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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03247166
Recruitment Status : Unknown
Verified August 2017 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 11, 2017
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lower Back Pain Device: TOPS™ System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Device: 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


Outcome Measures
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Primary Outcome Measures :
  1. Pain Improvement [ Time Frame: 24 months ]
    Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score

  2. Function Improvement [ Time Frame: 24 months ]
    Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score

  3. Fusion Prevention [ Time Frame: 24 months ]
    The subjects will be considered a failure if fusion occurs as defined in the radiographic protocol


Other Outcome Measures:
  1. Safety [ Time Frame: 24 months ]
    Subjects with no serious device complications as defined in the radiological protocol


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247166


Contacts
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Contact: Ilana Alony, RN 972-4-6304487 ilanaa@hy.health.gov.il

Locations
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Israel
Hillel Yaffe Medical Center
H̱adera, Israel, 38100
Contact: Ilana Alony, RN    972-4-6304487    ilanaa@hy.health.gov.il   
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
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Principal Investigator: Eyal Behrbalk, MD Hillel Yaffe Medical Center
More Information
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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT03247166    
Other Study ID Numbers: HYMC-36-17
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Low Back Pain
Back Pain
Pain
Neurologic Manifestations