390 Participants Needed

Prodisc C SK & Vivo vs. Mobi-C for Cervical Disc Disease

(SMART Trial)

Recruiting at 37 trial locations
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Overseen ByBrooks Osburn, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, if you are taking medications that interfere with bone or soft tissue healing, like high-dose steroids, immunosuppressants, or chemotherapy agents, you may not be eligible to participate.

What safety data exists for Prodisc C and Mobi-C in treating cervical disc disease?

The safety data for Prodisc C and Mobi-C in treating cervical disc disease includes several studies. One study analyzed segmental cervical spine vertebral motion after Prodisc-C replacement, indicating it was part of an FDA trial. Another study presented a two-year follow-up on patients with a mobile ProDisc-C implant, suggesting it as an alternative to cervical spine fusion. Additionally, a study evaluated the effectiveness of single segmental cervical disc replacement with ProDisc-C, focusing on changes in the center of rotation. For Mobi-C, a study examined its use in cervical hybrid surgery, observing changes in the center of rotation and anterior bone loss. Another study investigated the clinical effectiveness of Mobi-C for cervical spondylotic radiculopathy. These studies provide insights into the safety and efficacy of these treatments.12345

Is the treatment Prodisc C SK, Prodisc C Vivo a promising treatment for Cervical Disc Disease?

Yes, Prodisc C SK and Prodisc C Vivo are promising treatments for Cervical Disc Disease. They are designed to replace damaged discs in the neck, helping to maintain movement and reduce pain, which can improve the quality of life for patients.12367

What data supports the idea that Prodisc C SK & Vivo vs. Mobi-C for Cervical Disc Disease is an effective treatment?

The available research shows that both Prodisc C and Mobi-C are effective treatments for cervical disc disease. Studies have shown that Mobi-C is effective for treating cervical spondylotic radiculopathy and single-level cervical disc spondylosis, with positive outcomes when compared to traditional surgery methods like anterior cervical disc fusion (ACDF). Similarly, Prodisc-C has shown good long-term results in treating cervical spondylosis, with studies indicating positive clinical outcomes over a 10-year follow-up period. These findings suggest that both treatments can be effective options for managing cervical disc disease.23789

Who Is on the Research Team?

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James Kuras

Principal Investigator

Centinel Spine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have nerve pain or weakness in my neck affecting my arms or hands.
My symptoms match the findings on my imaging tests.
I have neck pain due to issues in my cervical spine at two levels between C3 and C7.
See 3 more

Exclusion Criteria

I have had a serious neck injury between the C3 and C7 vertebrae.
I am not on high-dose steroids, immunosuppressants, or chemotherapy drugs.
Have a Body Mass Index (BMI) > 40 kg/m2
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the two-level prodisc C SK or prodisc C Vivo device, or the two-level Mobi-C device

Immediate post-surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including subject questionnaires, X-rays, and neurological assessments

24 months
Regular visits as specified in the protocol

Long-term follow-up

Participants continue to be monitored for up to 5 years to assess long-term safety and effectiveness

Additional 36 months

What Are the Treatments Tested in This Trial?

Interventions

  • Mobi-C Cervical Disc
  • prodisc C SK
  • prodisc C Vivo
Trial Overview 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.
How Is the Trial Designed?
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

prodisc C SK is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as prodisc C SK for:
  • Symptomatic cervical disc disease (SCDD)
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Approved in European Union as prodisc C SK for:
  • Symptomatic cervical disc disease (SCDD)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centinel Spine

Lead Sponsor

Trials
2
Recruited
590+

Published Research Related to This Trial

Cervical arthroplasty using the Mobi-C prosthesis significantly improved clinical symptoms in patients with cervical spondylotic radiculopathy, with neck pain decreasing from an average of 4.6 to 2.0 and arm pain from 6.5 to 1.3 on the visual analogue scale after surgery.
The procedure also resulted in an increase in disc space height from 6.5 mm to 7.7 mm, while maintaining range of motion, although long-term follow-up and further studies are needed to confirm these findings and ensure proper patient selection.
[The application of cervical arthroplasty with Mobi-C for treatment of cervical spondylotic radiculopathy].Jin, DD., Yan, HB., Zhang, ZM., et al.[2018]
The Mobi-C implant demonstrated a significantly lower incidence of further surgeries compared to anterior cervical disc fusion (ACDF), with only 1 out of 51 Mobi-C patients requiring re-operation versus 7 out of 48 ACDF patients.
Both Mobi-C and ACDF surgeries effectively improved clinical symptoms in patients with cervical disc degeneration, but the Mobi-C implant allowed for greater range of motion in the treated segment, indicating it may offer functional advantages.
Effectiveness and safety of Mobi-C for treatment of single-level cervical disc spondylosis: a randomised control trial with a minimum of five years of follow-up.Hou, Y., Nie, L., Pan, X., et al.[2022]
In a study of 42 patients undergoing cervical hybrid surgery with Mobi-C, significant improvements were observed in clinical outcomes such as the modified Japanese Orthopaedic Association (mJOA) score, Neck Disability Index (NDI), and visual analogue scale (VAS) scores post-surgery, indicating the efficacy of the intervention.
While there was some mild to moderate anterior bone loss (ABL) observed in the Mobi-C segments, no severe ABL occurred, and the changes in the flexion-extension center of rotation (FE-COR) did not negatively impact clinical outcomes, suggesting that Mobi-C is a safe option for cervical disc replacement.
Changes in the centre of rotation and the anterior bone loss of the vertebral body in Mobi-C artificial disc replacement segments after cervical hybrid surgery: a retrospective study.Ma, Y., Yu, X., Li, C., et al.[2023]

Citations

[The application of cervical arthroplasty with Mobi-C for treatment of cervical spondylotic radiculopathy]. [2018]
Effectiveness and safety of Mobi-C for treatment of single-level cervical disc spondylosis: a randomised control trial with a minimum of five years of follow-up. [2022]
Changes in the centre of rotation and the anterior bone loss of the vertebral body in Mobi-C artificial disc replacement segments after cervical hybrid surgery: a retrospective study. [2023]
[Clinical outcome of mid-term follow-up of anterior cervical non-fusion surgery versus anterior cervical discectomy and fusion for cervical spondylosis]. [2018]
Single-level cervical arthroplasty with ProDisc-C artificial disc: 10-year follow-up results in one centre. [2021]
6.Czech Republicpubmed.ncbi.nlm.nih.gov
[ProDisc-C mobile replacement of an intervertebral disc. A prospective mono-centric two-year study]. [2022]
Analysis of segmental cervical spine vertebral motion after prodisc-C cervical disc replacement. [2022]
[LOCATION CHANGE OF ROTATION CENTER AFTER SINGLE SEGMENTAL CERVICAL DISC REPLACEMENT WITH ProDisc-C]. [2018]
[Case control study on Mobi-C cervical artificial disc replacement and anterior cervical decompression MC+fusion for the treatment of cervical spondylosis]. [2019]
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