Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels

A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc at two levels in subjects who were enrolled in the IDE study (NCT03123549) and/or post approval study (NCT04980378).

Study Overview

• Status: Enrolling by invitation
• Conditions: Degenerative Disc Disease; Cervical Disc Disease
• Intervention / Treatment: Device: NuVasive Simplify Cervical Artificial Disc

• Study Type: Observational
• Enrollment (Estimated): 158

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolina Neurosurgery and Spine Associates
  • Texas
    • Plano, Texas, United States, 75093
      • Texas Back Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes subjects treated with the NuVasive Two Level Simplify Disc in IDE study (NCT03123549) and followed in the PAS (NCT04980378).

Description

Inclusion Criteria:

1. Subject was enrolled in the Simplify Disc IDE (NCT03123549) and/or PAS (NCT04980378) at a participating study site
2. Patient understands the conditions of enrollment and is willing sign an informed consent form to participate in the study

Exclusion Criteria:

1. Subject had an SSI at the index level during the IDE study (NCT03123549) or the PAS (NCT04980378)
2. Subject was withdrawn or withdrew consent to participate in the IDE study (NCT03123549) or PAS (NCT04980378)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Simplify Disc; Extended follow-up of subjects treated with the Simplify Disc during IDE study NCT03123549 and followed in the post-approval study NCT04980378.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Composite Success Rate	Individual success is defined as at least a 15 point improvement in Neck Disability Index (NDI) Score at 120 months compared with baseline, maintenance or improvement in neurologic status at 120 months compared with baseline, no additional surgical procedure at the index level within 120 months, and the absence of a serious adverse event classified as implant-associated or implant/surgical procedure-associated within 120 months. A subject must meet each criterion to be considered an overall study success. NDI scale is reported in a range from 0 - 100, with 0 consistent with best ability to function and 100 with worst ability to function.	10 years

Secondary Outcome Measures

Outcome Measure	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 neck and arm pain questionnaire for each of the following pain locations: neck pain, arm pain, left arm pain, right arm pain.	Neck and arm pain questionnaire, scale is reported in a range from 0 to 10, with 0 consistent with no pain and 10 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
SF-36® Health Survey at each annual timepoint compared to baseline	The SF-36 is a multipurpose survey with 36 questions. 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 0-100.	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 (NCT03123549)	Device migration assesses significant movement of the implant postoperatively. Changes of >3 mm will be considered significant due to the margin of error in radiographic determination of displacement distances.	10 years
Range of motion (ROM) at each annual timepoint compared to baseline	Changes in Global Range of Motion will be calculated by subtracting the range of motion measured at one time point from the baseline range of motion. Change in Global Range of Motion will be reported in units of degrees.	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
Patient satisfaction and perceived effect at each annual timepoint	Patient questionnaire assessing satisfaction with treatment and perceived effect of treatment. Success for each satisfaction question will be defined as either a "Definitely True" or "Mostly True" response. Success for the perceived effect question will be defined as either a "Completely Recovered," "Much Improved," or "Slightly Improved" response.	10 years

Collaborators and Investigators

• Sponsor: NuVasive
• Investigators: Study Director: Kyle Malone, NuVasive

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2023
• Primary Completion (Estimated): February 10, 2029
• Study Completion (Estimated): May 10, 2029

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Intervertebral Disc Degeneration; Spinal Diseases
• Other Study ID Numbers: NUVA.TDR1022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No