Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc
Study Details
Study Description
Brief Summary
A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc in subjects who were enrolled in the post approval study (NCT04630626).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Simplify Disc Extended follow-up of subjects treated with the Simplify Disc during IDE G140154 and followed in the post-approval study NCT04630626. |
Device: NuVasive Simplify Cervical Artificial Disc
Simplify Disc is a weight-bearing cervical artificial disc implant consisting of PEEK (polyetheretherketone) endplates and one semi-constrained, fully articulating, mobile Zirconia Toughened Alumina ceramic (ZTA) core.
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Outcome Measures
Primary Outcome Measures
- Clinical Composite Success [10 years]
Individual patient success for the primary endpoint will be assessed at 120 months and is defined as follows: Improvement on the Neck Disability Index (NDI) of at least 15 percentage points compared to baseline (pre-op), and No device failures by month 120, and No secondary surgical intervention (SSI) at the index level (i.e., revision, removal, reoperation, or supplemental fixation) by month 120.
Secondary Outcome Measures
- Percentage of subjects meeting the minimal clinically important difference (MCID) for NDI at each annual timepoint [10 years]
Neck Disability Index; scale is reported in a range from 0-100, with 0 consistent with best ability to function and 100 worst ability to function.
- Percentage of subjects meeting MCID for Visual Analog Scale (VAS) for each of the following pain locations and each annual timepoint: neck and arm pain, neck only pain, left arm pain, and right arm pain [10 years]
Visual Analog Scale, scale is reported in a range from 0 to 100, with 0 consistent with no pain and 100 with most pain
- Motor status at each annual timepoint compared to baseline [10 years]
A change of one or more grade levels in muscle strength will be regarded as clinically significant.
- Sensory status at each annual timepoint compared to baseline [10 years]
Sensation will be graded as normal or abnormal (diminished or absent). Any changes from abnormal to normal or absent to diminished will be regarded as clinically significant improvement.
- Treatment satisfaction questionnaire at each annual timepoint [10 years]
Responses range from very dissatisfied to very satisfied
- SF-12v2® Health Survey at each annual timepoint compared to baseline [10 years]
The SF-12 is a multipurpose short form survey with 12 questions selected from the SF-36 Health Survey. The questions were combined, scored and weighted to create mental and physical functioning and overall health-related quality of life. Higher scores indicate better outcomes. Scores range from 0-15.
- Dysphagia Handicap Index1 (DHI) at each annual timepoint compared to baseline [10 years]
DHI is scored from 0-100, with a higher score indicative of a less desirable outcome.
- Disc height at each annual timepoint will be compared to baseline [10 years]
Average disc height is calculated as the simple average of the anterior and posterior disc heights
- Adjacent level disc degeneration (ALDD) at each annual timepoint will be compared to baseline [10 years]
ALDD is graded in accordance with definitions adapted from Kellgren and Lawrence: None; Doutbtful;Minimal;Moderate;Severe
- Displacement or migration of the Simplify Disc at each annual timepoint will be compared to the post-op timepoint in the IDE study (NCT02667067) [10 years]
Device migration assesses significant movement of the implant postoperatively
- Range of motion (ROM) at each annual timepoint compared to baseline [10 years]
Changes of >3 mm will be considered significant due to the margin of error in radiographic determination of displacement distances.
- Rate of adverse events attributable to Simplify Disc, or use of additional NuVasive instruments, implants, or technologies at each annual timepoint [10 years]
Number of adverse events related to Simplify Disc or additional NuVasive products
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject was enrolled in the Simplify Disc post approval study (NCT04630626) at a participating study site
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Subject understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study
Exclusion Criteria:
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Subject had an SSI at the index level during the post approval study (NCT04630626)
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Subject was withdrawn or withdrew consent to participate in the post approval study (NCT04630626)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NorthShore University Health System | Evanston | Illinois | United States | 60201 |
| 2 | Indiana Spine Group | Carmel | Indiana | United States | 46032 |
| 3 | Spine Institute of Louisiana | Shreveport | Louisiana | United States | 71101 |
| 4 | Carolina Neurosurgery and Spine Associates | Charlotte | North Carolina | United States | 28204 |
| 5 | Texas Spine Consultants | Addison | Texas | United States | 75001 |
| 6 | Texas Back Institute | Plano | Texas | United States | 75093 |
Sponsors and Collaborators
- NuVasive
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NUVA.TDR0921