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

NuVasive

Status: Invitation-only

Conditions: Degenerative Disc Disease; Cervical Disc Disease

Treatments: Device: NuVasive Simplify Cervical Artificial Disc

Study type: Observational

Funder types: Industry

Identifiers

NCT05691231

NUVA.TDR1022

Details and patient eligibility

About

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).

Enrollment: 158 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 Subject was withdrawn or withdrew consent to participate in the IDE study (NCT03123549) or PAS (NCT04980378)

Trial design

158 participants in 1 patient group

Simplify Disc

Description:

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

Treatment:

Device: NuVasive Simplify Cervical Artificial Disc