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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03247166

Enrollment

Registered

2017-08-11

Start date

2017-09-30

Completion date

2019-09-30

Last updated

2017-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Back Pain

Brief 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.

Interventions

DEVICETOPS™ 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Fusion Prevention	24 months	The subjects will be considered a failure if fusion occurs as defined in the radiographic protocol
Pain Improvement	24 months	Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score
Function Improvement	24 months	Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score

Other

Measure	Time frame	Description
Safety	24 months	Subjects with no serious device complications as defined in the radiological protocol

Countries

Israel

Contacts

Primary ContactIlana Alony, RN

ilanaa@hy.health.gov.il972-4-6304487

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026