CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study

Recruiting now · Not applicable

Conditions studied: Neck Pain, Spondylosis, Spondylosis With Myelopathy, Spondylosis With Radiculopathy, Spondylosis With Radiculopathy Cervical Region, Intervertebral Disc Disorder Cervical

In brief

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 used with the CEM-Plate in patients who are appropriate candidates for a 2-level anterior cervical discectomy and fusion (ACDF). Fifty patients will be enrolled in the study and, after undergoing a 2-level ACDF, will be evaluated at 4 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.

Key facts

Study ID

NCT04883411

Run by

ReVivo Medical, Corp.

People needed

50

Starts

2022-03-07

Expected to finish

2027-12-01

Last updated by the study team

2025-04-18

Who can join

Age: 22 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females aged 22-79 years.
• Documented diagnosis of cervical spine radiculopathy or myelopathy.
• Symptomatic cervical degenerative disc disease at 2 contiguous levels between C2 through T1.
• Baseline NDI score ≥30 and/or baseline mJOA score ≤16.
• Pathology at the level to be treated correlating to the primary symptoms confirmed by imaging (computed tomography (CT), CT myelography, magnetic resonance imaging (MRI), or plain radiography).
• Unresponsive to non-operative, conservative treatment for at least 6 weeks from symptom onset or presence of progressive cervical myelopathy or signs of nerve root/spinal cord compression despite continued non-operative treatment.
• Ability to speak, read, and understand the IRB approved Informed Consent document.
• Willingness to give informed consent for participation in the study.

You may not qualify if…

• Any prior cervical surgeries at the symptomatic levels; prior surgery or cervical fusion procedure at any level.
• Fewer than 2 or more than 2 vertebral levels requiring treatment.
• Anatomy that is non-conducive to receiving investigational device.
• 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.
• Known diagnosis of osteoporosis, current pharmacological treatment for osteoporosis or bone density which in the medical opinion of the surgeon precludes operation or contraindicates instrumentation.
• Paget disease, osteomalacia, or any other metabolic bone disease other than osteoporosis.
• Active malignancy that includes a history of any invasive malignancy (except nonmelanoma skin cancer), unless previously treated with curative intent and with no clinical signs or symptoms of the malignancy for > 5 years.
• Severe cervical instability based on radiographic exam (whereby an anterior and posterior reconstructive procedure is indicated).
• Decompression requiring corpectomy at one or more levels.
• Active systemic infection or an infection localized to the site of the proposed implantation.
• Open wounds.
• Signs of local inflammation.
• Fever.
• Any diseases or conditions that would preclude accurate clinical evaluation.
• Daily, high-dose oral and/or inhaled steroids or a history of chronic use of high-dose steroids.
• BMI > 40.
• Use of any other investigational drug or medical device within 30 days prior to surgery.
• Smoking more than 1 pack of cigarettes/day.
• Mental illness that, in the opinion of the investigator, would preclude patient's ability to participate in the study.
• Current or recent history of substance abuse (alcoholism and/or narcotic addiction) requiring intervention.
• Litigation relating to spinal injury/worker's compensation.
• Reported to have a history of or anticipated treatment for active systemic infection, including human immunodeficiency virus (HIV) or Hepatitis C.
• Previous trauma to the C2 to T1 levels resulting in significant bony or disco-ligamentous cervical spine injury.
• Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy or myelopathy justifying the need for surgical intervention.
• Pregnancy.

Where it is running

• IGEA — Union, New Jersey, United States (enrolling)
• Albany Medical College — Albany, New York, United States (enrolling)
• University at Buffalo Neurosurgery — Williamsville, New York, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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