BAGUERA®C Cervical Disc Prosthesis for Cervical Disc Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
MORE Foundation, Phoenix, AZCervical Disc DiseaseBAGUERA®C Cervical Disc Prosthesis - Device
Eligibility
22 - 69
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Cervical Disc Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: 24 month follow-up visit

24 month follow-up visit
Maintenance or improvement in neurological status
Neck Disability Index
No secondary surgical intervention per protocol definition
Procedure or device related serious adverse events

Trial Safety

Safety Progress

1 of 3

Side Effects for

Meloxicam 10 mg
6%Urinary tract infection
6%Arthralgia
This histogram enumerates side effects from a completed 2014 Phase 3 trial (NCT01801735) in the Meloxicam 10 mg ARM group. Side effects include: Urinary tract infection with 6%, Arthralgia with 6%.

Trial Design

2 Treatment Groups

Mobi-C®
1 of 2
BAGUERA®C
1 of 2

Active Control

Experimental Treatment

270 Total Participants · 2 Treatment Groups

Primary Treatment: BAGUERA®C Cervical Disc Prosthesis · No Placebo Group · N/A

BAGUERA®C
Device
Experimental Group · 1 Intervention: BAGUERA®C Cervical Disc Prosthesis · Intervention Types: Device
Mobi-C®
Device
ActiveComparator Group · 1 Intervention: Mobi-C® Cervical Disc · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 month follow-up visit

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

Eligibility Criteria

Age 22 - 69 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have neck and/or arm pain, decreased muscle strength, abnormal sensation or reflexes, and symptomatic cervical disc disease (SCDD) at one level from C3 to C7.
You have been experiencing pain, numbness, or weakness in your back or neck for about six weeks and have tried non-surgical treatments like rest, physical therapy, or painkillers, but they have not helped. Alternatively, your symptoms have been getting worse despite these treatments.

Who else is applying?

What state do they live in?
Utah50.0%
Oklahoma50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Texas Back Institute50.0%
The Disc Replacement Center50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.