Haven, Connecticut, 06519, United States

Location

The Orthopaedic & Sports Medicine Ctr.

Trumbull, Connecticut, 06611, United States

Location

Florida Orthopaedic Institute

Tampa, Florida, 33637, United States

Location

Illinois Neuro Spine Center

Ogden, Illinois, 60504, United States

Location

Saint Joseph Medical Center & Orthopaedic Associates

Baltimore, Maryland, 21204, United States

Location

The Boston Spine Group

Boston, Massachusetts, 02120, United States

Location

New England Neuro Assoc.

Springfiled, Massachusetts, 01104, United States

Location

Columbia Orthopedic Group

Columbia, Missouri, 65201, United States

Location

Orthopedic Spine Care of Long Island

Huntington Station, New York, 11746, United States

Location

Buffalo Spine Surgery

Lockport, New York, 14094, United States

Location

Carolinas Medical Center Hospital - Neurosurgery & Spine Associates

Charlotte, North Carolina, 28204, United States

Location

NeuroSpine Center of Wisconsin

Appleton, Wisconsin, 54913, United States

Location

Milwaukee Spinal Specialists

Milwaukee, Wisconsin, 53211, United States

Location

MeSH Terms

Conditions

Low Back Pain; Spondylolisthesis; Spinal Stenosis

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Paul McAfee, M.D.

  Orthopaedic Associates, P.A

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 29, 2006
• First Posted: November 30, 2006
• Study Start: September 1, 2006
• Last Updated: May 18, 2011

Record last verified: 2010-01

Locations

US (16)