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

Spinal Stenosis Clinical Trial

Official title:

A Study To Evaluate The Safety And Effectiveness Of TOPS™ System In The Lumbar Spine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01933607
• Other study ID #: 1513-CL-VL-01 SOU UK
• Status: Recruiting
• Phase: N/A
• First received: March 8, 2013
• Last updated: October 19, 2015
• Start date: May 2014
• Est. completion date: December 2016

Study information

• Verified date: October 2015
• Source: Premia Spine
• Contact: Stephen McGillion, MD
• Phone: 02380796245
• Email: Stephen.McGillion[@]uhs.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Stenosis
• Spondylolisthesis

Intervention

Device:
• TOPS System
TOPS™ System Post Marketing Study To Evaluate The Safety And Effectiveness Of TOPS™ in the Lumbar Spine

Locations

Country	Name	City	State
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Premia Spine

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS (Visual Analog Score)	Pain assessment	2 YEARS	No
Secondary	SF-36 (Short-Form)	Quality of life	2 YEARS	No