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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P220002 / PAS001 |
| Date Original Protocol Accepted |
08/11/2023
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| Date Current Protocol Accepted |
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| Study Name |
The TOPS System Continued F/U Study
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| Device Name |
TOPS™ System
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| Clinical Trial Number(s) |
NCT01933607 NCT02234154 NCT03012776
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| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of this prospective, randomized, concurrently controlled, multi-center study is to evaluate the safety and effectiveness of the TOPS™ System versus to lumbar spinal fusion control.
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| Study Population |
Participants in the IDE study who failed at least 6 months of conservative therapy for treatment of leg pain with or without back pain at one vertebral level between L2 and L5 stemming from (1) moderate to severe central, foraminal, and/or subarticular recess lumbar spinal stenosis (LSS) and (2) up to Grade I degenerative spondylolisthesis or equivalent retrolisthesis and (3) thickening of the ligamentum flavum or scaring facet joint capsule.
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| Sample Size |
A total of 299 subjects in the Per Protocol analysis set (206 TOPS, 93 fusion control) who were enrolled into the Pivotal study and are continuing follow up to 5 years. Assuming 85% compliance, it implies 175 TOPS subjects and 79 Fusion controls. If compliance in controls is only 80%, this implies a control sample size of 74.
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| Key Study Endpoints |
Primary Effectiveness Endpoint:
The primary effectiveness endpoint is a composite clinical success (CCS) responder endpoint based on clinical status at Month 60. An individual subject will be regarded as achieving Month 60 CCS only if s/he meets all of the following criteria at 60-months compared to baseline:
A reduction of 15 points or more in the 60-month Oswestry Disability Index (ODI) compared to baseline;
No new or worsening, persistent neurologic deficit;
No epidural steroid injection, facet joint injections, nerve block procedures or implantable spinal cord stimulator to treat back or leg pain symptoms at any lumbar level;
Any TOPS subject will be considered a failure if fusion occurs as defined in the radiographic protocol. Any Fusion subject will be considered a failure if fusion (as defined in the radiographic protocol) does not occur. This assessment will be made by a core lab;
No revision or removal of implants;
No supplemental fixation at the index level or at the immediately adjacent levels;
No occurrence of a major device related adverse event.
Secondary Endpoints:
Individual components of 60-month composite clinical success (CCS);
CCS at Months 36 and 48;
ODI, changes from baseline in ODI, and 15 point improvement in ODI;
Visual analog scale (VAS) for back pain and worse leg pain, changes from baseline in VAS, and 20 mm improvement in VAS; for VAS, the higher of the two leg scores at baseline will be used for analysis purposes.
ZCQ findings;
o Improvement of greater than or equal to 0.5in ZCQ physical symptom score and symptom severity and less than or equal to 2.5 on ZCQ subject satisfaction over time.
o Overall ZCQ success defined as meeting all 2 of 3 individual ZCQ success criteria.
o Overall ZCQ success defined as meeting all three individual ZCQ success criteria.
Reduction in physical component score on SF-12;
Time to revision or removal, or supplemental fixation at index or adjacent level;
Narcotics use for lower back pain and leg pain;
Range of motion in flexion/extension at the index and immediately adjacent levels
Safety Endpoint:
Evaluation of the incidence and severity of complications and adverse reactions associated with the treatment.
The following AE listings will be constructed:
All AEs Sorted by Group and Event Type
All AEs Sorted by Group and Subject
Serious AEs
Severe AEs
Device Related AEs
Serious Device Related AEs
Severe Device Related AEs
Severe Life-Threatening AEs
Procedure Related AEs
Other AEs
AEs among subjects discontinued early
AEs among subjects who died.
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| Follow-up Visits and Length of Follow-up |
After 24-month follow-up visit, the subject will continue to be followed long term annual post 24 months, at 36, 48, until patient reaches 60 months.
60 months (5 years) post-implant
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| Interim or Final Data Summary |
| Interim Results |
Safety Results
Overall TOPS continues to demonstrate comparable adverse event rates as compared to the Fusion control. Subjects reporting any AE in the TOPS group is 79.1% vs 74.5% for the Fusion group. The percentage of subjects reporting device related AEs in the TOPS group was 25.1% vs 31.6% for the Fusion control. The percentage of subjects reporting procedure related AEs for the TOPS groups was 55.0% vs 55.1% for the Fusion control. SAEs are reported more frequently in the TOPS group vs Fusion (38.4% vs 26.5%) however there is no difference between the treatment groups when comparing SAEs that are either device related or procedure related.
Device related SAEs are reported in 5.7% of TOPS patients and 6.1% of Fusion patients. Procedure related SAEs are reported in 15.6% of TOPS patients and 12.2% of Fusion patients.
Effectiveness Results:
Overall composite clinical success (CCS) rates are all timepoints are not yet available.
One component of CCS was a minimum improvement in the Oswestry Disability Index (ODI) of at least 15 points. At the time of PMA approval, 94.7% of the investigative group improved by at least 15 points at Month 24. The available ODI information shows similar rates of improvement across later timepoints.
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| Actual Number of Patients Enrolled |
309
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| Actual Number of Sites Enrolled |
37
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| Patient Follow-up Rate |
Month 6: Investigative (I): 98%; Control (C): 94.6%
Month 12: I: 97%; C: 93.3%
Month 24: I: 96%; C: 89.9%
Month 36: I: 92.2%; C: 72.5%
Month 48: I: 88.4%; C: 66.7%
Month 60: I: 83.3%; C: 78.6%
Five (5) subjects considered lost to follow up.
Among the 309 mITT patients taken to surgery as part of the IDE, 25 patients have terminated early, including 4 patients (2 TOPS, 2 Fusion) that were considered withdrawn from the study intraoperatively due to the operating surgeon’s dec
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