M6-C Post Approval Study (PAS)

Spinal Kinetics

Status: Active, not recruiting

Conditions: Cervical Spinal Cord Compression; Cervical Disc Herniation; Cervical Radiculopathy; Cervical Degenerative Disc Disease

Treatments: Other: standard radiographic imaging; Device: cervical total disc replacement

Study type: Observational

Funder types: Industry

Identifiers

NCT04122248

CA-C004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 patients

Sex: All

Ages: 21 to 68 years old

Volunteers: No Healthy Volunteers

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• Subjects who were withdrawn or withdrew consent to participate in the investigation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

Trial design

152 participants in 2 patient groups

M6-C

Description:

Subjects treated with an M6-C device

Treatment:

Device: cervical total disc replacement

Other: standard radiographic imaging

ACDF

Description:

Subjects treated with Anterior Cervical Discectomy and Fusion (ACDF)

Treatment:

Other: standard radiographic imaging