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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.
Must not have
Have previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury
Have osteoporosis or is at increased risk of osteoporosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have nerve pain or weakness in my neck affecting my arms or hands.
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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.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a serious neck injury between the C3 and C7 vertebrae.
Select...
I have osteoporosis or am at high risk for it.
Select...
I have had a previous surgery on my neck for disc replacement or fusion.
Select...
I have more than one fused neck vertebra.
Select...
I have an autoimmune disease like rheumatoid arthritis or lupus.
Select...
I need daily high-dose steroids for another health condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 • NCT01801735
6%
Urinary tract infection
6%
Arthralgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Meloxicam 10 mg

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

prodisc C SK (Artificial Disc Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT04012996 — N/A
Cervical Disc Disease Research Study Groups: Investigational, Control
Cervical Disc Disease Clinical Trial 2023: prodisc C SK Highlights & Side Effects. Trial Name: NCT04012996 — N/A
prodisc C SK (Artificial Disc Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04012996 — N/A
~64 spots leftby Sep 2025
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