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

(SMART Trial)

Recruiting in Palo Alto (17 mi)

+37 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Centinel Spine

Must not be taking: Steroids, Immunosuppressants, Chemotherapy

Disqualifiers: Osteoporosis, Autoimmune diseases, Obesity, others

No Placebo Group

Trial Summary

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 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.

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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.

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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.

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Eligibility Criteria

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.

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

Trial Timeline

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

Participant Groups

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.

Group I: Investigational Experimental Treatment 1 Intervention

Two-level prodisc C SK and/or prodisc C Vivo

Group II: Control Active Control 1 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)

🇪🇺 Approved in European Union as prodisc C SK for:

• Symptomatic cervical disc disease (SCDD)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Las Vegas Neurosurgical Institute for Spine and Brain Surgery Las Vegas, NV

Indiana Spine Group Carmel, IN

Northwell Health Lenox Hill Hospital New York, NY

Texas Spine Care San Antonio, TX

More Trial Locations

Who Is Running the Clinical Trial?

Centinel Spine Lead Sponsor

References

1. China pubmed.ncbi.nlm.nih.gov

[The application of cervical arthroplasty with Mobi-C for treatment of cervical spondylotic radiculopathy]. [2018] To investigate the clinical effectiveness of cervical arthroplasty with Mobi-C prosthesis for treatment of cervical spondylotic radiculopathy.

2. England pubmed.ncbi.nlm.nih.gov

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] In order to evaluate the effectiveness of the Mobi-C implant in cervical disc degeneration, a randomised study was conducted, comparing the Mobi-C prosthesis arthroplasty with anterior cervical disc fusion (ACDF) in patients with single level cervical spondylosis.

3. Germany pubmed.ncbi.nlm.nih.gov

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] To examine the short-term efficacy and imaging results of using the Mobi-C in cervical hybrid surgery on 2-level cervical spondylolisthesis. To observe post-operative changes in the flexion-extension centre of rotation (FE-COR) and anterior bone loss (ABL) of the anterior cervical disc replacement (ACDR) segment.

4. China pubmed.ncbi.nlm.nih.gov

[Clinical outcome of mid-term follow-up of anterior cervical non-fusion surgery versus anterior cervical discectomy and fusion for cervical spondylosis]. [2018] To evaluate the clinical and radiological outcomes of artificial cervical disc replacement (Prodisc-C), dynamic cervical implant and anterior cervical discectomy and fusion (ACDF) in the treatment of cervical spondylosis.

5. Germany pubmed.ncbi.nlm.nih.gov

Single-level cervical arthroplasty with ProDisc-C artificial disc: 10-year follow-up results in one centre. [2021] The aim of this study was to evaluate the long-term clinical and radiographic outcomes of cervical arthroplasty using the ProDisc-C prosthesis.

6. United States pubmed.ncbi.nlm.nih.gov

Analysis of segmental cervical spine vertebral motion after prodisc-C cervical disc replacement. [2022] Retrospective study of patients enrolled in a prospective randomized Food and Drug Administration trial with single level cervical disc replacement (CDR) with the ProDisc-C (Synthes, Paoli, PA).

7. Czech Republic pubmed.ncbi.nlm.nih.gov

[ProDisc-C mobile replacement of an intervertebral disc. A prospective mono-centric two-year study]. [2022] To present the results of an independent mono-centric prospective study on patients with a mobile ProDisc-C implant. This cervical artificial disc replacement (CADR), which is one of the options for avoiding cervical spine fusion, was evaluated during two-years follow-up.

8. China pubmed.ncbi.nlm.nih.gov

[LOCATION CHANGE OF ROTATION CENTER AFTER SINGLE SEGMENTAL CERVICAL DISC REPLACEMENT WITH ProDisc-C]. [2018] To evaluate the effectiveness of the single segmental cervical disc replacement with ProDisc-C, and to explore the location change of the flexion/extension center of rotation (COR) of the target level as well as its clinical significance.

9. China pubmed.ncbi.nlm.nih.gov

[Case control study on Mobi-C cervical artificial disc replacement and anterior cervical decompression MC+fusion for the treatment of cervical spondylosis]. [2019] To compare the clinical effects and clinical indications between Mobi-C cervical artificial disc replacement (CADR) and MC+ anterior cervical decompression and fusion(ACDF) in treating cervical spondylosis.