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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P220031 / PAS001 |
| Date Original Protocol Accepted |
04/08/2026
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| Date Current Protocol Accepted |
04/08/2026
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| Study Name |
LimiFlex Dynamic Sagittal Tether Cont F/U Study
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| Device Name |
LimiFlex Dynamic Sagittal Tether
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| Clinical Trial Number(s) |
NCT03115983
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
A descriptive prospective, single-center, single-arm study design.
To evaluate the 5-year long-term safety and effectiveness of the LimiFlex Dynamic Sagittal Tether™.
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| Study Population |
Enrollment of the patients included in the original PMA cohort (LimiFlex Dynamic Sagittal Tether™ study), who are evaluable for the long term 5 year follow up, which includes at least 124 LimiFlex Dynamic Sagittal Tether™ subjects in the Intent-to-Treat, Propensity Score Selected (ITT PS-Selected) population who were enrolled in the Pivotal study.
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| Sample Size |
Number of subjects: 124
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| Key Study Endpoints |
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 they meet all of the following criteria at Month 60 compared to baseline:
5. Improvement of at least 15 points (100-point scale) on the Oswestry Disability Index (ODI) from baseline compared to 60 months.
6. Absence of a decrease in neurologic status (motor or sensory) at Month 60 compared to baseline unless attributable to a concurrent medical condition or other cause unrelated to the device and/ or study procedure.
7. Absence of additional surgical intervention, defined as revision, removal, reoperation or supplemental fixation/fusion, in a separate surgery subsequent to the index procedure, at the instrumented level or levels adjacent to the instrumented level, over the 60 months.
8. Absence of device integrity failures, defined as device breakage, device separation or disassembly, or device dislocation, over the 60 months.
Secondary Endpoints:
In addition, at Month 60, individual subjects will be assessed for the following endpoints:
3. No occurrence of any spinous process fractures at the implanted level (entire functional spine unit (FSU) instrumented with the subject device) up to 60-months follow-up and the time of occurrence relative to original index LimiFlex implant surgery.
No occurrence of a major device-related adverse event. This includes no occurrence of device integrity failure, including but not limited to subsidence, migration and dislodgement at the LimiFlex implant level (entire FSU instrumented with the subject device).
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| Follow-up Visits and Length of Follow-up |
Clinical follow-up evaluations will be conducted at 6 weeks, and 3, 6, 12, 24, 36, 48 and 60 months.
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