Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels

Degenerative Disc Disease Clinical Trial

Official title:

Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05691231
• Other study ID #: NUVA.TDR1022
• Status: Enrolling by invitation
• Start date: January 18, 2023
• Est. completion date: May 10, 2029

Study information

• Verified date: November 2023
• Source: NuVasive
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 158
• Est. completion date: May 10, 2029
• Est. primary completion date: February 10, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Subject was withdrawn or withdrew consent to participate in the IDE study (NCT03123549) or PAS (NCT04980378)

Related Conditions & MeSH terms

• Cervical Disc Disease
• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spinal Diseases

Intervention

Device:
• NuVasive Simplify Cervical Artificial Disc
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.

Locations

Country	Name	City	State
United States	Carolina Neurosurgery and Spine Associates	Charlotte	North Carolina
United States	Texas Back Institute	Plano	Texas

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 Rate	Individual success is defined as at least a 15 point improvement in Neck Disability Index (NDI) Score at 120 months compared with baseline, maintenance or improvement in neurologic status at 120 months compared with baseline, no additional surgical procedure at the index level within 120 months, and the absence of a serious adverse event classified as implant-associated or implant/surgical procedure-associated within 120 months. A subject must meet each criterion to be considered an overall study success.; NDI scale is reported in a range from 0 - 100, with 0 consistent with best ability to function and 100 with worst ability to function.	10 years
Secondary	Percentage of subjects meeting the minimal clinically important difference (MCID) for NDI at each annual timepoint	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.	10 years
Secondary	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.	Neck and arm pain questionnaire, scale is reported in a range from 0 to 10, with 0 consistent with no pain and 10 with most pain	10 years
Secondary	Motor status at each annual timepoint compared to baseline	A change of one or more grade levels in muscle strength will be regarded as clinically significant.	10 years
Secondary	Sensory status at each annual timepoint compared to baseline	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.	10 years
Secondary	SF-36® Health Survey at each annual timepoint compared to baseline	The SF-36 is a multipurpose survey with 36 questions. 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 0-100.	10 years
Secondary	Dysphagia Handicap Index1 (DHI) at each annual timepoint compared to baseline	DHI is scored from 0-100, with a higher score indicative of a less desirable outcome.	10 years
Secondary	Disc height at each annual timepoint will be compared to baseline	Average disc height is calculated as the simple average of the anterior and posterior disc heights	10 years
Secondary	Adjacent level disc degeneration (ALDD) at each annual timepoint will be compared to baseline	ALDD is graded in accordance with definitions adapted from Kellgren and Lawrence: None; Doutbtful;Minimal;Moderate;Severe	10 years
Secondary	Displacement or migration of the Simplify Disc at each annual timepoint will be compared to the post-op timepoint in the IDE study (NCT03123549)	Device migration assesses significant movement of the implant postoperatively. Changes of >3 mm will be considered significant due to the margin of error in radiographic determination of displacement distances.	10 years
Secondary	Range of motion (ROM) at each annual timepoint compared to baseline	Changes in Global Range of Motion will be calculated by subtracting the range of motion measured at one time point from the baseline range of motion. Change in Global Range of Motion will be reported in units of degrees.	10 years
Secondary	Rate of adverse events attributable to Simplify Disc, or use of additional NuVasive instruments, implants, or technologies at each annual timepoint	Number of adverse events related to Simplify Disc or additional NuVasive products	10 years
Secondary	Patient satisfaction and perceived effect at each annual timepoint	Patient questionnaire assessing satisfaction with treatment and perceived effect of treatment. Success for each satisfaction question will be defined as either a "Definitely True" or "Mostly True" response. Success for the perceived effect question will be defined as either a "Completely Recovered," "Much Improved," or "Slightly Improved" response.	10 years