Active, Not Recruiting

NCT Number: NCT05258435

Long-term Assessment of the Safety and Performance of the NuVasive Simplify Disc

A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc in subjects who were enrolled in the post approval study (NCT04630626).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cervical Disc Disease Bone Diseases Degenerative Disc Disease Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hoag Orthopedics, Orange, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject was enrolled in the Simplify Disc post approval study (NCT04630626) at a participating study site
Subject understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study

Exclusion criteria

Subject had an SSI at the index level during the post approval study (NCT04630626)
Subject was withdrawn or withdrew consent to participate in the post approval study (NCT04630626)

Treatment and study plan

NuVasive Simplify Cervical Artificial Disc

Device

Simplify Disc is a weight-bearing cervical artificial disc implant consisting of PEEK (polyetheretherketone) endplates and one semi-constrained, fully articulating, mobile Zirconia Toughened Alumina ceramic (ZTA) core.

Primary outcomes

Clinical Composite Success

Time frame: 10 years
Individual patient success for the primary endpoint will be assessed at 120 months and is defined as follows:
- Improvement on the Neck Disability Index (NDI) of at least 15 percentage points compared to baseline (pre-op), and
- No device failures by month 120, and
- No secondary surgical intervention (SSI) at the index level (i.e., revision, removal, reoperation, or supplemental fixation) by month 120.

Secondary outcomes

Percentage of subjects meeting the minimal clinically important difference (MCID) for NDI at each annual timepoint

Time frame: 10 years

Neck Disability Index; scale is reported in a range from 0-100, with 0 consistent with best ability to function and 100 worst ability to function.
Percentage of subjects meeting MCID for Visual Analog Scale (VAS) for each of the following pain locations and each annual timepoint: neck and arm pain, neck only pain, left arm pain, and right arm pain

Time frame: 10 years

Visual Analog Scale, scale is reported in a range from 0 to 100, with 0 consistent with no pain and 100 with most pain
Motor status at each annual timepoint compared to baseline

Time frame: 10 years

A change of one or more grade levels in muscle strength will be regarded as clinically significant.
Sensory status at each annual timepoint compared to baseline

Time frame: 10 years

Sensation will be graded as normal or abnormal (diminished or absent). Any changes from abnormal to normal or absent to diminished will be regarded as clinically significant improvement.
Treatment satisfaction questionnaire at each annual timepoint

Time frame: 10 years

Responses range from very dissatisfied to very satisfied
SF-12v2® Health Survey at each annual timepoint compared to baseline

Time frame: 10 years

The SF-12 is a multipurpose short form survey with 12 questions selected from the SF-36 Health Survey. The questions were combined, scored and weighted to create mental and physical functioning and overall health-related quality of life. Higher scores indicate better outcomes. Scores range from 0-15.
Dysphagia Handicap Index1 (DHI) at each annual timepoint compared to baseline

Time frame: 10 years

DHI is scored from 0-100, with a higher score indicative of a less desirable outcome.
Disc height at each annual timepoint will be compared to baseline

Time frame: 10 years

Average disc height is calculated as the simple average of the anterior and posterior disc heights
Adjacent level disc degeneration (ALDD) at each annual timepoint will be compared to baseline

Time frame: 10 years

ALDD is graded in accordance with definitions adapted from Kellgren and Lawrence: None; Doutbtful;Minimal;Moderate;Severe
Displacement or migration of the Simplify Disc at each annual timepoint will be compared to the post-op timepoint in the IDE study (NCT02667067)

Time frame: 10 years

Device migration assesses significant movement of the implant postoperatively
Range of motion (ROM) at each annual timepoint compared to baseline

Time frame: 10 years

Changes of >3 mm will be considered significant due to the margin of error in radiographic determination of displacement distances.
Rate of adverse events attributable to Simplify Disc, or use of additional NuVasive instruments, implants, or technologies at each annual timepoint

Time frame: 10 years

Number of adverse events related to Simplify Disc or additional NuVasive products

Sponsors and collaborators

Lead sponsor

NuVasive

Industry

Registry information

Important dates

Study start: 2022
Primary completion: 2028
Study completion: 2028
First posted: Feb 28, 2022
Registry last updated: Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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