Status:
RECRUITING
CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study
Lead Sponsor:
ReVivo Medical, Corp.
Collaborating Sponsors:
Albany Medical College
The Cleveland Clinic
Conditions:
Neck Pain
Spondylosis
Eligibility:
All Genders
22-79 years
Phase:
NA
Brief Summary
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 can...
Detailed Description
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 can...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count.
- Suspected or documented metal allergy or intolerance.
- Inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition.
- Any patient unwilling to cooperate with the post-operative instructions.
- Any time implant utilization would interfere with anatomical structures or expected physiological performance.
Key Trial Info
Start Date :
March 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04883411
Start Date
March 7 2022
End Date
December 1 2027
Last Update
April 18 2025
Active Locations (4)
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1
IGEA
Union, New Jersey, United States, 07083
2
Albany Medical College
Albany, New York, United States, 12208
3
University at Buffalo Neurosurgery
Williamsville, New York, United States, 14221
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195