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

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).

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): 131

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92686
      • Hoag Orthopedics
    • Santa Monica, California, United States, 90403
      • The Spine Institute for Spine Restoration
  • Colorado
    • Thornton, Colorado, United States, 80229
      • Spine Education and Research
  • Florida
    • Sarasota, Florida, United States, 34232
      • Kennedy-White Orthopaedic Center
  • Illinois
    • Evanston, Illinois, United States, 60201
      • NorthShore University Health System
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Indiana Spine Group
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Spine Institute of Louisiana
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolina Neurosurgery and Spine Associates
  • Texas
    • Addison, Texas, United States, 75001
      • Texas Spine Consultants
    • Plano, Texas, United States, 75093
      • Texas Back Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes subjects treated with the NuVasive Simplify Disc in IDE study (NCT02667067) and followed in the PAS (NCT04630626).

Description

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 Subject was withdrawn or withdrew consent to participate in the post approval study (NCT04630626)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

How is the study designed?

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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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 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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: NuVasive

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2022
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): 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.TDR0921

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