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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Subject was withdrawn or withdrew consent to participate in the IDE study (NCT03123549) or PAS (NCT04980378)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

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05691231
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

NuVasive
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kyle Malone
Principal Investigator Affiliation NuVasive
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cervical Disc Disease, Degenerative Disc Disease
Arms & Interventions

Arms

: Simplify Disc

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

Interventions

Device: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Charlotte, North Carolina

Status

Address

Carolina Neurosurgery and Spine Associates

Charlotte, North Carolina, 28204

Texas Back Institute, Plano, Texas

Status

Address

Texas Back Institute

Plano, Texas, 75093