First use of CEM-Plate and CEM-Cage for treating neck pain and related conditions

First-in-human Prospective Study to Assess the Safety and Efficacy of the CEM-Cage and CEM-Plate

This study is testing a new surgical device called CEM-Plate and CEM-Cage to see if it can safely help people with neck pain after a specific type of neck surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 22 Years to 79 Years
• Sex: All
• Sponsor: ReVivo Medical, Corp. (Industry-sponsored)
• Locations: 4 sites (Union, New Jersey and 3 other locations)
• Trial ID: NCT04883411 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the CEM-Cage and CEM-Plate in patients undergoing a two-level anterior cervical discectomy and fusion (ACDF). It is a prospective, first-in-human, multi-center, non-randomized, single-arm study involving 50 patients who will be monitored over a period of 24 months. Participants will undergo a surgical procedure followed by multiple post-operative evaluations to assess quality of life, adverse events, and fusion success through imaging techniques. The study aims to establish co-primary endpoints for fusion and overall success based on specific criteria.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 22-79 with documented cervical spine radiculopathy or myelopathy unresponsive to conservative treatment.

Not a fit: Patients who have had prior cervical surgeries at the symptomatic levels may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from cervical spondylosis and related conditions.

How similar studies have performed: While this approach is novel in its specific application, similar studies have shown success with cervical fusion techniques.

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.

Where this trial is running

Union, New Jersey and 3 other locations

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

Study contacts

• Principal investigator: John German, MD — Albany Medical College
• Study coordinator: Eric H Ledet, Ph.D.

Conditions Neck Pain; Spondylosis; Spondylosis With Myelopathy; Spondylosis With Radiculopathy; Spondylosis With Radiculopathy Cervical Region; Intervertebral Disc Disorder Cervical; Cervical Spondylosis; Cervical Myelopathy