|
|
| General |
| Study Status |
Ongoing |
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
|
| Follow-up Visits and Length of Follow-up |
Annually through 60 months after surgery.
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results:
There was a total of 56 SAEs in 39 subjects in the PAS Analysis Set in the available data. The SAE rate was 24.4%, (39/160 subjects) with the majority of SAEs related to musculoskeletal and connective tissue disorders (20/56 events). 26 out of 56 SAEs of SAEs occurred beyond day 729.
There was 1 device related and 3 procedure related SAEs. There is no current evidence that these event rates increase over time.
Effectiveness Results:
Preliminary data appears to show steady 15 point NDI improvement rates across given timepoints (91.6% at Month 24; 94.0% at Month 36; 95.2% at Month 48; 90.0% at Month 60)
Neurological function (sensory and motor) appears to maintain across all timepoints
One SSI has been reported for the PAS cohort (implant removal and fusion due to implant subsidence)
Radiographic evaluations do not show problematic failure trends
One device related SAE has been reported for the PAS cohort (adjacent segment disease)
|
| Actual Number of Patients Enrolled |
160
|
| Actual Number of Sites Enrolled |
20
|
| Patient Follow-up Rate |
Month 24: 91%
Month 36: 75%
Month 48: 67%
Month 60: 67%
|
