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NCT03247166 Clinical Trial

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

Lower Back Pain Clinical Trial

Official title:
A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03247166
Other study ID # HYMC-36-17
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 9, 2017
Last updated August 9, 2017
Start date September 2017
Est. completion date September 2019

Study information
Verified date August 2017
Source Hillel Yaffe Medical Center
Contact Ilana Alony, RN
Phone 972-4-6304487
Email ilanaa@hy.health.gov.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The TOPS™ SP System is intended to provide stabilization in skeletally mature patients. The system is designed to afford motion of the spine segment without fusion. The pur0pose of this prospective clinical study is to establish the safety and effectiveness of the TOPS™ System, when used following decompression, in the treatment of lower back and sciatic pain.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10
Est. completion date September 2019
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 85 Years
Eligibility Inclusion Criteria:

- Patients with symptomatic monosegmental lumbar spinal stenosis or facet arthrosis

- Patients with degenerative spondylolisthesis

- Patients with at least 3 months failed conservative treatment

- Narrowing of the lumbar spinal canal

- Patients with lower back pain or sciatica

Exclusion Criteria:

- Discogenic back pain at TOPS System level

- Back or non-radicular leg pain of unknown etiology at TOPS System level

- Lytic spondylolisthesis at TOPS System level

- More than one motion segment involved in degenerative pathology to the extent that justifies its inclusion in the surgical procedure

- Known allergy to titanium and/or polyurethane

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• TOPS™ System
The TOPS™ System is an alternative to spinal fusion that is designed to stabilize but not fuse the effected vertebrai level to alleviate pain stemming from degenerative joints

Locations
Country Name City State
Israel Hillel Yaffe Medical Center H_adera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Other Safety Subjects with no serious device complications as defined in the radiological protocol 24 months
Primary Pain Improvement Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score 24 months
Primary Function Improvement Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score 24 months
Primary Fusion Prevention The subjects will be considered a failure if fusion occurs as defined in the radiographic protocol 24 months
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