Clinical trial NCT05258435: Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc
Official title: Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cervical Disc Disease
Degenerative Disc Disease
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2022-02-28
Enrollment: 131
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes subjects treated with the NuVasive Simplify Disc in IDE study (NCT02667067) and followed in the PAS (NCT04630626).

Brief summary: 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).


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 Subject was withdrawn or withdrew consent to participate in the post approval study (NCT04630626)

Primary outcomes:
measure: Clinical Composite Success
timeFrame: 10 years
Secondary outcomes:
measure: Percentage of subjects meeting the minimal clinically important difference (MCID) for NDI at each annual timepoint
timeFrame: 10 years
measure: Percentage of subjects meeting MCID for Visual Analog Scale (VAS) for each of the following pain locations and each annual timepoint: neck and arm pain, neck only pain, left arm pain, and right arm pain
timeFrame: 10 years
measure: Motor status at each annual timepoint compared to baseline
timeFrame: 10 years
measure: Sensory status at each annual timepoint compared to baseline
timeFrame: 10 years
measure: Treatment satisfaction questionnaire at each annual timepoint
timeFrame: 10 years
measure: SF-12v2® Health Survey at each annual timepoint compared to baseline
timeFrame: 10 years
measure: Dysphagia Handicap Index1 (DHI) at each annual timepoint compared to baseline
timeFrame: 10 years
measure: Disc height at each annual timepoint will be compared to baseline
timeFrame: 10 years
measure: Adjacent level disc degeneration (ALDD) at each annual timepoint will be compared to baseline
timeFrame: 10 years
measure: Displacement or migration of the Simplify Disc at each annual timepoint will be compared to the post-op timepoint in the IDE study (NCT02667067)
timeFrame: 10 years
measure: Range of motion (ROM) at each annual timepoint compared to baseline
timeFrame: 10 years
measure: Rate of adverse events attributable to Simplify Disc, or use of additional NuVasive instruments, implants, or technologies at each annual timepoint
timeFrame: 10 years
Other outcomes:
Locations:
city: Orange
country: United States
facility: Hoag Orthopedics
state: California
city: Santa Monica
country: United States
facility: The Spine Institute for Spine Restoration
state: California
city: Thornton
country: United States
facility: Spine Education and Research
state: Colorado
city: Sarasota
country: United States
facility: Kennedy-White Orthopaedic Center
state: Florida
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Charlotte
country: United States
facility: Carolina Neurosurgery and Spine Associates
state: North Carolina
city: Addison
country: United States
facility: Texas Spine Consultants
state: Texas
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
Study officials:
References: