N/A
Completed N=248
Post-Approval Study Protocol for the Simplify Cervical Artificial Disc
Cervical Degenerative Disc Disorder
Source: ClinicalTrials.gov NCT04630626 ↗
Enrolled (actual)
248
Serious AEs
17.7%
Results posted
May 2024
Primary outcomePrimary: Number of Participants With Clinical Composite Success, Parent IDE Study + Post Approval Study (PAS) — 117; 40 Participants
Summary
This study is intended to demonstrate the 5-year long-term safety and efficacy of the Simplify® Cervical Artificial Disc ("Simplify Disc") in subjects enrolled in the non-randomized Simplify Disc IDE study. This study was conducted under IDE G140154.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Composite Success, Parent IDE Study + Post Approval Study (PAS) |
117; 40 | — |
| SECONDARY Number of Participants With Clinical Improvement in One or More Radicular Symptoms or Myelopathy (Neurological Status), Parent IDE Study + Post Approval Study (PAS) |
97; 23 | — |
| SECONDARY Clinical Improvement in One or More Radicular Symptoms or Myelopathy (Visual Analog Scale), Parent IDE Study + Post Approval Study (PAS) |
16.8; 23.8 | — |
| SECONDARY Participants Average Disc Height, Parent IDE Study + Post Approval Study (PAS) |
4.06; 4.81 | — |
| SECONDARY Percentage of Participants With No Adjacent Level Disc Deterioration (ALDD) Superior Level, Parent IDE Study + Post Approval Study (PAS) |
52; 6 | — |
| SECONDARY Percentage of Participants With No Adjacent Level Disc Deterioration (ALDD) Inferior Level, Parent IDE Study + Post Approval Study (PAS) |
59; 10 | — |
| SECONDARY Percentage of Participants With No Displacement or Migration of the Device, Parent IDE Study + Post Approval Study (PAS) |
100; 95 | — |
| SECONDARY Percentage of Participants Reporting Overall Treatment Satisfaction of "Very Satisfied" or "Satisfied", Parent IDE Study + Post Approval Study (PAS) |
83; 75; 84; 62 | — |
| SECONDARY Participants With Maintenance or Improvement on 12-Item Short Form Survey (SF-12), Parent IDE Study + Post Approval Study (PAS) |
96; 71.8 | — |
| SECONDARY Percentage of Participants With No Dysphagia Handicap Index (DHI), Parent IDE Study + Post Approval Study (PAS) |
97; 100 | — |
Eligibility Criteria
Inclusion Criteria
- All subjects enrolled in the Simplify Disc IDE study are considered for this long-term follow-up study.
Exclusion Criteria
- Subjects who were not implanted with the Simplify Disc during the IDE study
- Subjects who had a secondary surgical intervention at the index level during the IDE study
- Subjects who were withdrawn or withdrew consent to participate in the IDE study
- Subjects who do not consent to participate in long-term follow-up post-approval study
Data sourced from ClinicalTrials.gov (NCT04630626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.