Post Approval Study Protocol for the Two Level Simplify® Cervical Artificial Disc

Completed

Conditions: Cervical Degenerative Disc Disorder

Registration Number: NCT04980378

Lead Sponsor: NuVasive

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 291

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Subjects who were withdrawn or withdrew consent to participate in the IDE study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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Composite Success	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	Individual success for Simplify Disc was defined as follows: * Neck Disability Index (NDI) score improvement of at least 15 points from pre-operative; * Maintenance or improvement in neurological status; * No serious adverse event classified as implant associated or implant/surgical procedure associated; and * No additional surgical procedure classified as a "failure."

Secondary Outcome Measures

Name	Time	Method
Clinically Significant Improvement in One or More Radicular Symptoms or Myelopathy	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	An arm pain questionnaire was used to measure radicular symptoms and compare to baseline symptoms in the IDE study. Changes of at least 2 points on a 10-point scale were regarded as clinically significant (0=no pain; 10=worst pain)
Health Survey; 36-Item Short Form Survey (SF-36) - Physical Component Score (PCS) Maintenance or Improvement	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	The PCS is a sub-score of the SF-36. The SF-36 is a multipurpose survey with 36 questions. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related quality-of-life. Higher scores indicate better outcomes. Scores range from 0-50. Maintenance or improvement was defined as PCS(Postop) - PCS(Preop) ≥0.
Health Survey; 36-Item Short Form Survey (SF-36) - Mental Component Score (MCS) Maintenance or Improvement	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	The MCS is a sub-score of the SF-36. The SF-36 is a multipurpose survey with 36 questions. The questions were combined, scored, and weighted to create two scores that provide glimpses into mental and physical functioning and overall health-related quality-of-life. Higher scores indicate better outcomes. Scores range from 0-50. Maintenance or improvement was defined as PCS(Postop) - PCS(Preop) ≥0.
Dysphagia Handicap Index (DHI Scale)	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.	Dysphagia Handicap Index score for the Simplify Disc subjects at 60 months. A higher score is indicative of a less desirable outcome. It is scored 0-100. Data was not collected on DHI in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
Patient Satisfaction	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	Patient satisfaction was assessed by survey based on the response to the statement "I am satisfied with the results of my surgery" at 60 months. Answer options ranged from definitely true to definitely false.
Physician's Perception	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	Results at 60 months were categorized by the physician's perception of the subject's condition (excellent, good, fair, or poor).
Change in Average Disc Height (Superior Index Level)	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.	Average disc height (superior index level) at 60 months was compared to the baseline measurement in the IDE study and the change was calculated. Measurements were scored by an independent core lab. Average disc height was calculated as the simple average of the anterior and posterior disc heights. Data was not collected on average disc height in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
Change in Average Disc Height (Inferior Index Level)	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.	Average disc height (inferior index level) at 60 months was compared to the baseline measurement in the IDE study and the change was calculated. Measurements were scored by an independent core lab. Average disc height was calculated as the simple average of the anterior and posterior disc heights. Data was not collected on average disc height in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
Adjacent Level Deterioration - Superior Adjacent Level	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.	Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) above the index level based on X-ray images. Degeneration was graded as none (no degenerative changes), doubtful (Minimal osteophytosis only), minimal (Definite osteophytosis with some sclerosis of anterior part of vertebral plates), moderate (Marked osteophytosis and sclerosis of vertebral plates with slight narrowing of disk space), or severe (Large osteophytes, marked sclerosis of vertebral plates, and marked narrowing of disk space). Assessments were made by an independent core lab. Data was not collected on adjacent level deterioration in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
Adjacent Level Deterioration - Inferior Adjacent Level	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.	Outcome reports the number and percentage of subjects with adjacent level disc degeneration (ALDD) below the index level based on X-ray images. Degeneration was graded as none (no degenerative changes), doubtful (Minimal osteophytosis only), minimal (Definite osteophytosis with some sclerosis of anterior part of vertebral plates), moderate (Marked osteophytosis and sclerosis of vertebral plates with slight narrowing of disk space), or severe (Large osteophytes, marked sclerosis of vertebral plates, and marked narrowing of disk space). Assessments were made by an independent core lab. Data was not collected on adjacent level deterioration in the historical ACDF control group. Only Simplify Disc subjects are reported. This was pre-specified in the study design.
Displacement or Migration of the Device	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	Displacement or migration of the device at 60 months was be compared to immediate post-op data collected in the IDE study. This was be graded by the radiographic core lab. Migration was considered "present" if changes of \>3mm were noted. The superior index level and inferior index level was assessed separately.

Trial Locations

Locations (18): Orthopaedic Education and Research Institute of Southern California
🇺🇸
Orange, California, United States
The Spine Institute for Spine Restoration
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Santa Monica, California, United States
Spine Education and Research Foundation
🇺🇸
Thornton, Colorado, United States
Connecticut Orthopaedic Specialists
🇺🇸
Hamden, Connecticut, United States
Kennedy-White Orthopedic Center
🇺🇸
Sarasota, Florida, United States
NorthShore University Health System
🇺🇸
Evanston, Illinois, United States
Indiana Spine Group
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Carmel, Indiana, United States
Parkview Research Center
🇺🇸
Fort Wayne, Indiana, United States
Orthopaedic Institute of Western Kentucky
🇺🇸
Paducah, Kentucky, United States
Spine Institute of Louisiana
🇺🇸
Shreveport, Louisiana, United States
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Orthopaedic Education and Research Institute of Southern California
🇺🇸Orange, California, United States