search
Back to results

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

Primary Purpose

Cervical Disc Degenerative Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
M6-C Artificial Cervical Disc
ACDF
Sponsored by
Spinal Kinetics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Disc Degenerative Disorder focused on measuring artificial cervical disc, degenerative disc disease, total disc replacement, Spinal Kinetics

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Desert Institute for Spine CareRecruiting
  • Beverly Hills Spine SurgeryRecruiting
  • Memorial Orthopaedic Surgical GroupRecruiting
  • UC Irvine Medical CenterRecruiting
  • Institute of Neuro InnovationRecruiting
  • St. Charles Spine InstituteRecruiting
  • University of Colorado School of Medicine - Department of OrthopedicsRecruiting
  • Steadman Philipon Research Institute
  • Hartford Healthcare Bone & Joint Institute
  • Orlando HealthRecruiting
  • Longstreet ClinicRecruiting
  • Axis SpineRecruiting
  • Carle HealthRecruiting
  • Brigham & Women's HospitalRecruiting
  • Baystate HealthRecruiting
  • Michigan Orthopedic SurgeonsRecruiting
  • The Orthopedic Center of St. LouisRecruiting
  • Metropolitan Neurosurgery Associates - Englewood HealthRecruiting
  • Upstate Medical UniversityRecruiting
  • Mayfield ClinicRecruiting
  • Ascension Texas Spine and Scoliosis
  • St. David's HealthcareRecruiting
  • American Neurosurgical Institute/Medical City PlanoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

M6-C Artificial Cervical Disc

Anterior Cervical Discectomy & Fusion (ACDF)

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 17, 2019
Last Updated
September 27, 2023
Sponsor
Spinal Kinetics
search

1. Study Identification

Unique Protocol Identification Number
NCT04982835
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spinal Kinetics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Disc Degenerative Disorder
Keywords
artificial cervical disc, degenerative disc disease, total disc replacement, Spinal Kinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study 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.
Allocation
Non-Randomized
Enrollment
263 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
M6-C Artificial Cervical Disc
Arm Type
Experimental
Arm Description
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).
Arm Title
Anterior Cervical Discectomy & Fusion (ACDF)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
M6-C Artificial Cervical Disc
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
ACDF
Intervention Description
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 Measure Information:
Title
Functional Impairment - Neck Disability Index Score (NDI)
Description
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.
Time Frame
24 Month
Title
Overall Participant Success Rate (M6-C Artificial Cervical Disc)
Description
- Participant success is a composite endpoint of all of the listed Primary Outcome Measures.
Time Frame
24 Month
Title
- Serious Adverse Event(s)
Description
No serious adverse events classified as device or device procedure related (as determined by the Clinical Events Committee).
Time Frame
24 Month
Title
- Additional Surgical Intervention
Description
No supplemental surgical procedure at the index level(s) including supplemental fixation, revision and/or device removal.
Time Frame
24 Month
Title
- Neurologic Function
Description
Maintenance or improvement in neurological function as determined by Clinical Events Committee review of neurological exam results.
Time Frame
24 Month
Secondary Outcome Measure Information:
Title
Neck and Arm Pain
Description
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.
Time Frame
24 Month
Title
Health-Related Quality of Life
Description
Maintenance or improvement of health-related quality of life will be evaluated using the SF-12v2 Health Survey.
Time Frame
24 Month
Title
Radiographic Assessments
Description
Quantitative and qualitative assessments compared to baseline evaluating surgical success outcomes for both cohorts.
Time Frame
24 Month
Title
FOSS Dysphagia Scale
Description
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.
Time Frame
24 Month
Title
Odom's Criteria
Description
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.
Time Frame
24 Month
Title
Patient Satisfaction
Description
A brief Participant Satisfaction Questionnaire (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied) regarding the outcome of their surgery at two-years.
Time Frame
24 Month
Title
Pain Medication Usage
Description
Change in usage of post-operative pain medications specifically prescribed for cervical spine will be documented.
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trai curtis
Phone
214-937-3225
Email
traiCurtis@orthofix.com
First Name & Middle Initial & Last Name or Official Title & Degree
Stuart Pratt
Phone
901-238-5834
Email
stuartpratt@orthofix.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Phillips, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Desert Institute for Spine Care
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Camoriano
Email
Jennifer@jehnresearch.com
Facility Name
Beverly Hills Spine Surgery
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Phillips
Email
research@spinemd.com
First Name & Middle Initial & Last Name & Degree
Deborah Devlin
Email
manager@spinemd.com
Facility Name
Memorial Orthopaedic Surgical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nanette Soto
Email
nanettemsoto@gmail.com
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandon Lehman
Email
bdlehman@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Ethan Lai
Email
laiew@hs.uci.edu
Facility Name
Institute of Neuro Innovation
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jack Petros
Email
research@inifoundation.org
Facility Name
St. Charles Spine Institute
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91860
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Doran, PA-C
Phone
805-379-2322
Email
emily@stcharlesspine.com
First Name & Middle Initial & Last Name & Degree
Andrew Schotte, PA-C
Email
abschotte@stcharlesspine.com
Facility Name
University of Colorado School of Medicine - Department of Orthopedics
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aubrie Nuccio
Email
Aubrie.Nuccio@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Jiandong Hao
Phone
303-724-7457
Email
Jiandong.Hao@cuanschutz.edu
Facility Name
Steadman Philipon Research Institute
City
Vail
State/Province
Colorado
ZIP/Postal Code
81657
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luz Thede
Email
lthede@sprivail.org
First Name & Middle Initial & Last Name & Degree
Brandon Albin
Email
balbin@thesteadmanclinic.com
Facility Name
Hartford Healthcare Bone & Joint Institute
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Withdrawn
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlene Carlo
Email
Charlene.Carlo@orlandohealth.com
First Name & Middle Initial & Last Name & Degree
Francheska Monserrate
Email
Francheska.Monserrate@orlandohealth.com
Facility Name
Longstreet Clinic
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacey May-Franklin
Email
Stacey.may@longstreetclinic.com
Facility Name
Axis Spine
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83815
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisa Maples, BS, CCRC
Phone
208-664-0290
Email
Elisa.Maples@NWSH.com
First Name & Middle Initial & Last Name & Degree
Katelyn Chemodurow
Phone
208-664-0291
Email
Katelyn.Chemodurow@NWSH.com
Facility Name
Carle Health
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carly Skadden
Email
Carly.Skadden@carle.com
First Name & Middle Initial & Last Name & Degree
Hope Carlson
Email
Hope.Carlson@carle.com
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nafisa Masud
Email
nmasud@bwh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Kimberly Lopez Vasquez
Email
klopezvasquez@bwh.harvard.edu
Facility Name
Baystate Health
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andres Santana
Phone
413-794-4231
Email
Andres.Santana@baystatehealth.org
First Name & Middle Initial & Last Name & Degree
Shaula Paul
Phone
413-794-0291
Email
Shaula.Paul2@baystatehealth.org
Facility Name
Michigan Orthopedic Surgeons
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Van Schouwen
Email
kelly@researchtex.com
First Name & Middle Initial & Last Name & Degree
Robin Keswani
Email
robin@researchtex.com
Facility Name
The Orthopedic Center of St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frannie Schranck
Email
fschranck@spirittresearch.com
First Name & Middle Initial & Last Name & Degree
Sarah Conners
Email
sconners@spirittresearch.com
Facility Name
Metropolitan Neurosurgery Associates - Englewood Health
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delcia Fuentes
Phone
201-608-2234
Email
Delcia.Fuentes@EHMCHealth.org
First Name & Middle Initial & Last Name & Degree
Shannon Gilgallon
Phone
201-569-7737
Email
shannon@mnamd.com
Facility Name
Upstate Medical University
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Craig
Email
craigt@upstate.edu
Facility Name
Mayfield Clinic
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Murphy
Phone
513-569-5272
Email
lmurphy@mayfieldclinic.com
First Name & Middle Initial & Last Name & Degree
Sonya Lipp
Phone
513-569-5351
Email
slipp@mayfieldclinic.com
Facility Name
Ascension Texas Spine and Scoliosis
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Devender Singh
Phone
512-324-3580
Email
dpsingh@ascension.org
First Name & Middle Initial & Last Name & Degree
Ashley Duncan
Email
aduncan@ascension.org
Facility Name
St. David's Healthcare
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krishna Saini
Phone
512-544-8070
Email
krishna.saini@stdavids.com
Facility Name
American Neurosurgical Institute/Medical City Plano
City
Frisco
State/Province
Texas
ZIP/Postal Code
75033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ezioma Akwara
Email
Ezioma.Akwara@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Pauline Matheri
Email
Pauline.Matheri@hcahealthcare.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs