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

Not Applicable

Recruiting

• Conditions: Cervical Disc Degenerative Disorder

• Registration Number: NCT04982835
• Lead Sponsor: Spinal Kinetics

Brief 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.

Study Timeline

• Study First Submitted: 2019-09-17
• Study First Submitted QC: 2021-07-23
• Study Start: 2021-07-26
• Study First Posted: 2021-07-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-25
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 263

Inclusion Criteria

• Diagnosis of degenerative cervical radiculopathy with or without spinal cord compression requiring surgical treatment at two contiguous levels from C3 to C7 demonstrated by signs and/or symptoms of disc herniation and/or osteophyte formation (e.g. neck and/or arm pain, radiculopathy, etc.) and is confirmed by patient history and radiographic studies (e.g. MRI, CT, x-rays, etc.)
• Inadequate response to conservative medical care over a period of at least 6 weeks or have the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management
• Neck Disability Index score of ≥ 30% (raw score of ≥ 15/50)
• Neck or arm pain Visual Analog Scale Score ≥ 4 on a scale of 0 to 10
• Willing and able to comply with the requirements of the protocol including follow-up requirements
• Willing and able to sign a study specific informed consent
• Skeletally mature and at least 18 years old but not older than 75 years old

Exclusion Criteria

• More than two cervical levels requiring surgery, or two non-contiguous levels requiring surgery
• Previous anterior cervical spine surgery
• Axial neck pain as the solitary symptom
• Previous posterior cervical spine surgery (such as a posterior element decompression) that destabilizes the cervical spine
• Advanced cervical anatomical deformity (such as ankylosing spondylitis, scoliosis) at either of the operative levels or adjacent levels
• Symptomatic facet arthrosis
• Less than four degrees of motion in flexion/extension at either of the index levels
• Instability as evidenced by subluxation greater than 3 millimeters at either of the index or adjacent levels as indicated on flexion/extension x-rays.
• Advanced degenerative changes (e.g., spondylosis) at either of the index vertebral levels as evidenced by bridging osteophytes, central disc height less than 4 millimeters and/or < 50% of the adjacent normal intervertebral disc, or kyphotic deformity > 11 degrees on neutral x-rays
• Severe cervical myelopathy (i.e., Nurick's Classification greater than 2)
• Active systemic infection or infection at the operative site
• Co-morbid medical conditions of the spine or upper extremities that may affect the cervical spine neurological and/or pain assessment
• Metabolic bone disease such as osteoporosis that contradicts spinal surgery
• History of an osteoporotic fracture of the spine, hip or wrist
• History of an endocrine or metabolic disorder (e.g. Paget's disease) known to affect bone and mineral metabolism
• Taking medications that may interfere with bony/soft tissue healing including chronic steroid use
• Known allergy to titanium, stainless steels, polyurethane, polyethylene, or ethylene oxide residuals
• Fibromyalgia, Rheumatoid Arthritis (or other autoimmune disease), or a systemic disorder such as HIV or acute hepatitis B or C.
• Insulin dependent diabetes
• Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion
• Pregnant, or intend to become pregnant, during the course of the study
• Severe obesity (Body Mass Index greater than 45)
• Physical or mental condition (e.g. psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain or quality of life.
• Involved in current or pending spinal litigation where permanent disability benefits are being sought.
• Incarcerated at time of study enrollment
• Current participation in other investigational study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
- Serious Adverse Event(s)	24 Month	No serious adverse events classified as device or device procedure related (as determined by the Clinical Events Committee).
- Additional Surgical Intervention	24 Month	No supplemental surgical procedure at the index level(s) including supplemental fixation, revision and/or device removal.
- Neurologic Function	24 Month	Maintenance or improvement in neurological function as determined by Clinical Events Committee review of neurological exam results.
Functional Impairment - Neck Disability Index Score (NDI)	24 Month	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.
Overall Participant Success Rate (M6-C Artificial Cervical Disc)	24 Month	- Participant success is a composite endpoint of all of the listed Primary Outcome Measures.

Secondary Outcome Measures

Name	Time	Method
Neck and Arm Pain	24 Month	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.
Health-Related Quality of Life	24 Month	Maintenance or improvement of health-related quality of life will be evaluated using the SF-12v2 Health Survey.
FOSS Dysphagia Scale	24 Month	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.
Patient Satisfaction	24 Month	A brief Participant Satisfaction Questionnaire (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied) regarding the outcome of their surgery at two-years.
Radiographic Assessments	24 Month	Quantitative and qualitative assessments compared to baseline evaluating surgical success outcomes for both cohorts.
Odom's Criteria	24 Month	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.
Pain Medication Usage	24 Months	Change in usage of post-operative pain medications specifically prescribed for cervical spine will be documented.

Trial Locations

Locations (26)

Desert Institute for Spine Care; 🇺🇸 Phoenix, Arizona, United States

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

Hartford Healthcare Bone & Joint Institute; 🇺🇸 Hartford, Connecticut, United States

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