Clinical trial NCT05691231: Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels
Official title: Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cervical Disc Disease
Degenerative Disc Disease
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2023-01-19
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes subjects treated with the NuVasive Two Level Simplify Disc in IDE study (NCT03123549) and followed in the PAS (NCT04980378).

Brief summary: A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc at two levels in subjects who were enrolled in the IDE study (NCT03123549) and/or post approval study (NCT04980378).


Eligibility criteria: Inclusion Criteria:

1. Subject was enrolled in the Simplify Disc IDE (NCT03123549) and/or PAS (NCT04980378) at a participating study site
2. Patient understands the conditions of enrollment and is willing sign an informed consent form to participate in the study

Exclusion Criteria:

1. Subject had an SSI at the index level during the IDE study (NCT03123549) or the PAS (NCT04980378)
2. Subject was withdrawn or withdrew consent to participate in the IDE study (NCT03123549) or PAS (NCT04980378)

Primary outcomes:
measure: Clinical Composite Success Rate
timeFrame: 10 years
Secondary outcomes:
measure: Percentage of subjects meeting the minimal clinically important difference (MCID) for NDI at each annual timepoint
timeFrame: 10 years
measure: Percentage of subjects meeting MCID for neck and arm pain questionnaire for each of the following pain locations: neck pain, arm pain, left arm pain, right arm pain.
timeFrame: 10 years
measure: Motor status at each annual timepoint compared to baseline
timeFrame: 10 years
measure: Sensory status at each annual timepoint compared to baseline
timeFrame: 10 years
measure: SF-36® Health Survey at each annual timepoint compared to baseline
timeFrame: 10 years
measure: Dysphagia Handicap Index1 (DHI) at each annual timepoint compared to baseline
timeFrame: 10 years
measure: Disc height at each annual timepoint will be compared to baseline
timeFrame: 10 years
measure: Adjacent level disc degeneration (ALDD) at each annual timepoint will be compared to baseline
timeFrame: 10 years
measure: Displacement or migration of the Simplify Disc at each annual timepoint will be compared to the post-op timepoint in the IDE study (NCT03123549)
timeFrame: 10 years
measure: Range of motion (ROM) at each annual timepoint compared to baseline
timeFrame: 10 years
measure: Rate of adverse events attributable to Simplify Disc, or use of additional NuVasive instruments, implants, or technologies at each annual timepoint
timeFrame: 10 years
measure: Patient satisfaction and perceived effect at each annual timepoint
timeFrame: 10 years
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolina Neurosurgery and Spine Associates
state: North Carolina
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
Study officials:
affiliation: NuVasive
name: Kyle Malone
role: STUDY_DIRECTOR
References: