Back to resultsA Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System
Primary Purpose
Lower Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
TOPS™ System
Sponsored by
About this trial
This is an interventional treatment trial for Lower Back Pain
Eligibility 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
Sites / Locations
- Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lower Back and Leg Pain Patients
Arm Description
Patients suffering from lower back and leg pain resulting in degenerative spondylolisthesis and/or spinal stenosis will undergo treatment using the TOPS™ System
Outcomes
Primary Outcome Measures
Pain Improvement
Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score
Function Improvement
Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score
Fusion Prevention
The subjects will be considered a failure if fusion occurs as defined in the radiographic protocol
Secondary Outcome Measures
Full Information
NCT ID
NCT03247166
First Posted
August 9, 2017
Last Updated
August 9, 2017
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03247166
Brief Title
A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System
Official Title
A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2017 (Anticipated)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lower Back and Leg Pain Patients
Arm Type
Experimental
Arm Description
Patients suffering from lower back and leg pain resulting in degenerative spondylolisthesis and/or spinal stenosis will undergo treatment using the TOPS™ System
Intervention Type
Device
Intervention Name(s)
TOPS™ System
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain Improvement
Description
Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score
Time Frame
24 months
Title
Function Improvement
Description
Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score
Time Frame
24 months
Title
Fusion Prevention
Description
The subjects will be considered a failure if fusion occurs as defined in the radiographic protocol
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Safety
Description
Subjects with no serious device complications as defined in the radiological protocol
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilana Alony, RN
Phone
972-4-6304487
Email
ilanaa@hy.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eyal Behrbalk, MD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
H̱adera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilana Alony, RN
Phone
972-4-6304487
Email
ilanaa@hy.health.gov.il
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System
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