TOPS™ System Post Marketing Study To Evaluate The Safety And Effectiveness Of TOPS™ System

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Premia Spine
Sponsor:
Information provided by (Responsible Party):
Premia Spine
ClinicalTrials.gov Identifier:
NCT01933607
First received: March 8, 2013
Last updated: September 1, 2013
Last verified: September 2013
  Purpose

This Single-Arm Post-Marketing Evaluation will gauge the improvement in function and pain for lumbar spinal stenosis and spondylolisthesis patients with the TOPS System.


Condition Intervention
Spinal Stenosis
Spondylolisthesis
Device: TOPS System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study To Evaluate The Safety And Effectiveness Of TOPS™ System In The Lumbar Spine

Resource links provided by NLM:


Further study details as provided by Premia Spine:

Primary Outcome Measures:
  • VAS (Visual Analog Score) [ Time Frame: 2 YEARS ] [ Designated as safety issue: No ]
    Pain assessment


Secondary Outcome Measures:
  • SF-36 (Short-Form) [ Time Frame: 2 YEARS ] [ Designated as safety issue: No ]
    Quality of life


Estimated Enrollment: 10
Study Start Date: October 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TOPS System
TOPS™ System Post Marketing Study
Device: TOPS System
TOPS™ System Post Marketing Study To Evaluate The Safety And Effectiveness Of TOPS™ in the Lumbar Spine

Detailed Description:

This Single-Arm Post-Marketing Evaluation will gauge the improvement in function and pain for lumbar spinal stenosis and spondylolisthesis patients with the TOPS System. Patients who are scheduled to undergo spinal surgery as part of their medical treatment and comply with the study inclusion/exclusion criteria will be recruited. Patients will undergo standard surgical decompression prior to device implantation. For patients with two or three levels of disease, the TOPS System will be combined with the Versalink Fixation System. All study devices are CE marked.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Any subject meeting the following criteria will be considered for inclusion in this trial.

  1. Patients with one or both of the following conditions at a single spinal level between L3 and L5 are eligible for the TOPS™ System:

    • Symptomatic monosegmental lumbar spinal stenosis or facet arthrosis
    • Degenerative Spondylolisthesis up to and including grade 1
  2. At least three (3) months of failed, conservative treatment, including use of anti-inflammatory medications at maximum specified dosage; epidural/facet injections, unless deemed inadvisable due to progressive motor weakness or other evidence of deteriorating condition; rest, heat, electrotherapy/physical therapy;
  3. Moderate to Severe narrowing of the lumbar spinal canal identified on CT /MRI scans
  4. Age 40-85 years old
  5. Lower back pain /sciatica with or without spinal claudication
  6. Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to the follow-up schedule.
  7. VAS leg pain of at least 40/100 at baseline.
  8. Oswestry Questionnaire score of at least 40/100 at baseline

Exclusion Criteria:

Patients who meet any of the following conditions or criteria are excluded from this study:

  1. Primary diagnosis of discogenic back pain at the TOPS System level
  2. Back or non-radicular leg pain of unknown etiology at the TOPS System level
  3. Lytic spondylolisthesis at the TOPS System level
  4. 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.
  5. Known allergy to titanium and/or polyurethane
  6. Prior surgery at any lumbar vertebral level.
  7. Supplemental interbody support required (e.g., VBRs, or fusion cages) at the TOPS System level
  8. Clinically compromised vertebral bodies at the affected level(s) due to any traumatic, neoplastic, metabolic or infectious pathology.
  9. Deformity of the spine that would compromise the implant, e.g. scoliosis of greater than ten (10) degrees
  10. Morbid obesity (a body mass index > 40) or a weight more than 100 lbs. over ideal body weight.
  11. DEXA bone density T score equal to or lower than - 2.0
  12. Paget's disease, osteomalacia, osteogenesis imperfecta, thyroid and/or parathyroid gland disorder and/or any other metabolic bone disease.
  13. Active infection - systemic or local
  14. AIDS, HIV, or active hepatitis
  15. Rheumatoid arthritis or other autoimmune disease.
  16. Tuberculosis active or in the past 3 years.
  17. Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.
  18. Medical conditions requiring treatment with any drugs known to potentially interfere with bone/soft tissue healing
  19. Pregnant or interested in becoming pregnant in the next 3 years.
  20. Current chemical/alcohol dependency or psychosocial disturbance.
  21. Cauda equina syndrome or neurogenic bowel/bladder dysfunction
  22. Severe arterial insufficiency of the legs, peripheral vascular disease
  23. Sustained pathologic fractures of the vertebra or multiple fractures of the vertebra or hip
  24. Unremitting pain in any spinal position
  25. Significant peripheral neuropathy
  26. Immunologically suppressed, received steroids > 1 month out of the past year aa. Insulin-dependent diabetes mellitus bb. Currently taking anticoagulants other than aspirin (e.g., Plavix) cc. Life expectancy less than 3 years dd. Waddell signs > 3 ee. Currently involved in active spinal litigation ff. Subject is incarcerated
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01933607

Contacts
Contact: Stephen McGillion, MD 02380796245 Stephen.McGillion@uhs.nhs.uk

Locations
United Kingdom
University Hospital Southampton NHS Foundation Trust Not yet recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Stephen McGillion, MD       Stephen.McGillion@uhs.nhs.uk   
Principal Investigator: John Fowler, MD         
Sponsors and Collaborators
Premia Spine
Investigators
Principal Investigator: John Fowler, MD University Southampton Hospital
  More Information

No publications provided

Responsible Party: Premia Spine
ClinicalTrials.gov Identifier: NCT01933607     History of Changes
Other Study ID Numbers: 1513-CL-VL-01 SOU UK
Study First Received: March 8, 2013
Last Updated: September 1, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Spinal Stenosis
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis

ClinicalTrials.gov processed this record on August 20, 2014