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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of two new devices, the CEM-Plate and CEM-Cage, for individuals with specific neck problems. It focuses on those with symptoms from cervical disc disorders affecting two connected neck areas. The trial targets individuals who have not improved with other treatments over at least six weeks and experience issues like nerve pain or spinal cord compression. Participants will undergo surgery and be monitored over two years to assess recovery and symptoms. Eligible participants should have neck pain due to cervical spine issues unresponsive to other treatments. As an unphased trial, this study offers an opportunity to contribute to medical research and potentially benefit from innovative treatments.

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 prior data suggests that these devices are safe for cervical disc disorder?

Research on devices like the CEM-Plate and CEM-Cage, used in spine surgeries, has shown they are generally safe. Similar devices, such as cervical plates and cage systems, have demonstrated a good safety record.

In one study, 48 side effects were reported, which are common in spine surgeries and not unexpected. While side effects can occur, they are usually manageable and not serious.

Since this is the first time the treatment is being tested on people, the main goal is to determine its safety for humans. Although data is limited, the good tolerance of similar devices provides some confidence in the safety of the CEM-Plate and CEM-Cage. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CEM-Plate and CEM-Cage devices because they offer a new approach to treating cervical disc disorders. Unlike traditional methods like standalone anterior cervical discectomy and fusion (ACDF) procedures, these devices integrate a specialized anterior cervical plating system with a cervical interbody system. This combination aims to provide better stability and fusion results. The innovative design could potentially lead to faster recovery times and improved patient outcomes, making it a promising alternative to existing treatment options.

What evidence suggests that the CEM-Plate and CEM-Cage devices are effective for cervical disc disorder?

Studies have shown that the CEM-Plate and CEM-Cage devices can stabilize the spine in patients undergoing anterior cervical discectomy and fusion (ACDF). This stability is crucial for proper healing and maintaining neck strength. Research indicates that using both a plate and a cage, such as the CEM-Plate and CEM-Cage, leads to better outcomes than using a cage alone. Results from similar devices in the past suggest that this combination might enhance recovery and reduce neck pain. Initial findings suggest these devices effectively support the neck and improve overall function after surgery. ^{1 2 3 4 5}

Who Is on the Research Team?

John German, MD

Principal Investigator

Albany Medical College

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. withpower.com withpower.com/trial/phase-bone-marrow-diseases-9-2021-958bc

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

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04883411/cem-plate-and-cem-cage-first-in-human-use-efficacy-study

CEM-Plate and CEM-Cage First-In-Human Use Efficacy ... The study is a prospective, first-in-human, multi-center, non-randomized, single-arm study to assess the safety and efficacy of the CEM-Cage ...

3. clinicaltrial.be clinicaltrial.be/fr/details/44066?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

CEM-Plate and CEM-Cage First-In-Human Use Efficacy ... The study is a prospective, first-in-human, multi-center, non-randomized, single-arm study to assess the safety and efficacy of the CEM-Cage ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11892192/

A retrospective comparative analysis of anterior cervical ... This study aims to compare the outcomes of two-level anterior cervical discectomy and fusion (ACDF) procedures using stand-alone cages versus cage and plate ...

5. app.trialscreen.org app.trialscreen.org/trials/neck-pain-cem-plate-cage-first-human-use-efficacy-trial-nct04883411

First-in-Human Study of CEM-Cage and CEM-Plate Participation in this study may provide potential benefits from the use of the CEM-Cage and CEM-Plate devices in treating cervical spine conditions requiring ...