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|ClinicalTrials.gov Identifier: NCT01609374|
Recruitment Status : Unknown
Verified March 2019 by Spinal Kinetics.
Recruitment status was: Active, not recruiting
First Posted : June 1, 2012
Last Update Posted : September 18, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Radiculopathy Degenerative Disc Disease||Device: M6-C Artificial Cervical Disc Device: Anterior plate system with corticocancellous allograft bone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||258 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||non-randomized, concurrent ACDF control|
|Masking:||None (Open Label)|
|Masking Description:||since the study is concurrently controlled, masking is not possible|
|Official Title:||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|
|Actual Study Start Date :||May 2014|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
|Experimental: M6-C Artificial Cervical Disc||
Device: M6-C Artificial Cervical Disc
Total disc replacement
|Active Comparator: Anterior Cervical Discectomy and Fusion||
Device: Anterior plate system with corticocancellous allograft bone
- Safety Evaluation through 24 months [ Time Frame: 24 months ]Evaluate the safety by assessing adverse events and neurological function following implantation with the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF)
- Effectiveness Evaluation through 24 months [ Time Frame: 24 months ]Evaluate the effectiveness using Neck Disability Index (NDI)
- Effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) [ Time Frame: 6 weeks, 3 months, 6 months, 12 months, 24 months ]Evaluate the Neck and Arm pain VAS, health-related quality of life SF-36, surgery outcomes, patient satisfaction and quantitative and qualitative radiographic assessments