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

Cervical Degenerative Disc Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04980378
• Other study ID #: P200022_S003_PAS
• Status: Completed
• Start date: August 1, 2021
• Est. completion date: January 24, 2024

Study information

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: January 24, 2024
• Est. primary completion date: January 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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• Subjects who were withdrawn or withdrew consent to participate in the IDE study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

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.

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	NorthShore University Health System	Evanston	Illinois
United States	Parkview Research Center	Fort Wayne	Indiana
United States	Connecticut Orthopaedic Specialists	Hamden	Connecticut
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	William Beaumont Hospital Research Institute	Royal Oak	Michigan
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	Oregon Neurosurgery	Springfield	Oregon
United States	Spine Education and Research Foundation	Thornton	Colorado
United States	The Disc Replacement Center	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
NuVasive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Composite Success	Individual success for Simplify Disc is 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."	60 Months
Secondary	Clinically significant improvement in one or more radicular symptoms or myelopathy	Clinically significant improvement in one or more radicular symptoms or myelopathy at each annual timepoint compared to baseline in the IDE study for the two level Simplify Disc. Endpoints will be graded based on pain questionnaires, motor status, and sensory status.	60 Months
Secondary	Time to recovery	Time to recovery defined as the earliest time at which a minimum 15-point (out of 100) NDI improvement is reached.	60 Months
Secondary	Disc Height	Disc height at each annual timepoint compared to baseline (6 weeks) in the IDE study for the two level Simplify Disc. Both levels had to be a disc height success to claim success for overall disc height. This will be graded by the radiographic core laboratory.	60 Months
Secondary	Adjacent Level Deterioration	Adjacent level deterioration at each annual timepoint compared to baseline in the investigational group of the IDE study for the two level Simplify Disc. This will be graded by the radiographic core laboratory.	60 Months
Secondary	Displacement or Migration of the Device	Displacement or migration of the device will be compared to baseline in the IDE. This will be graded by the radiographic core lab.	60 Months
Secondary	Work Status	Return to work status post-operatively. The subjects will be surveyed for this at each follow-up visit	60 Months
Secondary	Patient Satisfaction	Patient satisfaction and perceived effect at each annual timepoint. Success will be graded via a survey response of 'Definitely True' or 'Mostly True'	60 Months
Secondary	Health Survey; 36-Item Short Form Survey (SF-36)	Health Survey at each annual timepoint compared to baseline.	60 Months
Secondary	Dysphagia Handicap Index (DHI scale)	Dysphagia Handicap Index (DHI scale) for the Simplify Disc at 60 months compared to baseline in the two level IDE study.	60 Months
Secondary	Adjacent Level Motion (Stability)	Adjacent Level Motion (Stability) will be compared at 60 months to baseline. This will be graded by the radiographic core lab.	60 Months
Secondary	Physician's Perception	Results at 60 months will be categorized by the physician's perception of the subject's condition (excellent, good, fair, or poor).	60 Months
Secondary	Gait Assessment	Gait assessment at 60 months compared to baseline. This will be based on Nurick's classification. Success will be defined as maintenance or improvement in the post-operative status as compared to the pre-operative condition.	60 Months