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Artificial Disc Replacement
Prodisc C SK & Vivo vs. Mobi-C for Cervical Disc Disease (SMART Trial)
N/A
Recruiting
Research Sponsored by Centinel Spine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
SMART Trial Summary
This trial is testing two different types of disc replacements against a similar device that is already on the market.
Who is the study for?
This trial is for adults aged 18-69 with cervical disc disease causing neck pain, weakness, or numbness that hasn't improved with treatments like rest or physical therapy. It's not for those who are very overweight, have had certain spine surgeries before, smoke heavily, have osteoporosis, metal allergies, immobile spinal segments, autoimmune diseases affecting the musculoskeletal system or take medication that affects healing.Check my eligibility
What is being tested?
The study compares two types of artificial cervical discs (prodisc C SK and Vivo) against a similar approved device (Mobi-C). Participants will be randomly assigned to receive one of these devices in a surgery meant to alleviate symptoms from degenerative disc conditions in the neck.See study design
What are the potential side effects?
Potential side effects may include discomfort at the implant site, infection risk from surgery, allergic reactions to materials in the implants if sensitivity exists despite screening out known allergies during eligibility assessment and possible complications related to movement of the artificial disc.
SMART Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have nerve pain or weakness in my neck affecting my arms or hands.
Select...
My symptoms match the findings on my imaging tests.
Select...
I have neck pain due to issues in my cervical spine at two levels between C3 and C7.
Select...
I am between 18 and 69 years old.
Select...
I have nerve pain or weakness in my neck affecting my arms, due to issues between C3 and C7.
Select...
I am between 18 and 69 years old.
Select...
My symptoms match the findings on my imaging tests.
SMART Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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)
Side effects data
From 2014 Phase 3 trial • 600 Patients • NCT018017356%
Urinary tract infection
6%
Arthralgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Meloxicam 10 mg
SMART Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InvestigationalExperimental Treatment1 Intervention
Two-level prodisc C SK and/or prodisc C Vivo
Group II: ControlActive Control1 Intervention
Two-level Mobi-C device
Find a Location
Who is running the clinical trial?
Centinel SpineLead Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled
Leonard I Voronov, MD, PhDStudy DirectorCentinel Spine
James KurasStudy DirectorCentinel Spine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a serious neck injury between the C3 and C7 vertebrae.I have nerve pain or weakness in my neck affecting my arms or hands.My symptoms match the findings on my imaging tests.I am not on high-dose steroids, immunosuppressants, or chemotherapy drugs.I have neck pain due to issues in my cervical spine at two levels between C3 and C7.I've been cancer-free for 5 years, except for non-melanoma skin cancer.I have osteoporosis or am at high risk for it.I am between 18 and 69 years old.I have had a previous surgery on my neck for disc replacement or fusion.I have more than one fused neck vertebra.I have an autoimmune disease like rheumatoid arthritis or lupus.My condition did not improve with basic treatments like rest, heat, or painkillers.I have nerve pain or weakness in my neck affecting my arms, due to issues between C3 and C7.I am between 18 and 69 years old.My symptoms match the findings on my imaging tests.I need daily high-dose steroids for another health condition.You smoke a lot, more than a pack of cigarettes per day.
Research Study Groups:
This trial has the following groups:- Group 1: Investigational
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigation currently seeking participants?
"Data hosted on clinicaltrials.gov confirms that this experiment remains open for recruitment, having first been posted on August 5th 2019 and most recently updated October 27th 2022."
Answered by AI
What are the eligibility criteria for enrolment in this clinical trial?
"This clinical trial is seeking 390 individuals aged 18 to 69 that have been diagnosed with intervertebral disc displacement. Moreover, to be eligible for the study, these patients must have undergone a non-surgical course of treatment and present radiographic evidence of pathology at the symptomatic level in their cervical spine (C3 - C7)."
Answered by AI
Is eligibility contingent on a participant's age, such that those over 20 years are excluded?
"This experiment is open to individuals aged between 18 and 69. There are also two trials specifically for minors, as well as 91 studies that cater exclusively to seniors older than 65 years old."
Answered by AI
How many participants has the research accepted to date?
"Affirmative, clinicaltrials.gov states that this research is actively seeking volunteers. It was first published on August 5th 2019 and updated most recently on October 27th 2022. As of then, 390 participants had to be recruited from 36 different sites."
Answered by AI
Who else is applying?
What state do they live in?
California
Ohio
Nebraska
Other
How old are they?
18 - 65
What site did they apply to?
Flagstaff Bone and Joint
Doctors Outpatient Center for Surgery
Penn State Milton S. Hershey Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
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