A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2017
CompletedFirst Posted
Study publicly available on registry
August 11, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedAugust 11, 2017
August 1, 2017
2 years
August 9, 2017
August 9, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
Fusion Prevention
The subjects will be considered a failure if fusion occurs as defined in the radiographic protocol
24 months
Other Outcomes (1)
Safety
24 months
Study Arms (1)
Lower Back and Leg Pain Patients
EXPERIMENTALPatients suffering from lower back and leg pain resulting in degenerative spondylolisthesis and/or spinal stenosis will undergo treatment using the TOPS™ System
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- 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
- Known allergy to titanium and/or polyurethane
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hillel Yaffe Medical Center
Hadera, 38100, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eyal Behrbalk, MD
Hillel Yaffe Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2017
First Posted
August 11, 2017
Study Start
September 1, 2017
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
August 11, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share