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

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ClinicalTrials.gov Identifier: NCT04982835
Recruitment Status : Recruiting
First Posted : July 29, 2021
Last Update Posted : December 9, 2022
Information provided by (Responsible Party):
Orthofix Inc. ( 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.

Condition or disease Intervention/treatment Phase
Cervical Disc Degenerative Disorder Device: M6-C Artificial Cervical Disc Device: ACDF Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 263 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: M6®-C Artificial Cervical Disc Two-Level IDE Pivotal Study
Actual Study Start Date : July 26, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: M6-C Artificial Cervical Disc
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).
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.

Active Comparator: Anterior Cervical Discectomy & Fusion (ACDF)

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:

  • Orthofix CETRA Anterior Cervical Plate System
  • Medtronic Sofamor/Danek Venture Anterior Cervical Plate System
  • DePuy Synthes: SKYLINE Anterior Cervical Plate System
  • Stryker Aviator Anterior Cervical Plating System
Device: 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.

Primary Outcome Measures :
  1. Functional Impairment - Neck Disability Index Score (NDI) [ Time Frame: 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.

  2. Overall Participant Success Rate (M6-C Artificial Cervical Disc) [ Time Frame: 24 Month ]
    - Participant success is a composite endpoint of all of the listed Primary Outcome Measures.

  3. - Serious Adverse Event(s) [ Time Frame: 24 Month ]
    No serious adverse events classified as device or device procedure related (as determined by the Clinical Events Committee).

  4. - Additional Surgical Intervention [ Time Frame: 24 Month ]
    No supplemental surgical procedure at the index level(s) including supplemental fixation, revision and/or device removal.

  5. - Neurologic Function [ Time Frame: 24 Month ]
    Maintenance or improvement in neurological function as determined by Clinical Events Committee review of neurological exam results.

Secondary Outcome Measures :
  1. Neck and Arm Pain [ Time Frame: 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.

  2. Health-Related Quality of Life [ Time Frame: 24 Month ]
    Maintenance or improvement of health-related quality of life will be evaluated using the SF-12v2 Health Survey.

  3. Radiographic Assessments [ Time Frame: 24 Month ]
    Quantitative and qualitative assessments compared to baseline evaluating surgical success outcomes for both cohorts.

  4. FOSS Dysphagia Scale [ Time Frame: 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.

  5. Odom's Criteria [ Time Frame: 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.

  6. Patient Satisfaction [ Time Frame: 24 Month ]
    A brief Participant Satisfaction Questionnaire (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied) regarding the outcome of their surgery at two-years.

  7. Pain Medication Usage [ Time Frame: 24 Months ]
    Change in usage of post-operative pain medications specifically prescribed for cervical spine will be documented.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04982835

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Contact: Trai curtis 214-937-3225 traiCurtis@orthofix.com
Contact: Stuart Pratt 901-238-5834 stuartpratt@orthofix.com

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United States, Arizona
Desert Institute for Spine Care Recruiting
Phoenix, Arizona, United States, 85020
Contact: Jennifer Camoriano       Jennifer@jehnresearch.com   
United States, California
Beverly Hills Spine Surgery Recruiting
Beverly Hills, California, United States, 90210
Contact: Nicole Phillips       research@spinemd.com   
Contact: Deborah Devlin       manager@spinemd.com   
Memorial Orthopaedic Surgical Group Recruiting
Long Beach, California, United States, 90806
Contact: Nanette Soto       nanettemsoto@gmail.com   
UC Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Christian Tejeda       cjtejeda@hs.uci.edu   
Contact: Brandon Lehman       bdlehman@hs.uci.edu   
Institute of Neuro Innovation Recruiting
Santa Monica, California, United States, 90404
Contact: Jack Petros       research@inifoundation.org   
United States, Florida
Orlando Health Recruiting
Orlando, Florida, United States, 32809
Contact: Charlene Carlo       Charlene.Carlo@orlandohealth.com   
Contact: Tiffany Gilliard       Tiffany.Gilliard@orlandohealth.com   
United States, Georgia
Longstreet Clinic Recruiting
Gainesville, Georgia, United States, 30801
Contact: Stacey May-Franklin       Stacey.may@longstreetclinic.com   
Contact: Amanda Shockley       Amanda.shockley@longstreetclinic.com   
United States, Illinois
Carle Health Recruiting
Urbana, Illinois, United States, 61801
Contact: Carly Skadden       Carly.Skadden@carle.com   
Contact: Hope Carlson       Hope.Carlson@carle.com   
United States, Massachusetts
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Nafisa Masud       nmasud@bwh.harvard.edu   
Contact: Kimberly Lopez Vasquez       klopezvasquez@bwh.harvard.edu   
United States, Michigan
Michigan Orthopedic Surgeons Recruiting
Southfield, Michigan, United States, 48033
Contact: Kelly Van Schouwen       kelly@researchtex.com   
Contact: Robin Keswani       robin@researchtex.com   
United States, Missouri
The Orthopedic Center of St. Louis Recruiting
Saint Louis, Missouri, United States, 63017
Contact: Frannie Schranck       fschranck@spirittresearch.com   
Contact: Sarah Conners       sconners@spirittresearch.com   
United States, New Jersey
Metropolitan Neurosurgery Associates - Englewood Health Recruiting
Englewood, New Jersey, United States, 07631
Contact: Elvira Tsague    201-894-3000    elvira.tsague@ehmchealth.org   
Contact: Shannon Gilgallon    201-569-7737    shannon@mnamd.com   
United States, New York
Upstate Medical University Recruiting
East Syracuse, New York, United States, 13057
Contact: Tina Craig       craigt@upstate.edu   
United States, Texas
St. David's Healthcare Not yet recruiting
Austin, Texas, United States, 78705
Contact: Krishna Saini    512-544-8070    krishna.saini@stdavids.com   
American Neurosurgical Institute/Medical City Plano Recruiting
Plano, Texas, United States, 75075
Contact: Rocio Sauder       rocio.sauder@hcahealthcare.com   
Contact: Pauline Matheri       Pauline.Matheri@hcahealthcare.com   
Sponsors and Collaborators
Spinal Kinetics
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Principal Investigator: Frank Phillips, MD Rush University Medical Center
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Responsible Party: Spinal Kinetics
ClinicalTrials.gov Identifier: NCT04982835    
Other Study ID Numbers: CA-C003-Pivotal
First Posted: July 29, 2021    Key Record Dates
Last Update Posted: December 9, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Orthofix Inc. ( Spinal Kinetics ):
artificial cervical disc
degenerative disc disease
total disc replacement
Spinal Kinetics
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases