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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simplify Disc | Extended follow-up of subjects treated with the Simplify Disc during IDE G140154 and followed in the post-approval study NCT04630626. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NuVasive Simplify Cervical Artificial Disc | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Composite Success | Individual patient success for the primary endpoint will be assessed at 120 months and is defined as follows:
| 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects meeting the minimal clinically important difference (MCID) for NDI at each annual timepoint | 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. | 10 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes subjects treated with the NuVasive Simplify Disc in IDE study (NCT02667067) and followed in the PAS (NCT04630626).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoag Orthopedics | Orange | California | 92686 | United States | ||
| The Spine Institute for Spine Restoration |
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Visual Analog Scale, scale is reported in a range from 0 to 100, with 0 consistent with no pain and 100 with most pain |
| 10 years |
| Motor status at each annual timepoint compared to baseline | A change of one or more grade levels in muscle strength will be regarded as clinically significant. | 10 years |
| Sensory status at each annual timepoint compared to baseline | 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. | 10 years |
| Treatment satisfaction questionnaire at each annual timepoint | Responses range from very dissatisfied to very satisfied | 10 years |
| SF-12v2® Health Survey at each annual timepoint compared to baseline | 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. | 10 years |
| Dysphagia Handicap Index1 (DHI) at each annual timepoint compared to baseline | DHI is scored from 0-100, with a higher score indicative of a less desirable outcome. | 10 years |
| Disc height at each annual timepoint will be compared to baseline | Average disc height is calculated as the simple average of the anterior and posterior disc heights | 10 years |
| Adjacent level disc degeneration (ALDD) at each annual timepoint will be compared to baseline | ALDD is graded in accordance with definitions adapted from Kellgren and Lawrence: None; Doutbtful;Minimal;Moderate;Severe | 10 years |
| Displacement or migration of the Simplify Disc at each annual timepoint will be compared to the post-op timepoint in the IDE study (NCT02667067) | Device migration assesses significant movement of the implant postoperatively | 10 years |
| Range of motion (ROM) at each annual timepoint compared to baseline | Changes of >3 mm will be considered significant due to the margin of error in radiographic determination of displacement distances. | 10 years |
| Rate of adverse events attributable to Simplify Disc, or use of additional NuVasive instruments, implants, or technologies at each annual timepoint | Number of adverse events related to Simplify Disc or additional NuVasive products | 10 years |
| Santa Monica |
| California |
| 90403 |
| United States |
| Spine Education and Research | Thornton | Colorado | 80229 | United States |
| Kennedy-White Orthopaedic Center | Sarasota | Florida | 34232 | United States |
| NorthShore University Health System | Evanston | Illinois | 60201 | United States |
| Indiana Spine Group | Carmel | Indiana | 46032 | United States |
| Spine Institute of Louisiana | Shreveport | Louisiana | 71101 | United States |
| Carolina Neurosurgery and Spine Associates | Charlotte | North Carolina | 28204 | United States |
| Texas Spine Consultants | Addison | Texas | 75001 | United States |
| Texas Back Institute | Plano | Texas | 75093 | United States |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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