Post-Approval Study Protocol for the Simplify Cervical Artificial Disc

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04630626

Enrollment

145

Registered

2020-11-16

Start date

2021-01-01

Completion date

2023-04-23

Last updated

2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Degenerative Disc Disorder

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.

Interventions

DEVICESimplify Disc

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

OTHERACDF

Historical ACDF control data

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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study * Subjects who had a secondary surgical intervention at the index level during the IDE study * Subjects who were withdrawn or withdrew consent to participate in the IDE study * Subjects who do not consent to participate in long-term follow-up post-approval study

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Clinical Composite Success, Parent IDE Study + Post Approval Study (PAS)	IDE study 24 months + PAS 36 months = 60 months total	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.

Secondary

Measure	Time frame	Description
Clinical Improvement in One or More Radicular Symptoms or Myelopathy (Visual Analog Scale), Parent IDE Study + Post Approval Study (PAS)	IDE study 24 months + PAS 36 months = 60 months total	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).
Participants Average Disc Height, Parent IDE Study + Post Approval Study (PAS)	IDE study 24 months + PAS 36 months = 60 months total	Disc height is calculated as a simple average of the anterior and posterior disc heights of the treated index level.
Percentage of Participants With No Adjacent Level Disc Deterioration (ALDD) Superior Level, Parent IDE Study + Post Approval Study (PAS)	IDE study 24 months + PAS 36 months = 60 months total	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.
Percentage of Participants With No Adjacent Level Disc Deterioration (ALDD) Inferior Level, Parent IDE Study + Post Approval Study (PAS)	IDE study 24 months + PAS 36 months = 60 months total	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.
Number of Participants With Clinical Improvement in One or More Radicular Symptoms or Myelopathy (Neurological Status), Parent IDE Study + Post Approval Study (PAS)	IDE study 24 months + PAS 36 months = 60 months total	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.
Percentage of Participants Reporting Overall Treatment Satisfaction of Very Satisfied or Satisfied, Parent IDE Study + Post Approval Study (PAS)	IDE study 24 months + PAS 36 months = 60 months total	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.
Participants With Maintenance or Improvement on 12-Item Short Form Survey (SF-12), Parent IDE Study + Post Approval Study (PAS)	IDE study 24 months + PAS 36 months = 60 months total	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.
Percentage of Participants With No Dysphagia Handicap Index (DHI), Parent IDE Study + Post Approval Study (PAS)	IDE study 24 months + PAS 36 months = 60 months total	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.
Percentage of Participants With No Displacement or Migration of the Device, Parent IDE Study + Post Approval Study (PAS)	IDE study 24 months + PAS 36 months = 60 months total	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)

Countries

United States

Participant flow

Recruitment details

No recruitment - long term follow up of subjects previously enrolled in IDE and historical control data

Participants by arm

Arm	Count
Simplify Disc Extended follow-up of IDE Subjects treated with the Simplify Cervical Artificial Disc during IDE G140154 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.	142
Historical ACDF Control Historical ACDF Data from similar protocol used as control. ACDF: Historical ACDF control data	106
Total	248

Baseline characteristics

Characteristic	Simplify Disc	Historical ACDF Control	Total
Age, Continuous	43.2 years	43.9 years	43.6 years
Race/Ethnicity, Customized Black	10 Participants	7 Participants	17 Participants
Race/Ethnicity, Customized Caucasian	123 Participants	93 Participants	216 Participants
Race/Ethnicity, Customized Hispanic	4 Participants	5 Participants	9 Participants
Race/Ethnicity, Customized Other	5 Participants	1 Participants	6 Participants
Region of Enrollment United States	142 Participants	106 Participants	248 Participants
Sex: Female, Male Female	89 Participants	63 Participants	152 Participants
Sex: Female, Male Male	53 Participants	43 Participants	96 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 132	0 / 106
other Total, other adverse events	105 / 132	72 / 106
serious Total, serious adverse events	25 / 132	17 / 106

Outcome results

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.