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

NuVasive

Status: Active, not recruiting

Conditions: Degenerative Disc Disease; Cervical Disc Disease

Treatments: Device: NuVasive Simplify Cervical Artificial Disc

Study type: Observational

Funder types: Industry

Identifiers

NCT05258435

NUVA.TDR0921

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 in subjects who were enrolled in the post approval study (NCT04630626).

Enrollment: 131 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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 Subject was withdrawn or withdrew consent to participate in the post approval study (NCT04630626)

Trial design

131 participants in 1 patient group

Simplify Disc

Description:

Extended follow-up of subjects treated with the Simplify Disc during IDE G140154 and followed in the post-approval study NCT04630626.

Treatment:

Device: NuVasive Simplify Cervical Artificial Disc