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

NCT ID: NCT05691231

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

158 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-18

Study Completion Date

2029-05-10

Brief Summary

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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).

Detailed Description

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Conditions

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Cervical Disc Disease Degenerative Disc Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Simplify Disc

Extended follow-up of subjects treated with the Simplify Disc during IDE study NCT03123549 and followed in the post-approval study NCT04980378.

NuVasive Simplify Cervical Artificial Disc

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NuVasive

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyle Malone

Role: STUDY_DIRECTOR

NuVasive

Locations

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Carolina Neurosurgery and Spine Associates

Charlotte, North Carolina, United States

Site Status

Texas Back Institute

Plano, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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NUVA.TDR1022

Identifier Type: -

Identifier Source: org_study_id