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

Launched by REVIVO MEDICAL, CORP. · May 11, 2021

Keywords

ClinConnect Summary

The CEM-Plate and CEM-Cage study is a clinical trial designed to test a new medical device for patients suffering from neck pain and related issues, such as spondylosis (a condition that affects the spine) and nerve problems. This trial will involve 50 patients who are suitable candidates for a specific type of surgery known as anterior cervical discectomy and fusion (ACDF), which aims to relieve symptoms by removing a damaged disc and fusing two vertebrae together. Participants will have the surgery and then be monitored for their recovery at various intervals over two years to see how well the device works and if it is safe.

To be eligible, participants must be between the ages of 22 and 79 and have specific symptoms related to their neck issues that haven’t improved with other treatments for at least six weeks. They also need to have certain test results that show their condition is serious enough to require surgery. During the trial, participants can expect regular follow-ups with doctors to assess their progress and any side effects. It’s important to note that certain health conditions, previous surgeries, or specific anatomical issues may disqualify someone from participating in this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males and females aged 22-79 years.
• • 2. Documented diagnosis of cervical spine radiculopathy or myelopathy.
• • 3. Symptomatic cervical degenerative disc disease at 2 contiguous levels between C2 through T1.
• • 4. Baseline NDI score ≥30 and/or baseline mJOA score ≤16.
• • 5. 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).
• • 6. 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.
• • 7. Ability to speak, read, and understand the IRB approved Informed Consent document.
• • 8. Willingness to give informed consent for participation in the study.
• Exclusion Criteria:
• • 1. Any prior cervical surgeries at the symptomatic levels; prior surgery or cervical fusion procedure at any level.
• • 2. Fewer than 2 or more than 2 vertebral levels requiring treatment.
• • 3. Anatomy that is non-conducive to receiving investigational device.
• • 4. 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.
• • 5. 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.
• • 6. Paget disease, osteomalacia, or any other metabolic bone disease other than osteoporosis.
• • 7. 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.
• • 8. Severe cervical instability based on radiographic exam (whereby an anterior and posterior reconstructive procedure is indicated).
• • 9. Decompression requiring corpectomy at one or more levels.
• • 10. Active systemic infection or an infection localized to the site of the proposed implantation.
• • 11. Open wounds.
• • 12. Signs of local inflammation.
• • 13. Fever.
• • 14. Any diseases or conditions that would preclude accurate clinical evaluation.
• • 15. Daily, high-dose oral and/or inhaled steroids or a history of chronic use of high-dose steroids.
• • 16. BMI \> 40.
• • 17. Use of any other investigational drug or medical device within 30 days prior to surgery.
• • 18. Smoking more than 1 pack of cigarettes/day.
• • 19. Mental illness that, in the opinion of the investigator, would preclude patient's ability to participate in the study.
• • 20. Current or recent history of substance abuse (alcoholism and/or narcotic addiction) requiring intervention.
• • 21. Litigation relating to spinal injury/worker's compensation.
• • 22. Reported to have a history of or anticipated treatment for active systemic infection, including human immunodeficiency virus (HIV) or Hepatitis C.
• • 23. Previous trauma to the C2 to T1 levels resulting in significant bony or disco-ligamentous cervical spine injury.
• • 24. Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy or myelopathy justifying the need for surgical intervention.
• • 25. Pregnancy.
• • 26. 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.
• • 27. Suspected or documented metal allergy or intolerance.
• • 28. Inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition.
• • 29. Any patient unwilling to cooperate with the post-operative instructions.
• • 30. Any time implant utilization would interfere with anatomical structures or expected physiological performance.