We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post-Approval Study Protocol for the Simplify Cervical Artificial Disc

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04630626
Recruitment Status : Active, not recruiting
First Posted : November 16, 2020
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
Simplify Medical Inc.

Tracking Information
First Submitted Date November 9, 2020
First Posted Date November 16, 2020
Last Update Posted Date March 16, 2021
Actual Study Start Date January 1, 2021
Estimated Primary Completion Date March 23, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 13, 2020)
Clinical Composite Success [ Time Frame: 60 Months ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 13, 2020)
  • Clinical Improvement in one or more radicular symptoms or myelopathy (neurological status) [ Time Frame: 60 Months ]
    Endpoint will be examined using Neurological Status (motor exam, sensory exam, gait exam, and reflexes) at each visit compared to baseline from the IDE
  • Clinical Improvement in one or more radicular symptoms or myelopathy (Visual Analog Scale) [ Time Frame: 60 Months ]
    Endpoint will be examined using the Visual Analog Scale (VAS) which is a straight horizontal line of fixed length (100 millimeters) oriented from the left (best) to the right (worst)
  • Disc Height [ Time Frame: 60 Months ]
    Disc height will be compared to baseline from the IDE
  • Adjacent level Deterioration [ Time Frame: 60 Months ]
    Adjacent level Deterioration will be compared to baseline from the IDE
  • Displacement or Migration of the device [ Time Frame: 60 Months ]
    Displacement or Migration of the device will be compared to baseline from the IDE (changes of >3 mm will be considered significant)
  • Treatment Satisfaction [ Time Frame: 60 Months ]
    Treatment satisfaction will be examined at 60 months. This will be collected via a questionnaire, completed by the subject, that will ask questions regarding overall satisfaction with treatment, relief from symptoms, exercise, and activity levels.
  • 12-Item Short Form Survey (SF-12) [ Time Frame: 60 Months ]
    12-Item Short Form Survey (SF-12) will be compared to baseline from the IDE
  • Dysphagia Handicap Index (DHI) [ Time Frame: 60 Months ]
    Dysphagia Handicap Index (DHI) will be compared to baseline from the IDE
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post-Approval Study Protocol for the Simplify Cervical Artificial Disc
Official Title Extended Follow-up of Investigational Device Exemption (IDE) Subjects Treated With the Simplify Cervical Artificial Disc
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 Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The population will include subjects that were previously enrolled in the Simplify Disc IDE study and meet the inclusion/exclusion criteria for this study.
Condition Cervical Degenerative Disc Disorder
Intervention Device: 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.
Study Groups/Cohorts Simplify Disc
Extended follow-up of IDE Subjects treated with the Simplify Cervical Artificial Disc during IDE G140154
Intervention: Device: Simplify Disc
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: November 13, 2020)
142
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 23, 2023
Estimated Primary Completion Date March 23, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04630626
Other Study ID Numbers P200022 PAS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Simplify Medical Inc.
Original Responsible Party Same as current
Current Study Sponsor Simplify Medical Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Simplify Medical Inc.
Verification Date March 2021