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|
| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P250028 / PAS001 |
| Date Original Protocol Accepted |
04/09/2026
|
| Date Current Protocol Accepted |
04/09/2026
|
| Study Name |
Continued Follow-up Study
|
| Device Name |
Synergy Disc
|
| Clinical Trial Number(s) |
NCT04469231
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Continued follow-up of a multi-center, prospective, non-randomized, historically controlled to evaluate the 5-year long-term safety and effectiveness of the Synergy Disc.
|
| Study Population |
Subjects implanted with the Synergy Disc during the IDE Study
|
| Sample Size |
Number of subjects: Up to 160 patients
Assumptions for sample size estimation: Continued study participation from subjects available from the As Treated Analysis Set who were enrolled in the pivotal study
Number of sites: Up to 20 study sites
Sites location: United States
|
| Key Study Endpoints |
Primary: The primary safety endpoints for the post approval study are serious adverse events (SAEs), and device- or procedure-related adverse events (AEs).
Secondary: Additional safety analyses will include the rate of AEs, including by relatedness to device or procedure and severity (mild, moderate, or severe), time-to-event, including mean and ranges if applicable, and Subsequent Surgical Intervention (SSI) by rate and type.
Effectiveness Endpoints
Primary: The primary endpoint of the investigation is individual patient success, which requires the patient to meet all of the following criteria at 60 months:
Greater than or equal to 15-point improvement in NDI Score (out of 100) in subjects at 60 months compared with baseline;
Maintenance or improvement in neurological status (motor and sensory only) at 60 months compared to baseline;
No study failure due to secondary surgical interventions (revision, removal, re-operation, supplemental fixation) at the index level;
Absence of radiographic failure, defined as any implant or component breakage or migration at the index level
Absence of device-related Serious Adverse Event as adjudicated by the CEC
Secondary: The following secondary evaluations will be collected:
Health Survey (SF-36) at baseline and at each follow-up time-point
Visual analogue scale (VAS) will be used to evaluate pain where a change of at least 20mm will be considered clinically significant
Neck pain as measured on a 100mm VAS at baseline and at each follow-up time-point
Left and Right arm/shoulder pain as measured on a 100mm VAS at baseline and at each follow-up timepoint. Please note, this assessment will include a “Worst” to pool together the left or right arm/shoulder scores with the higher baseline score.
Patient Satisfaction
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| Follow-up Visits and Length of Follow-up |
Annually through 60 months after surgery.
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