What side effects are associated with this type of intervention?

Common treatments for Cervical Spondylosis that involve structural support and spinal fusion, such as anterior cervical discectomy and fusion (ACDF), can have several side effects. These may include difficulty swallowing (dysphagia), hoarseness, nerve damage, infection, and issues related to the hardware used, such as plate or screw loosening. Additionally, there is a risk of non-union where the bones do not fuse properly, which may require further surgical intervention.

What prior FDA approvals exist?

FDA-approved treatments for Cervical Spondylosis that focus on structural support and promotion of spinal fusion include devices used in anterior cervical discectomy and fusion (ACDF) procedures. These treatments often involve the use of interbody cages and spinal plates to provide stability and promote bone fusion. Examples of such devices include the PEEK (polyetheretherketone) cages, titanium cages, and various types of cervical plates. These devices are designed to maintain proper spinal alignment, support the vertebrae, and facilitate the fusion of the cervical spine, similar to the CEM-Cage and CEM-Plate being studied in the trial.

What other types of research exist?

Promising novel alternatives to CEM-Cage and CEM-Plate for cervical spondylosis patients include: 1) 3D-printed titanium cages, which offer customized fit and enhanced osseointegration; 2) PEEK (polyetheretherketone) cages with surface modifications to improve bone growth; 3) Zero-profile devices that reduce the risk of adjacent level disease; and 4) Bioactive glass or ceramic implants that promote bone healing and fusion. These alternatives are designed to improve patient outcomes through better structural support and enhanced biological integration.

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Orthopedic Device

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

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.

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months.

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.

0 / 20Eligibility criteria met

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.