Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc

• Conditions: Degenerative Disc Disease; Cervical Disc Disease
• Interventions: Device: NuVasive Simplify Cervical Artificial Disc

• Registration Number: NCT05258435
• Lead Sponsor: NuVasive

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-08
• Study Start: 2022-02-09
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09
• Primary Completion: 2028-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 131

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 Subject was withdrawn or withdrew consent to participate in the post approval study (NCT04630626)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Simplify Disc	NuVasive Simplify Cervical Artificial Disc	Extended follow-up of subjects treated with the Simplify Disc during IDE G140154 and followed in the post-approval study NCT04630626.

Primary Outcome Measures

Name	Time	Method
Clinical Composite Success	10 years	Individual patient success for the primary endpoint will be assessed at 120 months and is defined as follows: 1. Improvement on the Neck Disability Index (NDI) of at least 15 percentage points compared to baseline (pre-op), and; 2. No device failures by month 120, and; 3. No secondary surgical intervention (SSI) at the index level (i.e., revision, removal, reoperation, or supplemental fixation) by month 120.

Secondary Outcome Measures

Name	Time	Method
Treatment satisfaction questionnaire at each annual timepoint	10 years	Responses range from very dissatisfied to very satisfied
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.
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
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.
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.
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
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
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.
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
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
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.
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.

Trial Locations

Locations (10)

Carolina Neurosurgery and Spine Associates; 🇺🇸 Charlotte, North Carolina, United States

Texas Spine Consultants; 🇺🇸 Addison, Texas, United States

Spine Education and Research; 🇺🇸 Thornton, Colorado, United States

The Spine Institute for Spine Restoration; 🇺🇸 Santa Monica, California, United States

Spine Institute of Louisiana; 🇺🇸 Shreveport, Louisiana, United States

Texas Back Institute; 🇺🇸 Plano, Texas, United States

NorthShore University Health System; 🇺🇸 Evanston, Illinois, United States

Kennedy-White Orthopaedic Center; 🇺🇸 Sarasota, Florida, United States

Indiana Spine Group; 🇺🇸 Carmel, Indiana, United States

Hoag Orthopedics; 🇺🇸 Orange, California, United States