A Study to Evaluate the Safety and Effectiveness of TOPS(TM) System

Spondylolisthesis Clinical Trial

Official title:

A Study to Evaluate the Safety and Effectiveness of the Premia Spine TOPS(Total Posterior Spine) System.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02234154
• Other study ID #: 1513-CL-TP-01 NOT UK
• Status: Recruiting
• Phase: N/A
• First received: September 4, 2014
• Last updated: October 19, 2015
• Start date: December 2014
• Est. completion date: May 2017

Study information

• Verified date: October 2015
• Source: Premia Spine
• Contact: Masood Shafafy, MD
• Phone: +44 (0)115 9249924
• Email: massod.shafafy[@]nuh.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The study will primarily look at the effectiveness of the TOPS (Total Posterior Spine) System when used in patients with lumbar spine stenosis (narrowing of the spinal canal) who would normally be candidates for spinal fusion.

Description:

This study is being conducted in order to evaluate the TOPS™ SP System from Premia Spine (referred to as "TOPS™ System" or "TOPS"). The TOPS™ System is an alternative to spinal fusion that is designed to stabilize but not fuse the affected vertebral level to alleviate pain stemming from degenerative spondylolisthesis, and spinal stenosis. Facet arthrosis is the inflammation and enlargement of the facet joints. Degenerative spondylolisthesis refers to abnormal and excessive movement of the vertebrae, causing pain in the lower back and legs. Spinal stenosis is a condition where compression of nerves produces symptoms of pain, numbness and tingling in the legs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Any subject meeting all of the following criteria will be considered acceptable 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 implant:

• 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 prior to surgery, including use of anti-inflammatory medications at maximum specified dosage; administration of epidural/facet injections, unless deemed inadvisable due to progressive motor weakness or other evidence of rapidly deteriorating condition; rest, heat, electrotherapy/physical therapy;

3. Narrowing of the lumbar spinal canal (central and/or foramenal) classified as moderate to severe using CT scans/MRI

4. Age 40-85 years old (male or female)

5. Lower back pain or sciatica with or without spinal claudication

6. Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.

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 have any of the following conditions or meet any of the following criteria are excluded from participating in 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. Supplemental interbody support required (e.g., bone graft, spacers, VBRs, or fusion cages) at the TOPS System level

7. Clinically compromised vertebral bodies at the affected level(s) due to any traumatic, neoplastic, metabolic or infectious pathology.

8. Deformity of the spine that would compromise the implant, e.g. scoliosis of greater than ten (10) degrees

9. Morbid obesity defined as a body mass index > 40 or a weight more than 100 lbs. over ideal body weight.

10. DEXA bone density measured T score equal to or lower than - 2.0

11. Paget's disease, osteomalacia, osteogenesis imperfecta, thyroid and/or parathyroid gland disorder and/or any other metabolic bone disease.

12. Active infection - systemic or local

13. AIDS, HIV, or active hepatitis

14. Rheumatoid arthritis or other autoimmune disease.

15. Tuberculosis active or in the past 3 years.

16. 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.

17. Medical conditions requiring treatment with any drugs known to potentially interfere with bone/soft tissue healing

18. Pregnant or interested in becoming pregnant in the next 3 years.

19. Current chemical/alcohol dependency or significant psychosocial disturbance.

20. Cauda equina syndrome or neurogenic bowel/bladder dysfunction

21. Severe arterial insufficiency of the legs, peripheral vascular disease

22. Sustained pathologic fractures of the vertebra or multiple fractures of the vertebra or hip

23. Significant peripheral neuropathy

24. Immunologically suppressed, received steroids > 1 month out of the past year

25. Insulin-dependent diabetes mellitus

26. Life expectancy less than 3 years aa) Waddell signs > 3 bb) Currently involved in active spinal litigation cc) Subject is incarcerated

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lumbar Spine Stenosis
• Spondylolisthesis

Intervention

Device:
• TOPS device
Spinal surgery

Locations

Country	Name	City	State
United Kingdom	Queens Medical Centre	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
Premia Spine

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in VAS score	Pain/Function/Disability at 24-month evaluation: Subjects who exhibit a reduction of 15 percent in their Oswestry Low Back Pain Disability Questionnaire score compared to their preoperative Oswestry score will be considered a success. Beurkens et al. has reported a change of 4 to 6 points of the 100 points for the Oswestry to represent a clinically significant improvement AND Subjects who exhibit a reduction of 20mm in either of their VAS Leg Score.; Radiographic: Any TOPS subject will be considered a failure if fusion occurs as defined in the radiographic protocol.	Post operatively to 2 years	No
Secondary	SF-36 Quality of Life	Although the main goal of this trial is to address the primary endpoint of overall effectiveness at 24 months, individual outcome endpoints will be evaluated and will include average improvement in back and leg visual analog scales (VAS), ZCQ scores, quality of life (SF-36), and maintenance or improvement in neurological symptoms. When possible, other factors such as vertebral range of motion, disc height, length of stay, OR time, blood loss, work status pre-surgery, return to work status, time to recovery and narcotic use will be evaluated. An economic analysis of patient and hospital costs may also be performed.	Post operatively to 2 years	No