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Orthopedic Device
CEM-Plate and CEM-Cage Devices for Cervical Disc Disorder
N/A
Recruiting
Led By James Lawrence, MD
Research Sponsored by ReVivo Medical, Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented diagnosis of cervical spine radiculopathy or myelopathy.
Baseline NDI score ≥30 and/or baseline mJOA score ≤16.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months.
Awards & highlights
Study Summary
This trial is testing a new device for a 2-level ACDF. The device will be evaluated for safety and efficacy in 50 patients.
Who is the study for?
This trial is for adults aged 22-79 with neck pain and spinal issues due to cervical disc disorder, who haven't improved after 6 weeks of non-surgical treatment. Candidates must have specific scores on NDI or mJOA scales, confirmed symptoms by imaging, and be able to consent. Exclusions include prior cervical surgeries at the affected levels, certain bone diseases, severe instability or infection in the spine area, high-dose steroid use, substance abuse history, pregnancy, metal allergies and a BMI over 40.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of CEM-Cage with CEM-Plate in patients needing a two-level anterior cervical discectomy and fusion (ACDF). Fifty participants will undergo ACDF using these devices and will be monitored regularly up to two years post-operation.See study design
What are the potential side effects?
Potential side effects may include typical surgical risks such as infection at the site of implantation, inflammation around the area where devices are placed; allergic reactions if there's an undiagnosed metal allergy; complications from anesthesia; nerve damage that could lead to pain or numbness; difficulty swallowing; bleeding or blood clots.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with nerve or spinal cord issues in my neck.
Select...
My neck disability or arm function scores indicate significant impairment.
Select...
I have neck pain due to disc problems in my spine from C2 to T1.
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My symptoms match the imaging results of my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fusion
Secondary outcome measures
Device-Related Adverse Events
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Two-Level ACDF with CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System.
Find a Location
Who is running the clinical trial?
ReVivo Medical, Corp.Lead Sponsor
Albany Medical CollegeOTHER
91 Previous Clinical Trials
11,447 Total Patients Enrolled
The Cleveland ClinicOTHER
1,027 Previous Clinical Trials
1,364,228 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a fever.I have neck pain without any nerve or spinal cord issues needing surgery.I have been diagnosed with nerve or spinal cord issues in my neck.I have more than one fused spine bone in my neck from any cause.My neck is very unstable and needs surgery based on X-ray results.I have signs of swelling or redness.You can't have an implant that would get in the way of your body's normal function.I have had a serious neck injury affecting my spine.I have poor tissue or bone quality at the surgery site.I have open wounds.You have an allergy or intolerance to metal.You have a history of alcohol or drug addiction that required treatment.I have had cancer before, but it was not skin cancer and I've been symptom-free for over 5 years.I do not have any health issues that would interfere with this study's evaluations.You have a body mass index (BMI) higher than 40.I haven't used any experimental drugs or devices in the last 30 days.I have or expect to be treated for an active infection like HIV or Hepatitis C.I am willing to follow all post-operative instructions.My neck disability or arm function scores indicate significant impairment.I do not have conditions that would make spinal implant surgery risky for me.I have neck pain due to disc problems in my spine from C2 to T1.I use high-dose steroids daily or have a history of doing so.I have had surgery to remove part of my spine.My symptoms match the imaging results of my condition.My spine condition hasn't improved after 6 weeks of non-surgical treatment.I have a bone condition that is not osteoporosis.I have osteoporosis and am either on medication for it or have been advised against surgery due to bone density issues.I have had surgery on my neck at the level causing symptoms or any cervical fusion.I need treatment for either less than 2 or more than 2 of my spine levels.My body is not suitable for the trial device.I do not have any ongoing infections.You smoke more than 20 cigarettes a day.I am between 22 and 79 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the research encompass individuals below the age of twenty?
"As specified in the study's inclusion criteria, individuals aged 22 to 79 are eligible to apply. Additionally, there are 7 studies targeting those under 18 and 154 for people over 65 years old."
Answered by AI
How can I participate in this research?
"This medical study is aiming to enroll 50 participants aged 22-79 who are suffering from neck pain. Additional criteria for inclusion include: symptomatic cervical degenerative disc disease at two consecutive levels between C2 and T1, a baseline Neck Disability Index (NDI) score of 30 or higher, and/or a modified Japanese Orthopaedic Association (mJOA) score of 16 or lower; as well as an inability to respond positively to conservative treatments over the course of 6 weeks since symptom onset or clear signs of nerve root compression or spinal cord damage in spite of continued non-operative care."
Answered by AI
How many participants are currently receiving treatment in this experiment?
"Affirmative. Clinicaltrials.gov confirms that as of April 25th, this medical trial is actively seeking volunteers for participation. Since it's posting on March 7th 2022, the study has been looking to enroll 50 people from two distinct locations."
Answered by AI
Are there currently openings for people to join this experiment?
"The latest information available on clinicaltrials.gov affirms that this trial is actively recruiting patients, with the initial posting occurring March 7th 2022 and a subsequent update on April 25th of the same year."
Answered by AI
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