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.

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.

Condition or disease Intervention/treatment
Cervical Degenerative Disc Disorder Device: Simplify Disc

Layout table for study information
Study Type : Observational
Estimated Enrollment : 142 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Extended Follow-up of Investigational Device Exemption (IDE) Subjects Treated With the Simplify Cervical Artificial Disc
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : March 23, 2023
Estimated Study Completion Date : June 23, 2023

Group/Cohort Intervention/treatment
Simplify Disc
Extended follow-up of IDE Subjects treated with the Simplify Cervical Artificial Disc during IDE G140154
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. Disc Height [ Time Frame: 60 Months ]
    Disc height will be compared to baseline from the IDE

  4. Adjacent level Deterioration [ Time Frame: 60 Months ]
    Adjacent level Deterioration will be compared to baseline from the IDE

  5. 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)

  6. 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.

  7. 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

  8. Dysphagia Handicap Index (DHI) [ Time Frame: 60 Months ]
    Dysphagia Handicap Index (DHI) will be compared to baseline from the IDE



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04630626


Locations
Layout table for location information
United States, California
Orthopaedic Education and Research Institute of Southern California
Orange, California, United States, 92868
USCD
San Diego, California, United States, 92121
The Spine Institute for Spine Restoration
Santa Monica, California, United States, 90403
United States, Colorado
Spine Education and Research Foundation
Thornton, Colorado, United States, 80229
United States, Florida
Kennedy-White orthopedic Center
Sarasota, Florida, United States, 34232
United States, Illinois
NorthShore University Health System
Evanston, Illinois, United States, 60201
United States, Indiana
Indiana Spine Group
Carmel, Indiana, United States, 46032
United States, Kentucky
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, United States, 42003
United States, Louisiana
Spine institute of Louisiana
Shreveport, Louisiana, United States, 71101
United States, New Jersey
Rothman Institute
Egg Harbor Township, New Jersey, United States, 08234
United States, New York
Buffalo Spine Surgery
Lockport, New York, United States, 14094
United States, North Carolina
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States, 28204
United States, Texas
Texas Spine Consultants
Addison, Texas, United States, 75001
Texas Back Institute
Plano, Texas, United States, 75093
United States, Virginia
Virginia Spine Institute
Reston, Virginia, United States, 20191
Sponsors and Collaborators
Simplify Medical Inc.
Layout table for additonal information
Responsible Party: Simplify Medical Inc.
ClinicalTrials.gov Identifier: NCT04630626    
Other Study ID Numbers: P200022 PAS
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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