Post-Approval Study Protocol for the Simplify Cervical Artificial Disc

Cervical Degenerative Disc Disorder Clinical Trial

Official title:

Extended Follow-up of Investigational Device Exemption (IDE) Subjects Treated With the Simplify Cervical Artificial Disc

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04630626
• Other study ID #: P200022 PAS
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: April 23, 2023

Study information

• Verified date: May 2024
• Source: NuVasive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: April 23, 2023
• Est. primary completion date: April 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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• Subjects who were withdrawn or withdrew consent to participate in the IDE study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

Related Conditions & MeSH terms

• Cervical Degenerative Disc Disorder

Intervention

Device:
• Simplify Disc
The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core.

Other:
• ACDF
Historical ACDF control data

Locations

Country	Name	City	State
United States	Texas Spine Consultants	Addison	Texas
United States	Indiana Spine Group	Carmel	Indiana
United States	Carolina Neurosurgery and Spine Associates	Charlotte	North Carolina
United States	Rothman Institute	Egg Harbor Township	New Jersey
United States	NorthShore University Health System	Evanston	Illinois
United States	Buffalo Spine Surgery	Lockport	New York
United States	Orthopaedic Education and Research Institute of Southern California	Orange	California
United States	Orthopaedic Institute of Western Kentucky	Paducah	Kentucky
United States	Texas Back Institute	Plano	Texas
United States	Virginia Spine Institute	Reston	Virginia
United States	USCD	San Diego	California
United States	The Spine Institute for Spine Restoration	Santa Monica	California
United States	Kennedy-White orthopedic Center	Sarasota	Florida
United States	Spine institute of Louisiana	Shreveport	Louisiana
United States	Spine Education and Research Foundation	Thornton	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
NuVasive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Clinical Composite Success, Parent IDE Study + Post Approval Study (PAS)	Individual success for Simplify Disc and the historical control Anterior Cervical Discectomy and Fusion (ACDF) is defined as follows: Improvement on the Neck Disability Index (NDI) of at least 15 percentage points compared to baseline in the Simplify Disc IDE study, and; No device failures by Month 60, and; No subsequent surgical procedure at the index level (including revision, removal, reoperation, or supplemental fixation) by Month 60.	IDE study 24 months + PAS 36 months = 60 months total
Secondary	Number of Participants With Clinical Improvement in One or More Radicular Symptoms or Myelopathy (Neurological Status), Parent IDE Study + Post Approval Study (PAS)	Endpoint includes the number of participates in each group that had improvement in one or more radicular symptoms or myelopathy based on their Neurological Status (motor exam, sensory exam, gait exam, and reflexes) at 60 months when compared to baseline data from the prior IDE study.	IDE study 24 months + PAS 36 months = 60 months total
Secondary	Clinical Improvement in One or More Radicular Symptoms or Myelopathy (Visual Analog Scale), Parent IDE Study + Post Approval Study (PAS)	Endpoint was examined using the Visual Analog Scale (VAS) for neck and arm pain which is a straight horizontal line of fixed length (100 millimeters) oriented from zero or no pain (best) to 100mm or the worst pain ever (worst).	IDE study 24 months + PAS 36 months = 60 months total
Secondary	Participants Average Disc Height, Parent IDE Study + Post Approval Study (PAS)	Disc height is calculated as a simple average of the anterior and posterior disc heights of the treated index level.	IDE study 24 months + PAS 36 months = 60 months total
Secondary	Percentage of Participants With No Adjacent Level Disc Deterioration (ALDD) Superior Level, Parent IDE Study + Post Approval Study (PAS)	Adjacent level disc deterioration looks at the quality of the disc space above (superior) and below (inferior) the treated index level on available radiographic images and each is graded as None, Mild, Moderate, Severe.	IDE study 24 months + PAS 36 months = 60 months total
Secondary	Percentage of Participants With No Adjacent Level Disc Deterioration (ALDD) Inferior Level, Parent IDE Study + Post Approval Study (PAS)	Adjacent level disc deterioration looks at the quality of the disc space above (superior) and below (inferior) the treated index level on available radiographic images and each is graded as None, Mild, Moderate, Severe.	IDE study 24 months + PAS 36 months = 60 months total
Secondary	Percentage of Participants With No Displacement or Migration of the Device, Parent IDE Study + Post Approval Study (PAS)	Displacement or Migration of the device will be compared device placement at 60 months to immediate post-op data collected under the IDE study (changes of >3 mm will be considered significant)	IDE study 24 months + PAS 36 months = 60 months total
Secondary	Percentage of Participants Reporting Overall Treatment Satisfaction of "Very Satisfied" or "Satisfied", Parent IDE Study + Post Approval Study (PAS)	Overall Treatment satisfaction was examined at 60 months. This was collected via a questionnaire completed by the subject. Response options to "How does the subject rate satisfaction with the treatment received?" included "Very Satisfied", "Satisfied", "Somewhat Satisfied", "Somewhat Dissatisfied", and "Very Dissatisfied". Response options to "If you could go back in time, would you choose to have the same treatment that you received for your neck condition?" included "Definitely Yes", "Probably Yes", "Maybe", "Probably Not" and "Definitely Not".	IDE study 24 months + PAS 36 months = 60 months total
Secondary	Participants With Maintenance or Improvement on 12-Item Short Form Survey (SF-12), Parent IDE Study + Post Approval Study (PAS)	12-Item Short Form Survey (SF-12) is a questionnaire completed by the subject. Outcomes will be comparted at 60 months post treatment to baseline data collected from the IDE study.	IDE study 24 months + PAS 36 months = 60 months total
Secondary	Percentage of Participants With No Dysphagia Handicap Index (DHI), Parent IDE Study + Post Approval Study (PAS)	Dysphagia Handicap Index (DHI) is a questionnaire completed by the subject. Outcomes at 60 months post-op were compared to baseline data collected under the IDE study.	IDE study 24 months + PAS 36 months = 60 months total