Clinical trial NCT04980378: Post Approval Study Protocol for the Two Level Simplify® Cervical Artificial Disc
Official title: Post Approval Study Protocol for the Two Level Simplify® Cervical Artificial Disc
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Degenerative Disc Disorder
Keywords: Two Level
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2021-07-28
Enrollment: 291
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include subjects who were enrolled in the IDE study G150206. This will include up to 170 subjects eligible for study enrollment from sixteen (16) sites in the two level Simplify Disc IDE study who consent to long-term follow-up. Additionally, up to 17 training subjects from the two level Simplify Disc IDE study from seventeen (17) sites will be enrolled.

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 two-level Simplify Disc Investigational Device Exemption (IDE) study. This study was conducted under IDE G150206


Eligibility criteria: Inclusion Criteria:

- All subjects enrolled in the two level 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* Subjects who were withdrawn or withdrew consent to participate in the IDE study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: Clinical Composite Success
timeFrame: Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported
Secondary outcomes:
measure: Clinically Significant Improvement in One or More Radicular Symptoms or Myelopathy
timeFrame: Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported
measure: Health Survey; 36-Item Short Form Survey (SF-36) - Physical Component Score (PCS) Maintenance or Improvement
timeFrame: Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported
measure: Health Survey; 36-Item Short Form Survey (SF-36) - Mental Component Score (MCS) Maintenance or Improvement
timeFrame: Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported
measure: Dysphagia Handicap Index (DHI Scale)
timeFrame: Data through 24 months gathered in IDE (NCT03123549 with start date of 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-operative.
measure: Patient Satisfaction
timeFrame: Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported
measure: Physician's Perception
timeFrame: Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported
measure: Change in Average Disc Height (Superior Index Level)
timeFrame: Data through 24 months gathered in IDE (NCT03123549 with start date of 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-operative.
measure: Change in Average Disc Height (Inferior Index Level)
timeFrame: Data through 24 months gathered in IDE (NCT03123549 with start date of 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-operative.
measure: Adjacent Level Deterioration - Superior Adjacent Level
timeFrame: Data through 24 months gathered in IDE (NCT03123549 with start date of 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-operative.
measure: Adjacent Level Deterioration - Inferior Adjacent Level
timeFrame: Data through 24 months gathered in IDE (NCT03123549 with start date of 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-operative.
measure: Displacement or Migration of the Device
timeFrame: Data through 24 months gathered in IDE (NCT03123549; start date 4/1/17). This PAS (start date 8/1/21) followed the same patient cohort through 60 months post-op. Comparison data from historical controls up to 60 months post-op is also reported
Other outcomes:
Locations:
city: Orange
country: United States
facility: Orthopaedic Education and Research Institute of Southern California
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: Hamden
country: United States
facility: Connecticut Orthopaedic Specialists
state: Connecticut
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: Fort Wayne
country: United States
facility: Parkview Research Center
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: Royal Oak
country: United States
facility: William Beaumont Hospital Research Institute
state: Michigan
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: Springfield
country: United States
facility: Oregon Neurosurgery
state: Oregon
city: Addison
country: United States
facility: Texas Spine Consultants
state: Texas
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
city: West Jordan
country: United States
facility: The Disc Replacement Center
state: Utah
city: Reston
country: United States
facility: Virginia Spine Institute
state: Virginia
Study officials:
affiliation: Globus Medical
name: Kyle Malone
role: STUDY_DIRECTOR
References: