NCT01609374

Restore CLINICAL TRIAL

Prospective, Non-Randomized, 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 Symptomatic Cervical Radiculopathy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Spinal Kinetics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a 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 symptomatic cervical radiculopathy with or without cord compression. Some participating sites will enroll just M6-C patients, while others will enroll just ACDF patients. Patients eligible for study enrollment will present with degenerative cervical radiculopathy requiring surgical intervention, confirmed clinically and radiographically, at one vertebral level from C3 to C7. A total of 243 subjects will be included at up to 20 sites.

Conditions

• Cervical Radiculopathy
• Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	M6-C Artificial Cervical Disc	Total disc replacement
DEVICE	Anterior plate system with corticocancellous allograft bone	Cervical fusion

Timeline

• Start date: 2014-05-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2012-06-01
• Last updated: 2019-09-18