Clinical trial NCT04982835: M6®-C Artificial Cervical Disc Two-Level IDE Pivotal Study
Official title: M6®-C Artificial Cervical Disc Two-Level IDE Pivotal Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Disc Degenerative Disorder
Keywords: artificial cervical disc
degenerative disc disease
total disc replacement
Spinal Kinetics
Lead sponsor: Orthofix Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-29
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Functional Impairment - Neck Disability Index Score (NDI)
timeFrame: 24 Month
measure: Overall Participant Success Rate (M6-C Artificial Cervical Disc)
timeFrame: 24 Month
measure: - Serious Adverse Event(s)
timeFrame: 24 Month
measure: - Additional Surgical Intervention
timeFrame: 24 Month
measure: - Neurologic Function
timeFrame: 24 Month
Secondary outcomes:
measure: Neck and Arm Pain
timeFrame: 24 Month
measure: Health-Related Quality of Life
timeFrame: 24 Month
measure: Radiographic Assessments
timeFrame: 24 Month
measure: FOSS Dysphagia Scale
timeFrame: 24 Month
measure: Odom's Criteria
timeFrame: 24 Month
measure: Patient Satisfaction
timeFrame: 24 Month
measure: Pain Medication Usage
timeFrame: 24 Months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Desert Institute for Spine Care
state: Arizona
city: Beverly Hills
country: United States
facility: Beverly Hills Spine Surgery
state: California
city: Long Beach
country: United States
facility: Memorial Orthopaedic Surgical Group
state: California
city: Newport Beach
country: United States
facility: Disc Sports & Spine Center
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
city: Santa Monica
country: United States
facility: Institute of Neuro Innovation
state: California
city: Thousand Oaks
country: United States
facility: St. Charles Spine Institute
state: California
city: Aurora
country: United States
facility: University of Colorado School of Medicine - Department of Orthopedics
state: Colorado
city: Vail
country: United States
facility: Steadman Philipon Research Institute
state: Colorado
city: Hartford
country: United States
facility: Hartford Healthcare Bone & Joint Institute
state: Connecticut
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Tampa
country: United States
facility: Joseph Spine Institute
state: Florida
city: Gainesville
country: United States
facility: Longstreet Clinic
state: Georgia
city: Coeur d'Alene
country: United States
facility: Axis Spine
state: Idaho
city: Urbana
country: United States
facility: Carle Health
state: Illinois
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Health
state: Massachusetts
city: Southfield
country: United States
facility: Michigan Orthopedic Surgeons
state: Michigan
city: St. Louis
country: United States
facility: The Orthopedic Center of St. Louis
state: Missouri
city: Englewood
country: United States
facility: Metropolitan Neurosurgery Associates - Englewood Health
state: New Jersey
city: East Syracuse
country: United States
facility: Upstate Medical University
state: New York
city: Cincinnati
country: United States
facility: Mayfield Clinic
state: Ohio
city: Austin
country: United States
facility: Ascension Texas Spine and Scoliosis
state: Texas
city: Austin
country: United States
facility: St. David's Healthcare
state: Texas
city: Frisco
country: United States
facility: American Neurospine Institute/Medical City Frisco
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Medical Center
state: Utah
Study officials:
affiliation: Rush University Medical Center
name: Frank Phillips, MD
role: PRINCIPAL_INVESTIGATOR
References: