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

Hillel Yaffe Medical Center

Status: Unknown

Conditions: Lower Back Pain

Treatments: Device: TOPS™ System

Study type: Interventional

Funder types: Other

Identifiers

NCT03247166

HYMC-36-17

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Lower Back and Leg Pain Patients

Experimental group

Description:

Patients suffering from lower back and leg pain resulting in degenerative spondylolisthesis and/or spinal stenosis will undergo treatment using the TOPS™ System

Treatment:

Device: TOPS™ System