search
Back to results

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

Primary Purpose

Low Back Pain, Leg Pain, Spondylolisthesis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
"TOPS System" - Total Posterior Arthroplasty Implant
Sponsored by
Impliant, Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring 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

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA:

  • 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.

EXCLUSION CRITERIA:

  • 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.

Sites / Locations

  • Institute for Advanced Spinal Research In California
  • Century City Doctors Hospital
  • Seton Medical Center
  • Yale University - School of Medicine
  • The Orthopaedic & Sports Medicine Ctr.
  • Florida Orthopaedic Institute
  • Illinois Neuro Spine Center
  • Saint Joseph Medical Center & Orthopaedic Associates
  • The Boston Spine Group
  • New England Neuro Assoc.
  • Columbia Orthopedic Group
  • Orthopedic Spine Care of Long Island
  • Buffalo Spine Surgery
  • Carolinas Medical Center Hospital - Neurosurgery & Spine Associates
  • NeuroSpine Center of Wisconsin
  • Milwaukee Spinal Specialists

Outcomes

Primary Outcome Measures

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 Outcome Measures

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.

Full Information

First Posted
November 29, 2006
Last Updated
May 17, 2011
Sponsor
Impliant, Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT00405691
Brief Title
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis
Official Title
A Prospective, Multi-Center Clinical Study to Assess the Saftey and Effectiveness of the Impliant TOPS System
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Impliant, Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
"TOPS System" - Total Posterior Arthroplasty Implant
Primary Outcome Measure Information:
Title
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.
Title
2. improvement of at least 20 mm in leg pain at 24 months compared to baseline using a VAS pain scale;
Title
3. maintenance or improvement of neurological status;
Title
4. no revisions, supplemental fixation, and removals;
Title
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;
Title
6. absence of spontaneous fusion in the investigational group and lack of fusion in the control
Secondary Outcome Measure Information:
Title
Secondary outcome measurements that will be assessed include: 1. Zurich Claudication Questionaire scores, SF-36 scores, and VAS back pain score
Title
2. Adverse events
Title
3. time to recovery, work status, OR time, blood loss, and pharmaceutical use
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul McAfee, M.D.
Organizational Affiliation
Orthopaedic Associates, P.A
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Advanced Spinal Research In California
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Century City Doctors Hospital
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
Seton Medical Center
City
Daly City
State/Province
California
ZIP/Postal Code
94015
Country
United States
Facility Name
Yale University - School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
The Orthopaedic & Sports Medicine Ctr.
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Florida Orthopaedic Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33637
Country
United States
Facility Name
Illinois Neuro Spine Center
City
Ogden
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Saint Joseph Medical Center & Orthopaedic Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
The Boston Spine Group
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States
Facility Name
New England Neuro Assoc.
City
Springfiled
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
Facility Name
Columbia Orthopedic Group
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Orthopedic Spine Care of Long Island
City
Huntington Station
State/Province
New York
ZIP/Postal Code
11746
Country
United States
Facility Name
Buffalo Spine Surgery
City
Lockport
State/Province
New York
ZIP/Postal Code
14094
Country
United States
Facility Name
Carolinas Medical Center Hospital - Neurosurgery & Spine Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
NeuroSpine Center of Wisconsin
City
Appleton
State/Province
Wisconsin
ZIP/Postal Code
54913
Country
United States
Facility Name
Milwaukee Spinal Specialists
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs