Actively Recruiting
First-in-Human Prospective Study to Assess Safety and Efficacy of the CEM-Cage and CEM-Plate in Two-Level Anterior Cervical Discectomy and Fusion
Led by ReVivo Medical, Corp. · Updated on 2025-04-18
50
Participants Needed
4
Research Sites
17 weeks
Total Duration
On this page
Sponsors
R
ReVivo Medical, Corp.
Lead Sponsor
A
Albany Medical College
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of the CEM-Cage combined with the CEM-Plate in patients undergoing a two-level anterior cervical discectomy and fusion (ACDF). It is a first-in-human, prospective, multi-center, non-randomized, single-arm study involving fifty patients with cervical spine conditions such as radiculopathy or myelopathy. The study is designed to provide important information about the device's performance in treating cervical degenerative disc disease. Participants will undergo a two-level ACDF surgery using the CEM-Plate Anterior Cervical Plating System and the CEM-Cage Cervical Interbody System. After surgery, patients will have follow-up visits at 4 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months. These visits include assessments such as quality of life surveys and imaging tests like lateral cervical x-rays to check the device placement and spinal fusion progress. Throughout the study, researchers will monitor for fusion success and overall outcomes, including the absence of serious adverse events or need for additional surgeries at the treated levels. Safety and device-related complications will be tracked for up to 24 months. Participants' quality of life and spine function will be regularly evaluated, helping to understand the long-term effects of the device.
CONDITIONS
Brief Title
CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 22-79 years
- Documented diagnosis of cervical spine radiculopathy or myelopathy
- Symptomatic cervical degenerative disc disease at exactly 2 contiguous levels between C2 and T1
- Baseline Neck Disability Index (NDI) score of 30 or higher and/or baseline modified Japanese Orthopaedic Association (mJOA) score of 16 or lower
- Pathology at the treatment levels confirmed by imaging (CT, CT myelography, MRI, or x-ray)
- Symptoms unresponsive to non-surgical treatment for at least 6 weeks or progressive myelopathy or nerve root/spinal cord compression despite treatment
- Ability to read, understand, and provide informed consent
- Willingness to participate in the study
You will not qualify if you...
- Prior cervical surgery or fusion at symptomatic levels or any cervical level
- Fewer than or more than 2 vertebral levels requiring treatment
- Anatomy unsuitable for the investigational device
- More than one immobile vertebral level from any cause between C1 and C7
- Diagnosis or treatment for osteoporosis or other metabolic bone diseases excluding osteoporosis
- Active or recent invasive malignancy within 5 years except treated nonmelanoma skin cancer
- Severe cervical instability requiring anterior and posterior reconstruction
- Need for corpectomy decompression at one or more levels
- Active infections including systemic or local site infection
- Open wounds, local inflammation, or fever
- Conditions interfering with clinical evaluation
- Use of high-dose steroids daily or history of chronic high-dose steroid use
- Body mass index over 40
- Use of other investigational drugs or devices within 30 days prior to surgery
- Smoking more than one pack of cigarettes per day
- Mental illness impairing study participation
- Current or recent substance abuse requiring intervention
- Litigation related to spinal injury or worker's compensation
- History or anticipated treatment for active systemic infections such as HIV or Hepatitis C
- Significant cervical trauma from C2 to T1
- Axial neck pain without other symptoms requiring surgery
- Pregnancy
- Medical or surgical conditions precluding benefit from spinal implant surgery
- Known or suspected metal allergy or intolerance
- Inadequate tissue coverage or bone quality at the operative site
- Unwillingness to follow post-operative instructions
- Implant use interfering with anatomical structures or function
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants undergo screening to confirm eligibility based on medical history and imaging.
Duration - Day of surgery
Participants undergo a two-level anterior cervical discectomy and fusion using the CEM-Cage and CEM-Plate devices.
1 surgical procedure visit (in-person)
Duration - 24 months
Participants are monitored for recovery, implant positioning, and safety through scheduled follow-up visits. Quality of life scales and adverse events are collected at each visit.
6 post-operative visits at 4 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months
Trial Site Locations
Total: 4 locations
1
IGEA
Union, New Jersey, United States, 07083
Actively Recruiting
2
Albany Medical College
Albany, New York, United States, 12208
Actively Recruiting
3
University at Buffalo Neurosurgery
Williamsville, New York, United States, 14221
Actively Recruiting
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
E
Eric H Ledet, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here