Degenerative Disc Disease Clinical Trial
Official title:
Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc
Verified date | November 2023 |
Source | NuVasive |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Enrolling by invitation |
Enrollment | 131 |
Est. completion date | April 2028 |
Est. primary completion date | April 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. Subject was enrolled in the Simplify Disc post approval study (NCT04630626) at a participating study site 2. Subject understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study Exclusion Criteria: 1. Subject had an SSI at the index level during the post approval study (NCT04630626) 2. Subject was withdrawn or withdrew consent to participate in the post approval study (NCT04630626) |
Country | Name | City | State |
---|---|---|---|
United States | Texas Spine Consultants | Addison | Texas |
United States | Indiana Spine Group | Carmel | Indiana |
United States | Carolina Neurosurgery and Spine Associates | Charlotte | North Carolina |
United States | NorthShore University Health System | Evanston | Illinois |
United States | Hoag Orthopedics | Orange | California |
United States | Texas Back Institute | Plano | Texas |
United States | The Spine Institute for Spine Restoration | Santa Monica | California |
United States | Kennedy-White Orthopaedic Center | Sarasota | Florida |
United States | Spine Institute of Louisiana | Shreveport | Louisiana |
United States | Spine Education and Research | Thornton | Colorado |
Lead Sponsor | Collaborator |
---|---|
NuVasive |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Composite Success | 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. |
10 years | |
Secondary | 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 | |
Secondary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Treatment satisfaction questionnaire at each annual timepoint | Responses range from very dissatisfied to very satisfied | 10 years | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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