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

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05258435
• Other study ID #: NUVA.TDR0921
• Status: Enrolling by invitation
• Start date: February 9, 2022
• Est. completion date: April 2028

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 in subjects who were enrolled in the post approval study (NCT04630626).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 131
• Est. completion date: April 2028
• Est. primary completion date: April 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Subject was enrolled in the Simplify Disc post approval study (NCT04630626) at a participating study site

2. Subject understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study

Exclusion Criteria:

1. Subject had an SSI at the index level during the post approval study (NCT04630626)

2. Subject was withdrawn or withdrew consent to participate in the post approval study (NCT04630626)

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	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	Hoag Orthopedics	Orange	California
United States	Texas Back Institute	Plano	Texas
United States	The Spine Institute for Spine Restoration	Santa Monica	California
United States	Kennedy-White Orthopaedic Center	Sarasota	Florida
United States	Spine Institute of Louisiana	Shreveport	Louisiana
United States	Spine Education and Research	Thornton	Colorado

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 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.	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 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	Visual Analog Scale, scale is reported in a range from 0 to 100, with 0 consistent with no pain and 100 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	Treatment satisfaction questionnaire at each annual timepoint	Responses range from very dissatisfied to very satisfied	10 years
Secondary	SF-12v2® Health Survey at each annual timepoint compared to baseline	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.	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 (NCT02667067)	Device migration assesses significant movement of the implant postoperatively	10 years
Secondary	Range of motion (ROM) at each annual timepoint compared to baseline	Changes of >3 mm will be considered significant due to the margin of error in radiographic determination of displacement distances.	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