M6-C Post Approval Study (PAS)

N/AActive Not RecruitingNCT04122248

Spinal Kinetics152 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

152

Conditions

Cervical Degenerative Disc Disease Cervical Radiculopathy Cervical Spinal Cord Compression Cervical Disc Herniation

Interventions

standard radiographic imagingOTHER

standard radiographic imaging

cervical total disc replacementDEVICE

Artificial disc replacement (ADR) in the cervical spine is a minimally invasive procedure that involves removing diseased disc tissue and replacing it with an artificial disc. The artificial disc is designed to preserve the spine\'s natural motion while remaining securely attached to the surrounding vertebral bones. The goal of ADR is to help preserve the motion of the cervical spine or spinal segment after surgery, which can improve the quality of life for patients.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 68 Years

Medical Language ↔ Plain English

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for this long-term follow-up study, there are no additional inclusion criteria Exclusion Criteria: * Subjects who were withdrawn or withdrew consent to participate in the investigation * Subjects who do not consent to participate in long-term follow-up or provide personal contact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

Locations (21)

Desert Institute for Spine Care

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

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.

Time frame: 10 year follow-up

Secondary Outcomes

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.

Time frame: annually to 10 years

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.

Time frame: annually to 10 years

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.

Time frame: annually to 10 years

Patient Satisfaction

The following 5 point Likert Scale will be used to further assess subject satisfaction: 1. How satisfied are you with the results of your surgery? Very Satisfied; Satisfied; Neutral; Unsatisfied; Very Unsatisfied 2. All things considered, would you have the surgery again? Very likely; likely; not sure; Unlikely; Very Unlikely 3. Would you recommend the surgery to a friend or family member? Very likely; likely; not sure; Unlikely; Very Unlikely

Data from ClinicalTrials.gov

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