Back to results2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C (SMART)
Primary Purpose
Symptomatic Cervical Disc Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
prodisc C SK and/or Vivo
Mobi-C Cervical Disc
Sponsored by
About this trial
This is an interventional treatment trial for Symptomatic Cervical Disc Disease focused on measuring symptomatic cervical disc disease, SCDD, neck pain, radiculopathy, myelopathy, cervical spine pain, neck surgery, cervical surgery, arm numbness, hand numbness, arm tingling, hand tingling, arm weakness
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 and ≤69 years.
- Diagnosis of radiculopathy or myelopathy with radiculopathy of the cervical spine, with pain, paresthesias or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following:
- Symptomatic cervical disc disease (SCDD) at two contiguous levels from C3 to C7.
- Radiographically determined pathology at the level to be treated correlating to primary symptoms.
- Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics)
Exclusion Criteria:
- Have more than one immobile vertebral level between C1 to C7 from any cause including but not limited to congenital abnormalities and osteoarthritic "spontaneous" fusions.
- Have previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury.
- Have had a prior cervical TDR or fusion procedure at any level.
- Have osteoporosis or is at increased risk of osteoporosis
- Have active malignancy that included a history of any invasive malignancy (except non-melanoma skin cancer), unless the subject had been treated with curative intent and there had been no clinical signs or symptoms of the malignancy for at least 5 years.
- Have known allergies to cobalt, chromium, molybdenum, titanium, nickel or polyethylene.
- Have rheumatoid arthritis, lupus, or other autoimmune disease that affect the musculoskeletal system.
- Have concomitant conditions requiring daily, high-dose oral and/or inhaled steroids.
- Have a Body Mass Index (BMI) > 40 kg/m2.
- Taking medications known to potentially interfere with bone/soft tissue healing (e.g., high-dose oral and/or inhaled steroids, immunosuppressant medication, chemotherapeutic agents).
- Have a current history of heavy smoking (more than one pack of cigarettes per day).
Sites / Locations
- Flagstaff Bone and JointRecruiting
- Todd Lanman, MD, Inc.Recruiting
- Doctors Outpatient Center for SurgeryRecruiting
- Sutter Health - Palo Alto Medical FoundationRecruiting
- Sutter HealthRecruiting
- Sky Ridge Medical Center CampusRecruiting
- Center for Spine and Orthopedics, Scientific Education and Research FoundationRecruiting
- Georgetown University HospitalRecruiting
- St. Vincent's NeurosurgeryRecruiting
- Kennedy-White Orthopaedic CenterRecruiting
- University of South FloridaRecruiting
- Florida Orthopaedic InstituteRecruiting
- Legacy Brain and SpineRecruiting
- Indiana Spine GroupRecruiting
- Orthopaedic Institute of Western KentuckyRecruiting
- Spine Institute of LouisianaRecruiting
- University of Maryland Medical CenterRecruiting
- William Beaumont HospitalRecruiting
- Las Vegas Neurosurgical Institute for Spine and Brain Surgery
- University Spine Center
- NYU Langone Orthopedic HospitalRecruiting
- Hospital for Special SurgeryRecruiting
- Northwell Health, Lenox Hill HospitalRecruiting
- Axis Neurosurgery and SpineRecruiting
- M3-Emerging Medical ResarchRecruiting
- Beachwood Medical CenterRecruiting
- St. Vincent Charity Medical Group
- Penn State Milton S. Hershey Medical CenterRecruiting
- DFW Center for Spinal DisordersRecruiting
- Texas Back InstituteRecruiting
- Texas Spine Care CenterRecruiting
- The Disc Replacement CenterRecruiting
- Multicare Neurosurgery and SpineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Investigational
Control
Arm Description
Two-level prodisc C SK and/or prodisc C Vivo
Two-level Mobi-C device
Outcomes
Primary Outcome Measures
Composite clinical success rate of the two-level prodisc C SK and prodisc C Vivo will be no worse than marketed cervical disc prosthesis (Mobi-C)
Includes assessments such as NDI and neurological improvement.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04012996
Brief Title
2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
Acronym
SMART
Official Title
A Multi-Center, Prospective, Randomized Controlled Trial Comparing the Safety and Effectiveness of Prodisc® C SK and Prodisc® C Vivo to Mobi-C® Cervical Disc in the Treatment of Two-Level Symptomatic Cervical Disc Disease (SCDD)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
February 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centinel Spine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and prodisc C Vivo to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD).
Detailed Description
The clinical trial is to demonstrate that prodisc C SK and prodisc C Vivo are at least as safe and effective as a similar, currently marketed cervical disc prosthesis to treat symptomatic cervical disc disease (SCDD) in subjects at two contiguous levels from C3 to C7 who are unresponsive to conservative management. Subjects will be randomized in a 2:1 ratio to either the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group). Subjects will be followed for at least 2 years and up to 5 years. Subjects will be required to complete subject questionnaires, have X-rays and undergo neurological assessments during the follow up visits as specified in the protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Cervical Disc Disease
Keywords
symptomatic cervical disc disease, SCDD, neck pain, radiculopathy, myelopathy, cervical spine pain, neck surgery, cervical surgery, arm numbness, hand numbness, arm tingling, hand tingling, arm weakness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
multi-center, prospective, randomized, controlled comparison
Masking
Participant
Masking Description
Patient is blinded to their treatment randomization until after surgery.
Allocation
Randomized
Enrollment
390 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Investigational
Arm Type
Experimental
Arm Description
Two-level prodisc C SK and/or prodisc C Vivo
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Two-level Mobi-C device
Intervention Type
Device
Intervention Name(s)
prodisc C SK and/or Vivo
Intervention Description
Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).
Intervention Type
Device
Intervention Name(s)
Mobi-C Cervical Disc
Intervention Description
Subjects will be randomized in a 2:1 ratio either to the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group).
Primary Outcome Measure Information:
Title
Composite clinical success rate of the two-level prodisc C SK and prodisc C Vivo will be no worse than marketed cervical disc prosthesis (Mobi-C)
Description
Includes assessments such as NDI and neurological improvement.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥18 and ≤69 years.
Diagnosis of radiculopathy or myelopathy with radiculopathy of the cervical spine, with pain, paresthesias or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following:
Symptomatic cervical disc disease (SCDD) at two contiguous levels from C3 to C7.
Radiographically determined pathology at the level to be treated correlating to primary symptoms.
Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics)
Exclusion Criteria:
Have more than one immobile vertebral level between C1 to C7 from any cause including but not limited to congenital abnormalities and osteoarthritic "spontaneous" fusions.
Have previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury.
Have had a prior cervical TDR or fusion procedure at any level.
Have osteoporosis or is at increased risk of osteoporosis
Have active malignancy that included a history of any invasive malignancy (except non-melanoma skin cancer), unless the subject had been treated with curative intent and there had been no clinical signs or symptoms of the malignancy for at least 5 years.
Have known allergies to cobalt, chromium, molybdenum, titanium, nickel or polyethylene.
Have rheumatoid arthritis, lupus, or other autoimmune disease that affect the musculoskeletal system.
Have concomitant conditions requiring daily, high-dose oral and/or inhaled steroids.
Have a Body Mass Index (BMI) > 40 kg/m2.
Taking medications known to potentially interfere with bone/soft tissue healing (e.g., high-dose oral and/or inhaled steroids, immunosuppressant medication, chemotherapeutic agents).
Have a current history of heavy smoking (more than one pack of cigarettes per day).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Kuras
Phone
484.887.8873
Email
j.kuras@centinelspine.com
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Jensen
Email
m.jensen@centinelspine.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Kuras
Organizational Affiliation
Centinel Spine
Official's Role
Study Director
Facility Information:
Facility Name
Flagstaff Bone and Joint
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cari Nelson
Email
c.nelson@flagstaffboneandjoint.com
Facility Name
Todd Lanman, MD, Inc.
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 Philips
Email
research@spine.md
Facility Name
Doctors Outpatient Center for Surgery
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Babak Khandehroo, MD
Email
research@docsspineortho.com
Facility Name
Sutter Health - Palo Alto Medical Foundation
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Becky Roberts
Email
Rebecca.Roberts@sutterhealth.org
First Name & Middle Initial & Last Name & Degree
Tatyana Pozniansky
Email
Tatyana.Pozniansky@sutterhealth.org
Facility Name
Sutter Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sampreet Moneski
Email
kaurs7@sutterhealth.org
Facility Name
Sky Ridge Medical Center Campus
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Malecha
Email
Emily.Malecha@HCAhealthcare.com
Facility Name
Center for Spine and Orthopedics, Scientific Education and Research Foundation
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rianna Jackson
Email
JacksonR@centerforspineandortho.com
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasalyn Bennekin
Email
jb3043@georgetown.edu
Facility Name
St. Vincent's Neurosurgery
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cabria Darby
Email
cabria.darby@ascension.org
First Name & Middle Initial & Last Name & Degree
Kent New, MD
Facility Name
Kennedy-White Orthopaedic Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Wood, RN
Email
swood@kwoc.net
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mason Oliver
Email
masonoliver@usf.edu
First Name & Middle Initial & Last Name & Degree
Thanh Tran
Email
tqtran@usf.edu
Facility Name
Florida Orthopaedic Institute
City
Temple Terrace
State/Province
Florida
ZIP/Postal Code
33637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debbi Warren, RN, CCRC
Email
dwarren@foreonline.org
Facility Name
Legacy Brain and Spine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wes Williams
Email
wwilliams@legacybrainspine.com
Facility Name
Indiana Spine Group
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheetal Vinayek
Email
svinayek@indianaspinegroup.com
First Name & Middle Initial & Last Name & Degree
Jessica Rodenbeck
Email
jrodenbeck@indianaspinegroup.com
Facility Name
Orthopaedic Institute of Western Kentucky
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Vinson
Email
rvinson@oiwky.com
Facility Name
Spine Institute of Louisiana
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcus Stone, PhD
Email
mstone@louisianaspine.org
First Name & Middle Initial & Last Name & Degree
Heather Bowman
Email
hbowman@louisianaspine.org
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tyler Pease, MD
Email
tpease@som.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Ryan Smith
Email
ryan.smith@som.umaryland.edu
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Watterworth, RN
Email
Courtney.Watterworth@beaumont.org
Facility Name
Las Vegas Neurosurgical Institute for Spine and Brain Surgery
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University Spine Center
City
Wayne
State/Province
New Jersey
ZIP/Postal Code
07470
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
NYU Langone Orthopedic Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis Bellafiore
Email
Alexis.Bellafiore@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Connie Maglaras
Email
Constance.Maglaras@nyulangone.org
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Paschal
Email
paschalp@HSS.EDU
Facility Name
Northwell Health, Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danny Bass
Email
rbass1@northwell.edu
First Name & Middle Initial & Last Name & Degree
Hamna Muzammil
Email
hmuzammil@northwell.edu
Facility Name
Axis Neurosurgery and Spine
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Beang, PA
Email
Jbeang@axisneurosurgery.com
Facility Name
M3-Emerging Medical Resarch
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shandelle Parker
Email
sparker@wakeresearch.com
Facility Name
Beachwood Medical Center
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jayson Zadzilka, MS
Email
jzbiomedical@gmail.com
Facility Name
St. Vincent Charity Medical Group
City
Solon
State/Province
Ohio
ZIP/Postal Code
44139
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivia Christman
Email
ochristman@pennstatehealth.psu.edu
Facility Name
DFW Center for Spinal Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Keswani
Email
robin@researchtex.com
Facility Name
Texas Back Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Rusch, CCRC
Email
srusch@texasback.com
Facility Name
Texas Spine Care Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Keswani
Email
robin@researchtex.com
Facility Name
The Disc Replacement Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff Devaney, NP
Email
jeff.devaney@steward.org
First Name & Middle Initial & Last Name & Degree
Matt Allred, APRN, MSN
Email
mrallredrn@gmail.com
Facility Name
Multicare Neurosurgery and Spine
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheri Somers
Email
Cheri.Somers@multicare.org
First Name & Middle Initial & Last Name & Degree
Mirna Tohmeh
Email
Mirna.Tohmeh@multicare.org
12. IPD Sharing Statement
Plan to Share IPD
No
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2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
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