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Orthopedic Device

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

Williamsville, NY
N/A
Recruiting
Led By James Lawrence, MD
Research Sponsored by ReVivo Medical, Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented diagnosis of cervical spine radiculopathy or myelopathy.
Baseline NDI score ≥30 and/or baseline mJOA score ≤16.
Must not have
Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy or myelopathy justifying the need for surgical intervention.
More than one immobile vertebral level between C-1 to C-7 from any cause, including but not limited to congenital abnormalities and osteoarthritic 'spontaneous' fusions.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months.
Awards & highlights
No Placebo-Only Group

Summary

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.

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Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include typical surgical risks such as infection at the site of implantation, inflammation around the area where devices are placed; allergic reactions if there's an undiagnosed metal allergy; complications from anesthesia; nerve damage that could lead to pain or numbness; difficulty swallowing; bleeding or blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with nerve or spinal cord issues in my neck.
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My neck disability or arm function scores indicate significant impairment.
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I have neck pain due to disc problems in my spine from C2 to T1.
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My symptoms match the imaging results of my condition.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have neck pain without any nerve or spinal cord issues needing surgery.
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I have more than one fused spine bone in my neck from any cause.
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My neck is very unstable and needs surgery based on X-ray results.
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I have signs of swelling or redness.
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I have had a serious neck injury affecting my spine.
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I have poor tissue or bone quality at the surgery site.
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I have open wounds.
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I have or expect to be treated for an active infection like HIV or Hepatitis C.
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I do not have conditions that would make spinal implant surgery risky for me.
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I use high-dose steroids daily or have a history of doing so.
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I have had surgery to remove part of my spine.
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I have a bone condition that is not osteoporosis.
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I have had surgery on my neck at the level causing symptoms or any cervical fusion.
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I need treatment for either less than 2 or more than 2 of my spine levels.
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My body is not suitable for the trial device.
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I do not have any ongoing infections.
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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
Fusion
Secondary study objectives
Device-Related Adverse Events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Two-Level ACDF with CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Cervical Spondylosis, particularly those focusing on structural support and spinal fusion, aim to stabilize the cervical spine and alleviate pain by promoting bone growth between vertebrae. Devices like the CEM-Cage and CEM-Plate are used in procedures such as anterior cervical discectomy and fusion (ACDF), where they provide structural support and facilitate the fusion of adjacent vertebrae. This fusion helps to eliminate motion at the affected spinal segment, reducing nerve compression and pain. For patients, these treatments are crucial as they can significantly improve stability, reduce pain, and enhance overall quality of life by addressing the underlying structural issues in the cervical spine.

Find a Location

Closest Location:University at Buffalo Neurosurgery· Williamsville, NY

Who is running the clinical trial?

ReVivo Medical, Corp.Lead Sponsor
Albany Medical CollegeOTHER
95 Previous Clinical Trials
12,607 Total Patients Enrolled
The Cleveland ClinicOTHER
1,069 Previous Clinical Trials
1,376,948 Total Patients Enrolled
IGEAIndustry Sponsor
5 Previous Clinical Trials
120 Total Patients Enrolled
James Lawrence, MDPrincipal InvestigatorAlbany Medical College
1 Previous Clinical Trials
65 Total Patients Enrolled
John German, MDPrincipal InvestigatorAlbany Medical College

Media Library

CEM-Plate and CEM-Cage (Orthopedic Device) Clinical Trial Eligibility Overview. Trial Name: NCT04883411 — N/A
Cervical Spondylosis Research Study Groups: Treatment
Cervical Spondylosis Clinical Trial 2023: CEM-Plate and CEM-Cage Highlights & Side Effects. Trial Name: NCT04883411 — N/A
CEM-Plate and CEM-Cage (Orthopedic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04883411 — N/A
~12 spots leftby Mar 2026