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

Cervical Disc Degenerative Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04982835
• Other study ID #: CA-C003-Pivotal
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2021
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Orthofix Inc.
• Contact: Trai curtis
• Phone: 214-937-3225
• Email: traiCurtis[@]orthofix.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 263
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Disc Degenerative Disorder
• Intervertebral Disc Degeneration

Intervention

Device:
• M6-C Artificial Cervical Disc
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.
• ACDF
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.

Locations

Country	Name	City	State
United States	University of Colorado School of Medicine - Department of Orthopedics	Aurora	Colorado
United States	Ascension Texas Spine and Scoliosis	Austin	Texas
United States	St. David's Healthcare	Austin	Texas
United States	Beverly Hills Spine Surgery	Beverly Hills	California
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Mayfield Clinic	Cincinnati	Ohio
United States	Axis Spine	Coeur d'Alene	Idaho
United States	Upstate Medical University	East Syracuse	New York
United States	Metropolitan Neurosurgery Associates - Englewood Health	Englewood	New Jersey
United States	American Neurospine Institute/Medical City Frisco	Frisco	Texas
United States	Longstreet Clinic	Gainesville	Georgia
United States	Hartford Healthcare Bone & Joint Institute	Hartford	Connecticut
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	Orlando Health	Orlando	Florida
United States	Desert Institute for Spine Care	Phoenix	Arizona
United States	The Orthopedic Center of St. Louis	Saint Louis	Missouri
United States	University of Utah Medical Center	Salt Lake City	Utah
United States	Institute of Neuro Innovation	Santa Monica	California
United States	Michigan Orthopedic Surgeons	Southfield	Michigan
United States	Baystate Health	Springfield	Massachusetts
United States	Joseph Spine Institute	Tampa	Florida
United States	St. Charles Spine Institute	Thousand Oaks	California
United States	Carle Health	Urbana	Illinois
United States	Steadman Philipon Research Institute	Vail	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Spinal Kinetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	- Serious Adverse Event(s)	No serious adverse events classified as device or device procedure related (as determined by the Clinical Events Committee).	24 Month
Primary	- Additional Surgical Intervention	No supplemental surgical procedure at the index level(s) including supplemental fixation, revision and/or device removal.	24 Month
Primary	- Neurologic Function	Maintenance or improvement in neurological function as determined by Clinical Events Committee review of neurological exam results.	24 Month
Secondary	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
Secondary	Health-Related Quality of Life	Maintenance or improvement of health-related quality of life will be evaluated using the SF-12v2 Health Survey.	24 Month
Secondary	Radiographic Assessments	Quantitative and qualitative assessments compared to baseline evaluating surgical success outcomes for both cohorts.	24 Month
Secondary	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
Secondary	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
Secondary	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
Secondary	Pain Medication Usage	Change in usage of post-operative pain medications specifically prescribed for cervical spine will be documented.	24 Months