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BAGUERA®C vs. Mobi-C® Implants for Cervical Disc Disease
N/A
Waitlist Available
Research Sponsored by Spineart USA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale.
Medically cleared for surgery.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 month follow-up visit
Awards & highlights
Study Summary
This trial is comparing two different types of implants for people with neck pain caused by damaged discs. One group will get the BAGUERA®C implant and the other will get the Mobi-C® implant. The trial will follow patients for 7 years to see how well the implants work.
Who is the study for?
This trial is for adults aged 22-69 with cervical disc disease causing neck/arm pain, weakness, or abnormal sensations. Participants must have tried non-surgical treatments without success and be fit for surgery. Exclusions include prior surgeries at the affected level, infections, severe diabetes, obesity (BMI > 40), osteoporosis/osteopenia, autoimmune diseases affecting muscles/bones, and allergies to certain metals.Check my eligibility
What is being tested?
The study compares two types of cervical disc prostheses: BAGUERA®C and Mobi-C®, in patients with symptomatic cervical disc disease. It's a randomized controlled trial where subjects are assigned to either device in a 2:1 ratio and followed up from surgery through seven years post-operation.See study design
What are the potential side effects?
Potential side effects may include discomfort at the implant site, infection risks associated with surgery, allergic reactions to materials in the devices (like Titanium or polyethylene), nerve damage leading to persistent pain or weakness, and possible need for additional surgeries.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My muscle strength has decreased by at least one level.
Select...
My doctor has approved me for surgery.
Select...
I am a candidate for surgery from the front of my neck and have not had previous neck surgeries.
Select...
I have neck pain due to a problem with a disc in my neck.
Select...
I have neck or arm pain rated at least 40 out of 100.
Select...
My neck or arm pain score is 40 or more out of 100.
Select...
I have neck or arm pain, weakness, numbness, or unusual reflexes due to a nerve issue in my neck.
Select...
I have neck or arm pain rated at least 4 out of 10.
Select...
I have nerve pain or weakness in my neck or arms from a spinal condition.
Select...
My muscle strength has decreased by at least one level.
Select...
My symptoms from nerve or spinal cord compression are getting worse despite treatment.
Select...
My neck or arm pain score is 40 or more.
Select...
I am between 22 and 69 years old and fully grown.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 month follow-up visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 month follow-up visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maintenance or improvement in neurological status
Neck Disability Index
No secondary surgical intervention per protocol definition
+1 moreSide effects data
From 2014 Phase 3 trial • 600 Patients • NCT018017356%
Urinary tract infection
6%
Arthralgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Meloxicam 10 mg
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BAGUERA®CExperimental Treatment1 Intervention
surgical placement of the BAGUERA®C Cervical Disc Prosthesis
Group II: Mobi-C®Active Control1 Intervention
surgical placement of the Mobi-C® Cervical Disc
Find a Location
Who is running the clinical trial?
Spineart USALead Sponsor
1 Previous Clinical Trials
300 Total Patients Enrolled
1 Trials studying Cervical Disc Disease
300 Patients Enrolled for Cervical Disc Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My muscle strength has decreased by at least one level.I take 5 mg or more of oral steroids every day.A decrease in height on a radiograph, CT scan, or MRI scan compared to a normal adjacent disc.My doctor has approved me for surgery.You have allergies to certain metals like titanium, vanadium, aluminum, cobalt, chromium, molybdenum, or polyethylene.I have a bone condition that is not osteoporosis.I have more than one fused spine bone in my neck from any cause.You have a problem with alcohol or drugs and need help to overcome it.I am a candidate for surgery from the front of my neck and have not had previous neck surgeries.I manage my severe diabetes with daily insulin.I had a cervical spine steroid injection within the last 14 days.I have neck pain due to a problem with a disc in my neck.I have neck pain due to cervical spine issues at multiple levels.I only have neck pain without any other nerve-related symptoms.I do not have conditions like neuromuscular disorders that would make it hard to assess my disease accurately.I have or might need treatment for an active infection like HIV or Hepatitis C.I have had spine surgery at the same spot before.My condition did not improve with standard non-surgical treatments.I have seizures that are not controlled by medication.I take high doses of steroids daily.I experience unusual sensations or changes in my reflexes.I have neck or arm pain rated at least 40 out of 100.Your NDI score is 30% or higher, which means you have significant disability in your neck and arm movements.I use inhaled corticosteroids twice a day every day.Your spine has a bend or curve greater than 11 degrees at the area being treated or the nearby areas.I have low bone density or osteoporosis as confirmed by a recent test.I am able and willing to follow the study's requirements and attend all scheduled visits.My symptoms started about six weeks ago.I have been cancer-free for 5 years, except for non-melanoma skin cancer.My neck or arm pain score is 40 or more out of 100.The text states that if a person has a disc herniation on a CT or MRI scan, then they likely have a disc herniation.I am currently experiencing a confirmed episode of a specific mental illness or have physical symptoms without a medical diagnosis.I haven't used any experimental drugs or devices in the last 30 days.I am not on high-dose steroids or drugs that affect healing.I have an autoimmune disease like rheumatoid arthritis or lupus.My severe back pain is due to facet joint degeneration, confirmed by tests.I have neck or arm pain, weakness, numbness, or unusual reflexes due to a nerve issue in my neck.I have birth defects in my bones or spinal cord that affect my spine's stability.I have neck or arm pain rated at least 4 out of 10.My back or neck condition hasn't improved with treatments like rest or physical therapy.I have had a serious neck injury between the C3 and C7 vertebrae.I have a crack or stress fracture in one of my vertebrae.I have had spine surgery in my neck before.I have nerve pain or weakness in my neck or arms from a spinal condition.I do not have any ongoing infections.I haven't taken high-dose steroids for short periods recently.My muscle strength has decreased by at least one level.The text is discussing a degenerative spine condition that can be seen on a CT scan or MRI.I experience unusual sensations, like feeling too much or too little.Your reflexes are not normal.My symptoms from nerve or spinal cord compression are getting worse despite treatment.My neck or arm pain score is 40 or more.There is a significant difference in the angle of your spine compared to the adjacent levels.You smoke more than a pack of cigarettes each day.I am between 22 and 69 years old and fully grown.
Research Study Groups:
This trial has the following groups:- Group 1: Mobi-C®
- Group 2: BAGUERA®C
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.
Cervical Disc Disease Patient Testimony for trial: Trial Name: NCT04520776 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the number of venues where this research experiment is being conducted?
"This study is now enrolling patients at The Huffman Clinic at Napa Valley Orthopaedic Group in Napa, Carolina Neurosurgery and Spine Associates in Charlotte, HOAG Orthopedicsin Orange, as well as 20 other medical centres."
Answered by AI
Is admission to this experiment currently available?
"According to records on clinicaltrials.gov, enrollment is currently open for this experiment which was first posted in March 2021 and last updated 3/21/2022."
Answered by AI
Does this research include elderly individuals aged 85 and above?
"Qualified individuals hoping to participate in this trial must be between 22 and 69 years old. There are 4 studies for minors and 117 trials targeting those over the age of 65."
Answered by AI
May I be a part of this clinical research?
"Candidates between the ages of 22 and 69 with spinal diseases are eligible to join this clinical trial. In total, 270 participants will be allowed to enter."
Answered by AI
How many individuals are engaging in the research at its current capacity?
"Affirmative. Based on the information presented by clinicaltrials.gov, this trial is actively looking for participants and has been since March 2nd 2021 when it was first posted. Currently there are 270 individuals enrolled across 23 sites."
Answered by AI
Who else is applying?
What state do they live in?
Oklahoma
Utah
How old are they?
18 - 65
What site did they apply to?
The Ohio Sate University - Dept of Orthopedics
Texas Back Institute
The Disc Replacement Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have had problems with my spine for several decades and my pain & discomfort is getting worse as time goes by. Mostly I get migraines from my cervical spine. I am curretny using Ejovy injections once a month which helps but I contiue to have issues.
PatientReceived no prior treatments
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