TOPS™ System Post Marketing Study To Evaluate The Safety And Effectiveness Of TOPS™ System
Verified December 2014 by Premia Spine
Information provided by (Responsible Party):
First received: March 8, 2013
Last updated: December 17, 2014
Last verified: December 2014
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.
Device: TOPS System
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Study To Evaluate The Safety And Effectiveness Of TOPS™ System In The Lumbar Spine
Primary Outcome Measures:
- VAS (Visual Analog Score) [ Time Frame: 2 YEARS ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- SF-36 (Short-Form) [ Time Frame: 2 YEARS ] [ Designated as safety issue: No ]
Quality of life
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2016 (Final data collection date for primary outcome measure)
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
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.
|Ages Eligible for Study:
||40 Years to 85 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Any subject meeting the following criteria will be considered for inclusion in this trial.
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
- 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;
- Moderate to Severe narrowing of the lumbar spinal canal identified on CT /MRI scans
- Age 40-85 years old
- Lower back pain /sciatica with or without spinal claudication
- Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to the follow-up schedule.
- VAS leg pain of at least 40/100 at baseline.
- Oswestry Questionnaire score of at least 40/100 at baseline
Patients who meet any of the following conditions or criteria are excluded from this study:
- Primary diagnosis of discogenic back pain at the TOPS System level
- Back or non-radicular leg pain of unknown etiology at the TOPS System level
- Lytic spondylolisthesis at the TOPS System level
- 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 surgery at any lumbar vertebral level.
- Supplemental interbody support required (e.g., VBRs, or fusion cages) at the TOPS System level
- Clinically compromised vertebral bodies at the affected level(s) due to any traumatic, neoplastic, metabolic or infectious pathology.
- Deformity of the spine that would compromise the implant, e.g. scoliosis of greater than ten (10) degrees
- Morbid obesity (a body mass index > 40) or a weight more than 100 lbs. over ideal body weight.
- DEXA bone density T score equal to or lower than - 2.0
- Paget's disease, osteomalacia, osteogenesis imperfecta, thyroid and/or parathyroid gland disorder and/or any other metabolic bone disease.
- Active infection - systemic or local
- AIDS, HIV, or active hepatitis
- Rheumatoid arthritis or other autoimmune disease.
- Tuberculosis active or in the past 3 years.
- 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.
- Medical conditions requiring treatment with any drugs known to potentially interfere with bone/soft tissue healing
- Pregnant or interested in becoming pregnant in the next 3 years.
- Current chemical/alcohol dependency or psychosocial disturbance.
- Cauda equina syndrome or neurogenic bowel/bladder dysfunction
- Severe arterial insufficiency of the legs, peripheral vascular disease
- Sustained pathologic fractures of the vertebra or multiple fractures of the vertebra or hip
- Unremitting pain in any spinal position
- Significant peripheral neuropathy
- 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
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
|University Hospital Southampton NHS Foundation Trust
|Southampton, United Kingdom, SO16 6YD |
|Contact: Stephen McGillion, MD Stephen.McGillion@uhs.nhs.uk |
|Principal Investigator: John Fowler, MD |
||John Fowler, MD
||University Southampton Hospital
No publications provided
History of Changes
|Other Study ID Numbers:
||1513-CL-VL-01 SOU UK
|Study First Received:
||March 8, 2013
||December 17, 2014
||United Kingdom: Research Ethics Committee
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 25, 2015