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Prosthesis
BAGUERA®C vs Mobi-C 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
Diagnosis of radiculopathy or myeloradiculopathy of the cervical spine, with pain, paresthesia or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following: Neck and/or arm pain (at least 40 mm on the 100 mm visual analogue scale [VAS] scale). Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale. Abnormal sensation including hyperesthesia or hypoesthesia; and/or Abnormal reflexes.
Male or female; skeletally mature; age 22-69 years, inclusive.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 month follow-up visit
Awards & highlights
Study Summary
This trial is testing a new disc replacement device called the BAGUERA®C to see if it is better than a similar, legally marketed device for people with SCDD. Subjects will be randomized to either the investigational group or the control group, and will be evaluated before and after surgery, and then annually for 7 years.
Who is the study for?
Adults aged 22-69 with cervical disc disease at two levels from C3 to C7, experiencing neck or arm pain and other symptoms despite non-operative treatment. Must have certain radiographic signs of degeneration or herniation, be medically cleared for surgery, and able to follow the study protocol. Excludes those with severe bone diseases, prior cervical surgeries, infections, certain allergies, autoimmune diseases affecting musculoskeletal system, obesity (BMI > 40), heavy nicotine use or substance abuse.Check my eligibility
What is being tested?
The trial is comparing BAGUERA®C Cervical Disc Prosthesis with Mobi-C® Cervical Disc in treating symptomatic cervical disc disease. Participants are randomly assigned in a 2:1 ratio to either the investigational device (BAGUERA®C) or control device (Mobi-C®). They will be monitored from pre-surgery up until seven years post-surgery.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 if sensitivity exists. Long-term effects could involve issues related to wear and tear of prosthetic components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have neck or arm pain, weakness, unusual sensations, or reflex problems due to a spine condition.
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I am between 22 and 69 years old and fully grown.
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I have neck pain due to issues in my cervical spine at two levels between C3 and C7.
Select...
I am approved by a doctor to have surgery.
Select...
My muscle strength has decreased by at least one level.
Select...
I have nerve pain or weakness in my neck or arms from a spine condition.
Select...
My symptoms from nerve or spinal cord compression are getting worse despite treatment.
Select...
I have neck or arm pain rated at least 40 out of 100.
Select...
I am a candidate for surgery from the front of my neck and have not had previous neck surgeries.
Select...
I have back or neck issues confirmed by scans and significant pain or disability.
Select...
My neck or arm pain score is 40 or more.
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 at 2 contiguous levels
Group II: Mobi-C®Active Control1 Intervention
surgical placement of the Mobi-C® Cervical Disc at 2 contiguous levels
Find a Location
Who is running the clinical trial?
Spineart USALead Sponsor
1 Previous Clinical Trials
284 Total Patients Enrolled
1 Trials studying Cervical Disc Disease
284 Patients Enrolled for Cervical Disc Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My severe back pain is due to facet joint problems confirmed by tests.I have had a serious neck injury between the C3 and C7 vertebrae.I have neck or arm pain, weakness, unusual sensations, or reflex problems due to a spine condition.I have an autoimmune disease like rheumatoid arthritis or lupus.I have a bone condition that is not osteoporosis.I am between 22 and 69 years old and fully grown.I had a cervical spine steroid injection within the last 14 days.I am not on high-dose steroids or medications that affect healing.I have neck pain due to issues in my cervical spine at two levels between C3 and C7.I have more than one fused spine bone in my neck from any cause.I am approved by a doctor to have surgery.I take high doses of steroids daily.I take 5 mg or more of oral steroids every day.I use inhaled corticosteroids twice a day every day.My muscle strength has decreased by at least one level.I have been cancer-free for 5 years, except for non-melanoma skin cancer.I have a birth defect in my bones or spinal cord that affects my spine's stability.I am involved in a lawsuit related to a neck or spine injury.I am currently experiencing a confirmed episode of a specific mental illness or have physical symptoms without a medical diagnosis.I haven't taken high doses of oral steroids for short periods recently.I have a crack or stress fracture in my spine.I experience unusual sensations or numbness.My symptoms match my scan results for the area being treated.I have nerve pain or weakness in my neck or arms from a spine condition.I have seizures that are not controlled by medication.I have had spine surgery at the same spot before.I only have neck pain without any other nerve-related symptoms.My back or neck condition hasn't improved with treatments like rest or physical therapy.I have had a spine surgery in my neck area before.My symptoms from nerve or spinal cord compression are getting worse despite treatment.I do not have conditions like neuromuscular disorders that would affect my clinical evaluation.I have neck or arm pain rated at least 40 out of 100.My neck X-rays show significant instability.I am a candidate for surgery from the front of my neck and have not had previous neck surgeries.I have severe neck pain or problems due to spine issues at more than two levels.I am able and willing to follow the study's requirements and attend all scheduled visits.I have back or neck issues confirmed by scans and significant pain or disability.My neck or arm pain score is 40 or more.My condition did not improve with standard non-surgical treatments.I have low bone density as confirmed by a recent test.I do not have any ongoing infections.I have or might need treatment for an active infection like HIV or Hepatitis C.My symptoms started about six weeks ago.I manage my severe diabetes with daily insulin.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for me to participate in this experiment?
"This medical study is enrolling 300 individuals aged between 22 and 69 who have been diagnosed with spinal conditions. In order to qualify, participants must be suffering from preoperative neck or arm pain at a severity of 40 out of 100 as determined by the Preoperative Neck and Arm Pain Questionnaire; symptomatic cervical disc disease in two consecutive levels ranging from C3 to C7, weakened muscles at one level on the clinical evaluation 0-5 scale; altered sensation including hyperesthesia or hypoesthesia, abnormal reflexes; and an NDI Score measuring 30% (raw score > 15/50)."
Answered by AI
Are there currently any vacancies for potential participants in this research experiment?
"The data posted on clinicaltrials.gov reveals that this medical trial is currently recruiting participants; it was first announced on March 2nd 2021 and revised as of March 21st 2022."
Answered by AI
Are there numerous health facilities conducting this experiment in the city?
"As of now, this clinical trial is recruiting patients from a total of 21 sites. Of these locations, there are clinics in Scottsdale, Fort Wayne and Santa Monica as well other ones dispersed across the country. To abate travel requirements for those enrolled, it is essential to select the closest site available."
Answered by AI
Is elderly participation acceptable in this experiment?
"The research parameters dictate that patients enrolling in this trial are between 22 and 69 years old. Furthermore, there are 4 studies specifically designed for younger individuals under 18 and 117 trials dedicated to those aged over 65."
Answered by AI
How many patients have signed on to participate in this experiment?
"Spineart USA, the entity sponsoring this project, needs to source 300 individuals who meet all eligibility requirements for participation. This trial will be conducted from Desert Institute for Spine Care in Scottsdale, Arizona and Ortho NorthEast in Fort Wayne, Indiana among other locations."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
The Ohio State University - Dept of Orthadedics
St. David's Healthcare
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
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