NCT04982835

M6-C Artificial Cervical Disc Two-Level IDE Pivotal Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Orthofix Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-C™ artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of contiguous two-level symptomatic cervical radiculopathy at vertebral levels from C3 to C7 with or without spinal cord compression.

Detailed description

Patients will be concurrently enrolled in the M6-C treatment group and the ACDF control group. Patients should have failed at least six weeks of conservative treatment or demonstrate progressive symptoms despite continued non-operative treatment. For the study, 263 patients will undergo either a two-level cervical artificial disc procedure, or an instrumented (ACDF) procedure as per site group assignment. Patients will be evaluated clinically, radiographically, and via the collection of patient-reported outcomes at 6 Weeks, 3 Months, 6 Months, 12 Months and 24 Months. The primary endpoint is Overall Success at 24 Months.

Conditions

• Cervical Disc Degenerative Disorder

Interventions

Type	Name	Description
DEVICE	M6-C Artificial Cervical Disc	An incision will be made in the front of the neck and the damaged disc located between cervical vertebrae (neck bones) will be removed so that the M6-C artificial cervical disc can be placed into the space where the damaged disc was removed. This procedure will be performed using x-ray technology (fluoroscopy) guide the surgeon in placement of the M6-C in between the cervical vertebrae. This process will be repeated to replace the second damaged disc.
DEVICE	ACDF	One of four FDA-approved cervical plate systems will be used for the ACDF. An incision will be made in the front of the neck and the damaged disc located between cervical vertebrae (neck bones) will be removed. Then, a piece of donor bone will be placed in the space where the damaged disc was removed and a metal plate will be screwed into the bones above and below the disc. This procedure will be performed using x-ray technology (fluoroscopy) to guide the surgeon in the placement of the cervical plate system. This process will be repeated to treat the other damaged disc.

Timeline

• Start date: 2021-07-26
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2021-07-29
• Last updated: 2025-11-14

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated device study