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

This study is not yet open for participant recruitment.
Verified August 2017 by Hillel Yaffe Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03247166
First Posted: August 11, 2017
Last Update Posted: August 11, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
  Purpose
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 Intervention
Lower Back Pain Device: TOPS™ System

Study Type: Interventional
Study Design: 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

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • 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

  • 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

  • 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:
  • Safety [ Time Frame: 24 months ]
    Subjects with no serious device complications as defined in the radiological protocol


Estimated Enrollment: 10
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
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
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
Contact: Ilana Alony, RN 972-4-6304487 ilanaa@hy.health.gov.il

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
H̱adera, Israel, 38100
Contact: Ilana Alony, RN    972-4-6304487    ilanaa@hy.health.gov.il   
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
Principal Investigator: Eyal Behrbalk, MD Hillel Yaffe Medical Center
  More Information

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT03247166     History of Changes
Other Study ID Numbers: HYMC-36-17
First Submitted: August 9, 2017
First Posted: August 11, 2017
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms