M6-C Post Approval Study (PAS)

Long Term Follow-up Clinical Trial

Official title:

M6-C Artificial Cervical Disc IDE Post Approval Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04122248
• Other study ID #: CA-C004
• Status: Enrolling by invitation
• Start date: November 30, 2019
• Est. completion date: June 30, 2026

Study information

• Verified date: October 2019
• Source: Spinal Kinetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The M6-C Post Approval Study is a long term follow-up study of subjects previously enrolled and treated in the M6-C Artificial Cervical Disc IDE Study.

Description:

A prospective, concurrently controlled, multi-center pivotal study to evaluate the safety and effectiveness of the M6-C™ Artificial Cervical Disc compared to anterior cervical discectomy and fusion (ACDF) was performed in the United States under IDE #G050254. To fulfill the concurrent control design of the study, there were clinical sites that evaluated the safety and effectiveness of the M6-C™ Artificial Cervical Disc and there were other clinical sites that evaluated ACDF. Subjects in the study were treated between May 2014 and June 2016 and remain in follow-up. The M6-C™ Artificial Cervical Disc received FDA approval to market on February 6, 2019. As a condition of approval, the FDA requested that the sponsor perform a post market approval study (PAS). The subjects enrolled and remaining in the M6-C IDE pivotal study are the prospective patient population for the PAS.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 208
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 68 Years

Eligibility

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• Subjects who were withdrawn or withdrew consent to participate in the investigation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

Related Conditions & MeSH terms

• Long Term Follow-up

Intervention

Other:
• standard radiographic imaging
standard radiographic imaging

Locations

Country	Name	City	State
United States	Spinal Kinetics, LLC	Sunnyvale	California

Sponsors (1)

Lead Sponsor	Collaborator
Spinal Kinetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall subject success	A study subject will be considered an overall success if he/she meets the following criteria: No serious adverse event(s) classified as device or device procedure related (as determined by the CEC), and; No subsequent surgical procedure at the index level (including revision, removal, reoperation, or supplemental fixation), and; Maintenance or improvement in neurological function, and; Improvement on the NDI of at least 15 points.	10 year follow-up
Secondary	Neck Disability Index (NDI)	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
Secondary	Neck and arm pain	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
Secondary	SF-36 Health Survey	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
Secondary	Patient Satisfaction	The following 5 point Likert Scale will be used to further assess subject satisfaction: How satisfied are you with the results of your surgery? Very Satisfied; Satisfied; Neutral; Unsatisfied; Very Unsatisfied; All things considered, would you have the surgery again? Very likely; likely; not sure; Unlikely; Very Unlikely; Would you recommend the surgery to a friend or family member? Very likely; likely; not sure; Unlikely; Very Unlikely	annually to 10 years
Secondary	Odom's Criteria	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