Neck PainNCT04883411
CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study
A study testing CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System in people with Neck Pain and Spondylosis, run by ReVivo Medical, Corp. at 4 sites in United States.
Trial 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 candidates for a 2-level anterior cervical discectomy and fusion (ACDF). Read more about this study
- Who is it for?
- Ages 22 to 79 years
- Conditions the study is for
- Neck Pain, Spondylosis, Spondylosis With Myelopathy
- What is being tested?
- CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Mar 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 30Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Albany Medical College
Albany, New York, 12208
John German, MD, germanj@amc.edu
Darryl DiRisio, MD
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Dominic Pelle, MD
Michael Steinmetz, MD
- Recruiting
IGEA
Union, New Jersey, 07083
Adam Lipson, MD
Adam Lipson, MD
- Recruiting
University at Buffalo Neurosurgery
Williamsville, New York, 14221
John Pollina, MD
John Pollina, MD
About this study
Official title: First-in-human Prospective Study to Assess the Safety and Efficacy of the CEM-Cage and CEM-Plate
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.
Read the 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 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.
The study consists of a screening period, surgical procedure, and 6 post-operative visits. At each indicated visit, quality of life scales and adverse events will be collected. In addition, at 4 weeks post-operatively, patients will undergo static lateral cervical plain x rays to assess implant positioning and integrity. At 3 months, 6 months, 12 months, 18 months, and 24 months, patients will undergo flexion/extension and neutral lateral plain radiographs to assess overall success and fusion.
The study has co-primary endpoints for efficacy (fusion) and overall success where overall success is defined as fusion, device implanted as intended, no serious adverse events related to the surgical procedure, no device-related serious adverse events, no subsequent surgical interventions at the index levels, and absence of clinically significant device malfunctions. Fusion data will be compared to benchmark data (Davis et al, 2013, control arm of the 2-level Mobi-C IDE study).
- Conditions
- Neck Pain, Spondylosis, Spondylosis With Myelopathy, Spondylosis With Radiculopathy, Spondylosis With Radiculopathy Cervical Region, Intervertebral Disc Disorder Cervical
- Being tested
- CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System
- Keywords
- Cervical Spondylosis, Cervical Myelopathy, Cervical Radiculopathy, Neck Pain
- Medical subject headings
- Neck Pain, Spondylosis, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody SystemDevice
Two-Level ACDF with CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Two-Level ACDF with CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System. Receives: Device: CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion
Flexion-extension plain radiographs and CT scans will be used to assess bony fusion at both surgical levels.
Measured: 24 months.
Secondary outcomes (1)
Device-Related Adverse Events
No serious adverse events related to the surgical procedure, no device-related serious adverse events, no subsequent surgical interventions at the index levels, and absence of clinically significant device malfunctions.
Measured: 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start7 Mar 2022
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, first-in-human, multi-center, non-randomized, single arm study.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReVivo Medical, Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Albany Medical College, The Cleveland Clinic, IGEA
- Responsible party
- Sponsor
- Investigators
- John German, MD, Principal investigator, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883411
- Sponsor's protocol ID
- RM-21-001
- Status last verified
- Apr 2025
- First submitted
- 5 May 2021
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-human Prospective Study to Assess the Safety and Efficacy of the CEM-Cage and CEM-Plate
- ClinicalTrials.gov ID
- NCT04883411
- Acronym / sponsor ID
- RM-21-001
- Conditions
- Neck Pain, Spondylosis, Spondylosis With Myelopathy, Spondylosis With Radiculopathy, Spondylosis With Radiculopathy Cervical Region, Intervertebral Disc Disorder Cervical
- Keywords
- Cervical Spondylosis, Cervical Myelopathy, Cervical Radiculopathy, Neck Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- ReVivo Medical, Corp.Industry (pharma, biotech, devices)
- Collaborators
- Albany Medical College, The Cleveland Clinic, IGEA
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
The study consists of a screening period, surgical procedure, and 6 post-operative visits. At each indicated visit, quality of life scales and adverse events will be collected. In addition, at 4 weeks post-operatively, patients will undergo static lateral cervical plain x rays to assess implant positioning and integrity. At 3 months, 6 months, 12 months, 18 months, and 24 months, patients will undergo flexion/extension and neutral lateral plain radiographs to assess overall success and fusion.
The study has co-primary endpoints for efficacy (fusion) and overall success where overall success is defined as fusion, device implanted as intended, no serious adverse events related to the surgical procedure, no device-related serious adverse events, no subsequent surgical interventions at the index levels, and absence of clinically significant device malfunctions. Fusion data will be compared to benchmark data (Davis et al, 2013, control arm of the 2-level Mobi-C IDE study).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, first-in-human, multi-center, non-randomized, single arm study.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody SystemTwo-Level ACDF with CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System. |
Who may qualify
- Ages
- 22 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody SystemTwo-Level ACDF with CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System | Device | Treatment |
Primary outcome
Fusion
Time frame: 24 months.
Flexion-extension plain radiographs and CT scans will be used to assess bony fusion at both surgical levels.
1 secondary outcome
Device-Related Adverse Events
Time frame: 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John German, MD principal investigator
Albany Medical College
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System in people with Neck Pain and Spondylosis, run by ReVivo Medical, Corp. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric H Ledet, Ph.D. (5182270743, eledet@revivomedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion (time frame: 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.