A study to evaluate the safety and effectiveness of TOPS™ System: a non-randomized single centre study

Premia Spine Ltd (Israel)0 sites10 target enrollmentAugust 2, 2013

Overview

Phase: 未知
Intervention: Not specified
Conditions: Single Level Lumbar Spine Stenosis (with up to a grade 1 spondylolisthesis)
Sponsor: Premia Spine Ltd (Israel)
Enrollment: 10
Status: Completed
Last Updated: 8 years ago

No summary available.

Registry

who.int

Start Date

August 2, 2013

End Date

November 30, 2015

Last Updated

8 years ago

Study Type

Interventional

Sex

All

Sponsor

Premia Spine Ltd (Israel)

•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

•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