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

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
NuVasive
Study ID
NCT05691231
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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).

Key Dates

Start date
Jan 18, 2023
Status verified
Dec 2025
Primary completion
Feb 10, 2029
Completion
May 10, 2029

Study Design

Enrollment
158 participants (estimated)

Arms

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

Primary Outcome Measure

Clinical Composite Success Rate [ Time Frame: 10 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Carolina Neurosurgery and Spine AssociatesCharlotteNorth Carolina28204-
Texas Back InstitutePlanoTexas75093-

Find similar trials in Charlotte, NC

By research site
Carolina Neurosurgery and Spine Associates· Charlotte, NCTexas Back Institute· Plano, TX

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