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

Sponsor
Hillel Yaffe Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03247166
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: TOPS™ System
 N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Sep 1, 2017
Anticipated Primary Completion Date :
Sep 1, 2019
Anticipated Study Completion Date :
Sep 1, 2019

Arms and Interventions

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

Primary Outcome Measures

  1. Pain Improvement [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 [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 [24 months]

    The subjects will be considered a failure if fusion occurs as defined in the radiographic protocol

Other Outcome Measures

  1. Safety [24 months]

    Subjects with no serious device complications as defined in the radiological protocol

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Hillel Yaffe Medical Center H̱adera Israel 38100

Sponsors and Collaborators

  • Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: Eyal Behrbalk, MD, Hillel Yaffe Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT03247166
Other Study ID Numbers:
  • HYMC-36-17
First Posted:
Aug 11, 2017
Last Update Posted:
Aug 11, 2017
Last Verified:
Aug 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
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:
Low Back Pain

Study Results

No Results Posted as of Aug 11, 2017