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| Name | Class |
|---|---|
| Spinal Kinetics | INDUSTRY |
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Prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-Câ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M6-C Artificial Cervical Disc | Experimental | The M6-C is an investigational device composed of two outer and inner endplates made of titanium with a polycarbonate urethane nucleus (plastic center) and a polyethylene fiber annulus (strong thread-like binding). Around the polyethylene annulus is a polyurethane sheath (plastic cover). The outer endplates have keels to anchor the disc to bone. The outer endplates and keels are both coated with a titanium plasma spray. The M6-C is provided in two heights (6mm and 7mm) and four footprints (Medium, Medium Long, Large, Large Long). |
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| Anterior Cervical Discectomy & Fusion (ACDF) | Active Comparator | ACDF will be performed using one of four FDA-approved anterior cervical plate systems and corticocancellous allograft bone. The four plating systems used in this study are:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M6-C Artificial Cervical Disc | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 24 Month |
| - Serious Adverse Event(s) | No serious adverse events classified as device or device procedure related (as determined by the Clinical Events Committee). | 24 Month |
| - Additional Surgical Intervention | No supplemental surgical procedure at the index level(s) including supplemental fixation, revision and/or device removal. | 24 Month |
| - Neurologic Function | Maintenance or improvement in neurological function as determined by Clinical Events Committee review of neurological exam results. | 24 Month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 Month |
| Health-Related Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay Erturan, MD, JD | Orthofix Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desert Institute for Spine Care | Phoenix | Arizona | 85020 | United States | ||
| Beverly Hills Spine Surgery |
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Participants will be assigned a treatment group by enrolling site and will not be blinded to the treatment group assignment before their surgery. Investigator, and site will not be blinded to treatment assignment due to the need to prepare for the respective surgery associated with the treatment assignment.
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| ACDF | Device | 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. |
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Maintenance or improvement of health-related quality of life will be evaluated using the SF-12v2 Health Survey.
| 24 Month |
| Radiographic Assessments | Quantitative and qualitative assessments compared to baseline evaluating surgical success outcomes for both cohorts. | 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. | 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. | 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. | 24 Month |
| Pain Medication Usage | Change in usage of post-operative pain medications specifically prescribed for cervical spine will be documented. | 24 Months |
| Beverly Hills |
| California |
| 90210 |
| United States |
| Memorial Orthopaedic Surgical Group | Long Beach | California | 90806 | United States |
| Disc Sports & Spine Center | Newport Beach | California | 92660 | United States |
| UC Irvine Medical Center | Orange | California | 92868 | United States |
| Institute of Neuro Innovation | Santa Monica | California | 90404 | United States |
| St. Charles Spine Institute | Thousand Oaks | California | 91860 | United States |
| University of Colorado School of Medicine - Department of Orthopedics | Aurora | Colorado | 80045 | United States |
| Steadman Philipon Research Institute | Vail | Colorado | 81657 | United States |
| Orlando Health | Orlando | Florida | 32809 | United States |
| Joseph Spine Institute | Tampa | Florida | 33607 | United States |
| Longstreet Clinic | Gainesville | Georgia | 30801 | United States |
| Axis Spine | Coeur d'Alene | Idaho | 83815 | United States |
| Carle Health | Urbana | Illinois | 61801 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Michigan Orthopedic Surgeons | Southfield | Michigan | 48033 | United States |
| The Orthopedic Center of St. Louis | St Louis | Missouri | 63017 | United States |
| Metropolitan Neurosurgery Associates - Englewood Health | Englewood | New Jersey | 07631 | United States |
| Mayfield Clinic | Cincinnati | Ohio | 45209 | United States |
| St. David's Healthcare | Austin | Texas | 78705 | United States |
| American Neurospine Institute/Medical City Frisco | Frisco | Texas | 75033 | United States |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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