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

Not Applicable

• Conditions: Lower Back Pain
• Interventions: Device: TOPS™ System

• Registration Number: NCT03247166
• Lead Sponsor: Hillel Yaffe Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-09
• Last Update Submitted: 2017-08-09
• Study First Posted: 2017-08-11
• Last Update Posted: 2017-08-11
• Study Start: 2017-09
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

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

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lower Back and Leg Pain Patients	TOPS™ System	Patients suffering from lower back and leg pain resulting in degenerative spondylolisthesis and/or spinal stenosis will undergo treatment using the TOPS™ System

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 H̱adera, Israel