- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04122248
M6-C Post Approval Study (PAS)
M6-C Artificial Cervical Disc IDE Post Approval Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
California
-
Sunnyvale, California, United States, 94085
- Spinal Kinetics, LLC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Since the subjects have already been screened as part of the IDE's pivotal study, and only subjects that participated in that study make up the subject cohort for this long-term follow-up study, there are no additional inclusion criteria
Exclusion Criteria:
- Subjects who were withdrawn or withdrew consent to participate in the investigation
- Subjects who do not consent to participate in long-term follow-up or provide personal contact information to the sponsor (solely for the purposes of tracking subjects to help ensure follow-up compliance)
- Patients with terminal failures (SSI or device- or procedure-related SAE) by Month 24 and all known patient deaths in the M6-C IDE study are excluded for enrollment into the PAS
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
M6-C
Subjects treated with an M6-C device
|
standard radiographic imaging
|
ACDF
Subjects treated with Anterior Cervical Discectomy and Fusion (ACDF)
|
standard radiographic imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall subject success
Time Frame: 10 year follow-up
|
A study subject will be considered an overall success if he/she meets the following criteria:
|
10 year follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck Disability Index (NDI)
Time Frame: annually to 10 years
|
The NDI is a patient reported outcome questionnaire for the measurement of pain and function related to cervical spine problems.
A total NDI score is determined by adding the scores of the individual questions and dividing that total by the maximum possible score (i.e., 50 if all questions are answered) to yield a percentage.
Therefore, the NDI score ranges from 0% to 100%.
A lower score represents less pain and dysfunction.
|
annually to 10 years
|
Neck and arm pain
Time Frame: annually to 10 years
|
A visual analogue scale is a patient reported outcome measure utilized to determine neck and arm pain on a zero to ten scale with zero being the least amount of pain and 10 the most possible pain.
|
annually to 10 years
|
SF-36 Health Survey
Time Frame: annually to 10 years
|
The SF-36 is a patient reported outcome questionnaire to measure health-related Quality of Life.
An increase in score from baseline represents an improvement in health.
|
annually to 10 years
|
Patient Satisfaction
Time Frame: annually to 10 years
|
The following 5 point Likert Scale will be used to further assess subject satisfaction:
|
annually to 10 years
|
Odom's Criteria
Time Frame: annually to 10 years
|
At the 5, 7 and 10 year follow-up visits, the Investigator will rate the clinical disposition of each study subject according to Odom's Criteria[18] as follows: Excellent: No symptoms related to cervical disease. Able to perform daily activities without limitations. Good: Moderate symptoms related to cervical disease. Able to perform daily activities without significant limitations. Satisfactory: Slight improvement is symptoms related to cervical disease. Significant limitations in daily activities. Poor: No improvement in, or aggravation of, symptoms related to cervical disease. Not able to perform daily activities. |
annually to 10 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CA-C004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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