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Low Back PainPhase 3NCT00405691

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

A Phase 3 study testing "TOPS System" - Total Posterior Arthroplasty Implant in people with Low Back Pain and Leg Pain, run by Impliant, Ltd. at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Low Back Pain, Leg Pain, Spondylolisthesis
What is being tested?
"TOPS System" - Total Posterior Arthroplasty Implant
Type of treatment
Medical device
How many people
450 participants
Where
16 sitesUnited States
Study dates
Sep 2006to not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • NeuroSpine Center of Wisconsin

    Appleton, Wisconsin, 54913

  • Saint Joseph Medical Center & Orthopaedic Associates

    Baltimore, Maryland, 21204

  • Institute for Advanced Spinal Research In California

    Beverly Hills, California, 90211

  • Century City Doctors Hospital

    Beverly Hills, California, 90212

  • The Boston Spine Group

    Boston, Massachusetts, 02120

  • Carolinas Medical Center Hospital - Neurosurgery & Spine Associates

    Charlotte, North Carolina, 28204

  • Columbia Orthopedic Group

    Columbia, Missouri, 65201

  • Seton Medical Center

    Daly City, California, 94015

  • Orthopedic Spine Care of Long Island

    Huntington Station, New York, 11746

  • Buffalo Spine Surgery

    Lockport, New York, 14094

  • Milwaukee Spinal Specialists

    Milwaukee, Wisconsin, 53211

  • Yale University - School of Medicine

    New Haven, Connecticut, 06519

  • Illinois Neuro Spine Center

    Ogden, Illinois, 60504

  • New England Neuro Assoc.

    Springfiled, Massachusetts, 01104

  • Florida Orthopaedic Institute

    Tampa, Florida, 33637

  • The Orthopaedic & Sports Medicine Ctr.

    Trumbull, Connecticut, 06611

Other trials in United States

About this study

Official title: A Prospective, Multi-Center Clinical Study to Assess the Saftey and Effectiveness of the Impliant TOPS System

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.

Read the detailed description

This study is being conducted to evaluate a new surgical implant (TOPS™ System, Impliant). The TOPS™ System is an alternative to spinal fusion that is designed to stabilize but not fuse the affected vertebral level following decompression surgery to alleviate pain stemming from moderate/severe lumbar spinal stenosis while maintaining range of motion.

When non-surgical treatment is ineffective, decompression (including laminectomy and medial facetectomy) and fusion of the spinal segments with moderate/severe lumbar spinal stenosis has been used to stabilize the motion segment and to alleviate the patient's clinical symptoms. Spinal fusion surgery using metal instrumentation is designed to stop motion at a painful, unstable spinal segment by permanently fusing the segment. While fusion may decrease pain generated at the treated segment, the procedure also eliminate motion at the implanted level and transfers and thus increases loads on the adjacent segments.

The TOPS System is intended to provide stabilization following decompression in patients with disease at one level from L3 to L5. The ideal goal of stabilization is to preserve mobility but eliminate abnormal motion and prevent deformity. By using the TOPS System, it may be possible to preserve load-bearing dynamics and spinal biomechanics, and thereby maintaining motion at the treated segment.

The TOPS surgical technique, utilizing a standard top loading pedicle screw-based system, is the same as a standard posterior spinal fusion with the exception of the placement of the TOPS motion segment. Therefore, the surgeon will be executing the steps of surgical exposure, decompression, insertion of pedicle screws (with attention to proper placement/alignment) and closure in the same manner as he/she would in a standard posterior spinal fusion.

The objective of the clinical investigation is to compare the safety and effectiveness of the TOPS System to a control group of patients undergoing posterior spinal fusion with pedicle screws and local autograft bone in the treatment of back and leg pain that results from moderate/severe lumbar spinal stenosis at a single vertebral level between L3 to L5.

Prior to entering the study, patients will be evaluated by the investigator according to the inclusion/exclusion criteria. Patients recruited to the study will be randomized in a 1:1 ratio to undergo implantation of the TOPS System or the control spinal fusion procedure. Patient follow-up will be evaluated immediately post-operatively and at discharge, 6 weeks, 3 months, 6 months, 12 months, and 24 months.

Being tested
"TOPS System" - Total Posterior Arthroplasty Implant
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
Medical subject headings
Low Back Pain, Spondylolisthesis, Spinal Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "TOPS System" - Total Posterior Arthroplasty ImplantDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

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

  3. 3. maintenance or improvement of neurological status;

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

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

Secondary outcomes (4)

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

  2. 2. Adverse events

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

  4. 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2006 (estimated)
  2. Study startSep 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00405691
Sponsor's protocol ID
TOPS-US-IDE-002
Status last verified
Jan 2010
First submitted
29 Nov 2006
Last updated
18 May 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing "TOPS System" - Total Posterior Arthroplasty Implant in people with Low Back Pain and Leg Pain, run by Impliant, Ltd. at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00405691.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2011; AzTrials last refreshed its copy on 7 Nov 2026.

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