Clinical trial NCT04630626: Post-Approval Study Protocol for the Simplify Cervical Artificial Disc
Official title: Extended Follow-up of Investigational Device Exemption (IDE) Subjects Treated With the Simplify Cervical Artificial Disc
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Degenerative Disc Disorder
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2020-11-16
Enrollment: 145
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is intended to demonstrate the 5-year long-term safety and efficacy of the Simplify® Cervical Artificial Disc ("Simplify Disc") in subjects enrolled in the non-randomized Simplify Disc IDE study. This study was conducted under IDE G140154.

Detailed description: This post approval study (PAS) is a continuation of the IDE pivotal study (G140154) as required under P200022. These data include long-term follow-up of subjects enrolled and treated under the IDE study from February 2016 to 2018 out to 60 months post-op. The control group is comprised of a historical ACDF population. Subjects were enrolled (signed consent) into the PAS on a rolling basis at either the 36 month, 48 month or 60 month visit based on their treatment date (under IDE G140154) and the date of PAS protocol approval. Data presented are compared to baseline data collected as part of the IDE study. Therefore, the start date and end dates of the PAS are not inclusive of the full 60 months of reported data.

Eligibility criteria: Inclusion Criteria:

- All subjects enrolled in the Simplify Disc IDE study are considered for this long-term follow-up study.

Exclusion Criteria:

* Subjects who were not implanted with the Simplify Disc during the IDE study
* Subjects who had a secondary surgical intervention at the index level during the IDE study
* Subjects who were withdrawn or withdrew consent to participate in the IDE study
* Subjects who do not consent to participate in long-term follow-up post-approval study

Primary outcomes:
measure: Number of Participants With Clinical Composite Success, Parent IDE Study + Post Approval Study (PAS)
timeFrame: IDE study 24 months + PAS 36 months = 60 months total
Secondary outcomes:
measure: Number of Participants With Clinical Improvement in One or More Radicular Symptoms or Myelopathy (Neurological Status), Parent IDE Study + Post Approval Study (PAS)
timeFrame: IDE study 24 months + PAS 36 months = 60 months total
measure: Clinical Improvement in One or More Radicular Symptoms or Myelopathy (Visual Analog Scale), Parent IDE Study + Post Approval Study (PAS)
timeFrame: IDE study 24 months + PAS 36 months = 60 months total
measure: Participants Average Disc Height, Parent IDE Study + Post Approval Study (PAS)
timeFrame: IDE study 24 months + PAS 36 months = 60 months total
measure: Percentage of Participants With No Adjacent Level Disc Deterioration (ALDD) Superior Level, Parent IDE Study + Post Approval Study (PAS)
timeFrame: IDE study 24 months + PAS 36 months = 60 months total
measure: Percentage of Participants With No Adjacent Level Disc Deterioration (ALDD) Inferior Level, Parent IDE Study + Post Approval Study (PAS)
timeFrame: IDE study 24 months + PAS 36 months = 60 months total
measure: Percentage of Participants With No Displacement or Migration of the Device, Parent IDE Study + Post Approval Study (PAS)
timeFrame: IDE study 24 months + PAS 36 months = 60 months total
measure: Percentage of Participants Reporting Overall Treatment Satisfaction of "Very Satisfied" or "Satisfied", Parent IDE Study + Post Approval Study (PAS)
timeFrame: IDE study 24 months + PAS 36 months = 60 months total
measure: Participants With Maintenance or Improvement on 12-Item Short Form Survey (SF-12), Parent IDE Study + Post Approval Study (PAS)
timeFrame: IDE study 24 months + PAS 36 months = 60 months total
measure: Percentage of Participants With No Dysphagia Handicap Index (DHI), Parent IDE Study + Post Approval Study (PAS)
timeFrame: IDE study 24 months + PAS 36 months = 60 months total
Other outcomes:
Locations:
city: Orange
country: United States
facility: Orthopaedic Education and Research Institute of Southern California
state: California
city: San Diego
country: United States
facility: USCD
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 Foundation
state: Colorado
city: Sarasota
country: United States
facility: Kennedy-White orthopedic 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: Paducah
country: United States
facility: Orthopaedic Institute of Western Kentucky
state: Kentucky
city: Shreveport
country: United States
facility: Spine institute of Louisiana
state: Louisiana
city: Egg Harbor Township
country: United States
facility: Rothman Institute
state: New Jersey
city: Lockport
country: United States
facility: Buffalo Spine Surgery
state: New York
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
city: Reston
country: United States
facility: Virginia Spine Institute
state: Virginia
Study officials:
References: