Safety and effectiveness of TOPS™ System

Not Applicable

Completed

• Conditions: Surgery; Single Level Lumbar Spine Stenosis (with up to a grade 1 spondylolisthesis)

• Registration Number: ISRCTN47205504
• Lead Sponsor: Premia Spine Ltd (Israel)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-02
• Study Completion: 2015-11-30
• Last Update Posted: 26 March 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

The study population will be comprised of patients suffering from lower back and leg pain which results from degenerative spondylolisthesis and/or spinal stenosis who meet the eligibility criteria as follows
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:
1.1. Symptomatic monosegmental lumbar spinal stenosis
1.2. Degenerative Spondylolisthesis up to and including grade 1 (see radiographic protocol)
2. Patients with one or more of the following conditions at one or two levels adjacent to the TOPS System between L4 and S1 are eligible for the Versalink™ Fixation System implant:
2.1. Symptomatic monosegmental lumbar spinal stenosis
2.2. Degenerative Spondylolisthesis up to and including grade 1 (see radiographic protocol)
2.3. Discogenic pathology
3. 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
4. Narrowing of the lumbar spinal canal classified as moderate to severe using CT scans/MRI
5. Age 40-85 years old (male or female)
6. Lower back pain and sciatica with or without spinal claudication
7. Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
8. Leg pain of at least 40/100 at baseline as per visual analogue scale (VAS)
9. 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 or the Versalink System is implanted.
5. Known allergy to titanium and/or polyurethane
6. Prior surgery at any lumbar vertebral level
7. Supplemental interbody support required (e.g., bone graft, spacers, 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 defined as a body mass index > 40 or a weight more than 100 lbs. over ideal body weight
11. DEXA bone density measured 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 significant psychosocial disturbance
21. Subject is currently involved in another investigational study
22. Cauda equina syndrome or neurogenic bowel/bladder dysfunction
23. Severe arterial insufficiency of the legs, peripheral vascular disease
24. Sustained pathologic fractures of the vertebra or multiple fractures of the vertebra or hip
25. Unremitting pain in any spinal position
26. Significant peripheral neuropathy
27. Immunologically suppressed, received steroids > 1 month out of the past year
28. Insulin-dependent diabetes mellitus
29. Currently taking anticoagulants other than aspirin (e.g., Plavix)
30. Life expectancy less than 3 years
31. Waddell signs > 3
32. Currently involved in active spinal litigation
33. Subject is incarcerated

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Individual Patient Success<br>2. 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<br>3. Subjects who exhibit a reduction of 20mm in their VAS Leg Score (combined leg score)<br>4. Radiographic: Any TOPS subject will be considered a failure if fusion occurs as defined in the radiographic protocol

Secondary Outcome Measures

Name	Time	Method
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 for each study group may also be performed.