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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
156
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.
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.
Desert Institute for Spine Care
Phoenix, Arizona, United States
Functional Impairment - Neck Disability Index Score (NDI)
Change in condition-specific functional impairment will be evaluated using a 10 item NDI outcomes questionnaire to assess change in the functional impairment score. NDI scores range from 0-50 (0%-100%) with higher scores demonstrating greater disability.
Time frame: 24 Month
Overall Participant Success Rate (M6-C Artificial Cervical Disc)
\- Participant success is a composite endpoint of all of the listed Primary Outcome Measures.
Time frame: 24 Month
- Serious Adverse Event(s)
No serious adverse events classified as device or device procedure related (as determined by the Clinical Events Committee).
Time frame: 24 Month
- Additional Surgical Intervention
No supplemental surgical procedure at the index level(s) including supplemental fixation, revision and/or device removal.
Time frame: 24 Month
- Neurologic Function
Maintenance or improvement in neurological function as determined by Clinical Events Committee review of neurological exam results.
Time frame: 24 Month
Neck and Arm Pain
Change in severity of neck and arm pain will be evaluated on a 10-cm Visual Analog Scale (VAS). Zero = no pain, 10 = worst possible pain.
Time frame: 24 Month
Health-Related Quality of Life
Maintenance or improvement of health-related quality of life will be evaluated using the SF-12v2 Health Survey.
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Beverly Hills Spine Surgery
Beverly Hills, California, United States
Memorial Orthopaedic Surgical Group
Long Beach, California, United States
Disc Sports & Spine Center
Newport Beach, California, United States
UC Irvine Medical Center
Orange, California, United States
Institute of Neuro Innovation
Santa Monica, California, United States
St. Charles Spine Institute
Thousand Oaks, California, United States
University of Colorado School of Medicine - Department of Orthopedics
Aurora, Colorado, United States
Steadman Philipon Research Institute
Vail, Colorado, United States
Orlando Health
Orlando, Florida, United States
...and 11 more locations
Time frame: 24 Month
Radiographic Assessments
Quantitative and qualitative assessments compared to baseline evaluating surgical success outcomes for both cohorts.
Time frame: 24 Month
FOSS Dysphagia Scale
The five-stage Functional Outcome Swallowing Scale (FOSS) will be used to determine presence/absence of post-operative oropharyngeal dysphagia and severity of the disorder and outcome. On the 0 to 4 FOSS scale, 0=normal; asymptomatic, whereas 5=severe dysphagia; nonoral feeding.
Time frame: 24 Month
Odom's Criteria
Physician assessment of the clinical disposition of a participant at two-years using the 4-point rating scale (excellent, good, satisfactory, poor) for assessing the clinical outcome after cervical spine surgery.
Time frame: 24 Month
Patient Satisfaction
A brief Participant Satisfaction Questionnaire (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied) regarding the outcome of their surgery at two-years.
Time frame: 24 Month
Pain Medication Usage
Change in usage of post-operative pain medications specifically prescribed for cervical spine will be documented.
Time frame: 24 Months