N/A
Completed N=291
Post Approval Study Protocol for the Two Level Simplify® Cervical Artificial Disc
Cervical Degenerative Disc Disorder
Source: ClinicalTrials.gov NCT04980378 ↗
Enrolled (actual)
291
Serious AEs
32.3%
Results posted
Mar 2025
Primary outcomePrimary: Clinical Composite Success — 127; 84 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 two-level Simplify Disc Investigational Device Exemption (IDE) study. This study was conducted under IDE G150206
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Composite Success |
127; 84 | — |
| SECONDARY Clinically Significant Improvement in One or More Radicular Symptoms or Myelopathy |
125; 90 | — |
| SECONDARY Health Survey; 36-Item Short Form Survey (SF-36) - Physical Component Score (PCS) Maintenance or Improvement |
122; 86; 13; 18 | — |
| SECONDARY Health Survey; 36-Item Short Form Survey (SF-36) - Mental Component Score (MCS) Maintenance or Improvement |
110; 80; 25; 24 | — |
| SECONDARY Dysphagia Handicap Index (DHI Scale) |
7.1 | — |
| SECONDARY Patient Satisfaction |
116; 77; 22; 24; 3; 4 | — |
| SECONDARY Physician's Perception |
126; 57; 10; 41; 5; 8 | — |
| SECONDARY Change in Average Disc Height (Superior Index Level) |
1.10 | — |
| SECONDARY Change in Average Disc Height (Inferior Index Level) |
0.81 | — |
| SECONDARY Adjacent Level Deterioration - Superior Adjacent Level |
70; 41; 20; 5; 1 | — |
| SECONDARY Adjacent Level Deterioration - Inferior Adjacent Level |
81; 23; 13; 5; 2 | — |
| SECONDARY Displacement or Migration of the Device |
0; 0; 140; 102 | — |
Eligibility Criteria
Inclusion Criteria
- All subjects enrolled in the two level 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- Subjects who were withdrawn or withdrew consent to participate in the IDE study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 (NCT04980378). 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.