A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System
NCT ID: NCT03247166
Last Updated: 2017-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2017-09-30
2019-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lower Back and Leg Pain Patients
Patients suffering from lower back and leg pain resulting in degenerative spondylolisthesis and/or spinal stenosis will undergo treatment using the TOPS™ System
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
85 Years
ALL
No
Sponsors
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Hillel Yaffe Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Eyal Behrbalk, MD
Role: PRINCIPAL_INVESTIGATOR
Hillel Yaffe Medical Center
Locations
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Hillel Yaffe Medical Center
Hadera, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HYMC-36-17
Identifier Type: -
Identifier Source: org_study_id
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