Symptomatic Cervical Disc DiseaseSMARTNCT04012996
2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
A study testing prodisc C SK and/or Vivo and Mobi-C Cervical Disc in people with Symptomatic Cervical Disc Disease, run by Centinel Spine at 30 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Cervical Disc Disease
- What is being tested?
- prodisc C SK and/or Vivo and Mobi-C Cervical Disc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 30 sitesUnited States
- Study dates
- 5 Aug 2019to 13 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 11Show fewer
- 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).
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
SVCMC Solon Medical - Northern Ohio Surgery Center
Beachwood, Ohio, 44122
Todd Lanman, MD, Inc.
Beverly Hills, California, 90210
Indiana Spine Group
Carmel, Indiana, 46032
M3-Emerging Medical Resarch
Durham, North Carolina, 27704
Flagstaff Bone and Joint
Flagstaff, Arizona, 86001
DFW Center for Spinal Disorders
Fort Worth, Texas, 76132
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
St. Vincent's Neurosurgery
Jacksonville, Florida, 32204
HCA Healthcare
Lone Tree, Colorado, 80124
Sky Ridge Medical Center Campus
Lone Tree, Colorado, 80124
Doctors Outpatient Center for Surgery
Los Angeles, California, 90048
NYU Langone Orthopedic Hospital
New York, New York, 10003
Hospital for Special Surgery
New York, New York, 10021
Northwell Health, Lenox Hill Hospital
New York, New York, 10075
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42003
Sutter Health - Palo Alto Medical Foundation
Palo Alto, California, 94301
Texas Back Institute
Plano, Texas, 75093
William Beaumont Hospital
Royal Oak, Michigan, 48073
Sutter Health
Sacramento, California, 95816
The Disc Replacement Center
Salt Lake City, Utah, 84088
Texas Spine Care Center
San Antonio, Texas, 78231
Kennedy-White Orthopaedic Center
Sarasota, Florida, 34232
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
University of South Florida
Tampa, Florida, 33606
Florida Orthopaedic Institute
Temple Terrace, Florida, 33637
Center for Spine and Orthopedics, Scientific Education and Research Foundation
Thornton, Colorado, 80229
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
University Spine Center
Wayne, New Jersey, 07470
Axis Neurosurgery and Spine
Williamsville, New York, 14221
About this study
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)
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).
Read the 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.
- Conditions
- Symptomatic Cervical Disc Disease
- Being tested
- prodisc C SK and/or Vivo, Mobi-C Cervical Disc
- 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
- Medical subject headings
- Neck Pain, Radiculopathy, Spinal Cord Diseases, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prodisc C SK and/or VivoDevice
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).
Mobi-C Cervical DiscDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | Two-level prodisc C SK and/or prodisc C Vivo Receives: Device: prodisc C SK and/or Vivo |
| Control | Active comparator | Two-level Mobi-C device Receives: Device: Mobi-C Cervical Disc |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start5 Aug 2019
- Primary completion31 Aug 2025 (estimated)
- Study completion13 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Cervical Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multi-center, prospective, randomized, controlled comparison
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centinel Spine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Kuras, Study director, Centinel Spine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012996
- Sponsor's protocol ID
- VAL-P-0022
- Acronym
- SMART
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2019
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04012996
- Acronym / sponsor ID
- SMART / VAL-P-0022
- Conditions
- Symptomatic Cervical Disc Disease
- Keywords
- symptomatic cervical disc disease, SCDD, neck pain, radiculopathy, myelopathy, cervical spine pain, neck surgery, cervical surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Centinel SpineIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 13 May 2028 (estimated)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- multi-center, prospective, randomized, controlled comparison
| Arm | Type | Receives |
|---|---|---|
| Investigational | Experimental | Device: prodisc C SK and/or VivoTwo-level prodisc C SK and/or prodisc C Vivo |
| Control | Active comparator | Device: Mobi-C Cervical DiscTwo-level Mobi-C device |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prodisc C SK and/or VivoSubjects 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). | Device | Investigational |
| Mobi-C Cervical DiscSubjects 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). | Device | Control |
Primary outcome
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)
Time frame: 24 months
Includes assessments such as NDI and neurological improvement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Kuras study director
Centinel Spine
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prodisc C SK and/or Vivo and Mobi-C Cervical Disc in people with Symptomatic Cervical Disc Disease, run by Centinel Spine at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.