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

NCT05691231 | Enrolling By Invitation FDA Device

• 1 other identifier: NUVA.TDR1022
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 2

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 at two levels in subjects who were enrolled in the IDE study (NCT03123549) and/or post approval study (NCT04980378).

Conditions

Cervical Disc Disease; Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Percentage of subjects meeting the minimal clinically important difference (MCID) for NDI at each annual timepoint

  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.

  10 years

• Motor status at each annual timepoint compared to baseline

  10 years

• Sensory status at each annual timepoint compared to baseline

  10 years

• SF-36® Health Survey at each annual timepoint compared to baseline

  10 years

Study Arms (1)

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

Interventions

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.

Simplify Disc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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• Subject was withdrawn or withdrew consent to participate in the IDE study (NCT03123549) or PAS (NCT04980378)

Sponsors & Collaborators

• NuVasive: lead

Study Sites (2)

Carolina Neurosurgery and Spine Associates

Charlotte, North Carolina, 28204, United States

Location

Texas Back Institute

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Kyle Malone

  NuVasive

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 19, 2023
• Study Start: January 18, 2023
• Primary Completion (Estimated): February 10, 2029
• Study Completion (Estimated): May 10, 2029
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)