CEM-Plate and CEM-Cage Devices for Cervical Disc Disorder

Recruiting at 3 trial locations

Overseen By Eric H Ledet, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ReVivo Medical, Corp.

Must not be taking: High-dose steroids

Disqualifiers: Osteoporosis, Active malignancy, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests the safety and effectiveness of the CEM-Cage and CEM-Plate in patients needing a specific neck surgery. These devices help stabilize and fuse neck bones after damaged discs are removed. The study will monitor patients for an extended period to ensure successful healing and device performance.

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

The trial information does not specify if you need to stop taking your current medications. However, if you are on high-dose steroids or investigational drugs, you may not be eligible to participate.

What data supports the effectiveness of the CEM-Plate and CEM-Cage treatment for cervical disc disorder?

Research on similar treatments, like cage-and-plate constructs, shows they are effective for stabilizing the cervical spine and restoring disc height in cervical disc disease. These treatments are commonly used and have been shown to help with conditions requiring cervical decompression and stabilization. ^{1 2 3 4 5}

Is the CEM-Plate and CEM-Cage treatment safe for humans?

Research on similar devices, like cervical plates and cage systems used in spine surgeries, shows that they are generally safe. In one study, 48 adverse events were reported, but none were linked to the device itself, suggesting that these types of devices are typically safe for human use. ^{1 3 6 7 8}

How is the CEM-Plate and CEM-Cage treatment for cervical disc disorder different from other treatments?

The CEM-Plate and CEM-Cage treatment is unique because it combines a plate and cage for cervical spine stabilization, which is designed to restore disc height and provide stability. This approach may differ from other treatments like artificial discs or zero-profile constructs, which focus on maintaining range of motion and minimizing impact on adjacent disc spaces. ^{1 2 4 5 9}

Research Team

John German, MD

Principal Investigator

Albany Medical College

Eligibility Criteria

This trial is for adults aged 22-79 with neck pain and spinal issues due to cervical disc disorder, who haven't improved after 6 weeks of non-surgical treatment. Candidates must have specific scores on NDI or mJOA scales, confirmed symptoms by imaging, and be able to consent. Exclusions include prior cervical surgeries at the affected levels, certain bone diseases, severe instability or infection in the spine area, high-dose steroid use, substance abuse history, pregnancy, metal allergies and a BMI over 40.

Inclusion Criteria

I have been diagnosed with nerve or spinal cord issues in my neck.

Ability to speak, read, and understand the IRB approved Informed Consent document.

Willingness to give informed consent for participation in the study.

Exclusion Criteria

I have a fever.

I have neck pain without any nerve or spinal cord issues needing surgery.

Mental illness that, in the opinion of the investigator, would preclude patient's ability to participate in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Participants undergo a 2-level anterior cervical discectomy and fusion (ACDF) with the CEM-Cage and CEM-Plate

Post-operative Evaluation

Participants are evaluated at 4 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months post-operatively. Quality of life scales and adverse events are collected. Radiographs are used to assess implant positioning, integrity, and fusion.

24 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CEM-Plate and CEM-Cage

Trial Overview The study tests the safety and effectiveness of CEM-Cage with CEM-Plate in patients needing a two-level anterior cervical discectomy and fusion (ACDF). Fifty participants will undergo ACDF using these devices and will be monitored regularly up to two years post-operation.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Two-Level ACDF with CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System.

Who Is Running the Clinical Trial?

ReVivo Medical, Corp.

Lead Sponsor

Trials

1

Recruited

50+

Albany Medical College

Collaborator

Trials

96

Recruited

12,700+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

IGEA

Industry Sponsor

Trials

6

Recruited

170+

Findings from Research

The Perfect-C implant demonstrated significant advantages in surgical efficiency, with shorter operation times, reduced blood loss, and shorter hospital stays compared to both the Zero-P implant and the titanium plate with PEEK cage in a study of 148 patients undergoing ACDF.

The Perfect-C and Zero-P groups showed no cases of heterotopic ossification, while the plate-with-cage group had a 30% occurrence, indicating a potential safety benefit of the Perfect-C implant in preventing this complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison among perfect-C®, zero-P®, and plates with a cage in single-level cervical degenerative disc disease. Noh, SH., Zhang, HY.[2018]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Cervical spine stabilization by plate-cage. Clinical evaluation. [2016]

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

Comparison among perfect-C®, zero-P®, and plates with a cage in single-level cervical degenerative disc disease. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Changes in cervical alignment of Zero-profile device versus conventional cage-plate construct after anterior cervical discectomy and fusion: a meta-analysis. [2022]

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

Outcomes following 2-level cervical interventions with cage-and-plate, zero-profile, or arthroplasty constructs. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of cervical zero profile integrated cage with and without supplemental posterior Interfacet stabilization. [2021]

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

Follow-up of a new titanium cervical plate for fusion of the cervical spine. [2023]

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

The use of carbon fiber cages in anterior cervical interbody fusion: report of 100 cases. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Application of a new integrated low-profile anterior plate and cage system in single-level cervical spondylosis: a preliminary retrospective study. [2022]

9. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

The use of a hollow polymethylmethacrylate cervical spacer with plating in the treatment of single level cervical disc disease. [2013]