AzTrials
AzTrials

Cervical Disc DiseaseNCT04564885

A Clinical Trial Comparing the BAGUERA C to the Marketed Mobi-C® for the Treatment of Cervical Disc Disease at 2 Contiguous Levels

A study testing BAGUERA®C Cervical Disc Prosthesis and Mobi-C Cervical Disc in people with Cervical Disc Disease, run by Spineart USA at 26 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The proposed investigation is a multi-center, prospective, randomized, controlled comparison of the BAGUERA®C to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD) at two contiguous levels. Read more about this study

Who is it for?
Ages 22 to 69 years
Conditions the study is for
Cervical Disc Disease
What is being tested?
BAGUERA®C Cervical Disc Prosthesis and Mobi-C Cervical Disc
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
26 sitesUnited States
Study dates
2 Mar 2021to Apr 2030
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 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In order to be eligible to participate in this study, subjects must meet all of the following criteria:
  • Male or female; skeletally mature; age 22-69 years, inclusive.
  • 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
Show all 21Show fewer
  • Abnormal reflexes.
  • Symptomatic cervical disc disease (SCDD) at two contiguous levels from C3 to C7.
  • Radiographically determined pathology at the level to be treated correlating to primary symptoms including at least one of the following:
  • Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc.
  • Degenerative spondylosis on CT or MRI.
  • Disc herniation on CT or MRI.
  • NDI Score of ≥ 30% (raw score of ≥15/50).
  • Preoperative neck or arm pain ≥ 40 (out of 100) on Preoperative Neck and Arm Pain Questionnaire.
  • Unresponsive to non-operative, conservative treatment (including but not necessarily limited to: rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:
  • Approximately six weeks from radiculopathy or myeloradiculopathy symptom onset; or
  • Have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative conservative treatment.
  • Appropriate for treatment using an anterior surgical approach, including having no prior surgery at the operative level and no prior cervical fusion or cervical artificial disc procedure at any level.
  • Medically cleared for surgery.
  • Physically and mentally able and willing to comply with the Protocol, including the ability to read and complete required forms and willing and able to adhere to the scheduled follow-up visits and requirements of the Protocol.
  • Written informed consent provided by Subject

Who cannot join

  • Patients are not permitted to enroll in the two-level BAGUERA®C study if they meet any of the following exclusion criteria:
  • Have an active systemic infection or infection at the operative site.
  • Have a history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C.
  • More than one immobile vertebral level between C1 to C7 from any cause including but not limited to congenital abnormalities and osteoarthritic "spontaneous" fusions.
  • Previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury.
  • Had any prior spine surgery at the operative level(s).
Show all 40Show fewer
  • Had a prior fusion or artificial disc procedure at any cervical level.
  • Axial neck pain alone in the absence of other symptoms of radiculopathy or myeloradiculopathy.
  • Disc height less than 3 mm as measured from the center of the disc in a neutral lateral position.
  • Radiographic confirmation of severe facet joint degeneration or confirmed clinical evidence that facet joint degeneration is a major contributor to the subject's pain.
  • Have osteoporosis or osteopenia, defined as a DEXA bone density measured T-score of ≤ -1.5 (i.e. -1.6, -1.7, etc.). A DEXA performed within 24 months of the surgery date may be used to determine eligibility. For subjects without a DEXA within 24 months of the surgery date a score of ≥ 6 on either the SCORE or MORES requires a DEXA to determine eligibility. Note: The SCORE (Simple Calculated Osteoporosis Risk Estimation) form should be administered if the subject is female. The MORES (Male Osteoporosis Risk Estimation Score) form should be administered if the subject is male.
  • Have Paget's disease, osteomalacia or any other metabolic bone disease other than osteoporosis, which is addressed above.
  • Severe diabetes mellitus requiring daily insulin management.
  • Have an active malignancy that includes a history of any invasive malignancy (except non-melanoma skin cancer), unless the subject was treated with curative intent and there had been no clinical signs or symptoms of the malignancy for at least five years.
  • Symptomatic SCDD or significant cervical spondylosis at more than two levels.
  • Spondylolysis.
  • Marked cervical instability on resting lateral or flexion-extension radiographs demonstrated by:
  • Translation ≥ 3.5 mm, and/or
  • Greater than 11° angular difference to that of either adjacent level.
  • Known allergy to Titanium, Vanadium, Aluminum, Cobalt, Chromium, Molybdenum or Polyethylene.
  • Segmental angulation of greater than 11° at treatment or adjacent levels.
  • Pregnant at time of enrollment, or with plans to become pregnant within the next three years.
  • Have rheumatoid arthritis, lupus, or other autoimmune disease that affect the musculoskeletal system.
  • Congenital bony and/or spinal cord abnormalities that affect spinal stability.
  • Have diseases or conditions that would preclude accurate clinical evaluation (e.g. neuromuscular disorders, confirmed fibromyalgia, etc.).
  • Concomitant conditions requiring daily, high-dose oral and/or inhaled steroids. High dose steroid use is defined as:
  • Daily, chronic use of oral steroids of 5 mg/day or greater.
  • Daily, chronic use of inhaled corticosteroids (at least twice per day).
  • Use of short-term (less than 10 days) oral steroids at a daily dose greater than 40mg within one month of the study procedure.
  • Have current or recent history of substance abuse (alcoholism and/or narcotic addiction) requiring intervention.
  • Severe Obesity, as defined by National Institutes of Health (NIH) Clinical Guidelines Body Mass Index (BMI) > 40).
  • Use of any investigational drug or other investigational medical device within the last 30 days prior to surgery.
  • Taking medications known to interfere with bone/soft tissue healing (e.g., high-dose oral and/or inhaled steroids, immunosuppressant medication, chemotherapeutic agents). High dose steroid use is defined as part of Exclusion Criterion #23.
  • Currently pursuing litigation (defined as litigation that will likely influence the patient's ability or willingness to accurately report their treatment outcomes) related to the neck or cervical spine injury.
  • Current history of heavy nicotine use (e.g. more than one pack of cigarettes per day).
  • Circumstances that may interfere with completion of follow-up examinations, including location of residence.
  • Belong to a vulnerable population (e.g., prisoner, wards of the court or developmentally disabled).
  • Currently experiencing an acute or chronic episode of confirmed specific mental illness (psychosis, major affective disorder, or schizophrenia), or manifesting physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin.
  • Have an uncontrolled seizure disorder.
  • Received cervical spine epidural steroids within 14 days prior to surgery.

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

United States26 sites

  • Legacy Brain & Spine

    Atlanta, Georgia, 30339

  • St. David's Healthcare

    Austin, Texas, 78705

  • Indiana Spine Group

    Carmel, Indiana, 46032

  • Carolina Neurosurgery and Spine Associates

    Charlotte, North Carolina, 28204

  • Center for Sports Medicine & Orthopedics

    Chattanooga, Tennessee, 37404

  • Midwest Orthopedics at Rush

    Chicago, Illinois, 60612

  • The Ohio State University - Dept of Orthadedics

    Columbus, Ohio, 43210

  • NorthShore

    Evanston, Illinois, 60201

  • Ortho NorthEast

    Fort Wayne, Indiana, 46825

  • Hartford Health CT Orthopaedics

    Hamden, Connecticut, 06518

  • BEEL Medical

    Laguna Hills, California, 92653

  • Neurosurgical Associates of Lancaster

    Lancaster, Pennsylvania, 17601

  • Orange County Neurosurgical Associates

    Mission Viejo, California, 92691

  • UCI Health

    Orange, California, 92868

  • Orthopaedic Institute of Western Kentucky

    Paducah, Kentucky, 42001

  • MORE Foundation

    Phoenix, Arizona, 85023

  • Eisenhower Medical Center

    Rancho Mirage, California, 92270

  • The Disc Replacement Center

    Salt Lake City, Utah, 84088

  • The Spine Institute, Center for Spine Restoration

    Santa Monica, California, 90403

  • Desert Institute for Spine Care

    Scottsdale, Arizona, 85258

  • Swedish Neuroscience, Swedish Spine Institute

    Seattle, Washington, 98122

  • Spine Institute of Louisiana Foundation

    Shreveport, Louisiana, 71101

  • Oregon Spine Care

    Tualatin, Oregon, 97062

  • Vail-Summit Orthopaedics and Neurosurgery

    Vail, Colorado, 81657

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20057

  • Institute for Neuro Innovation

    West Hills, California, 91307

Other trials in United States

About this study

Official title: A Multicenter, Prospective, Randomized, Clinical Trial Comparing the Safety and Effectiveness of the BAGUERA C Cervical Disc Prosthesis to the Mobi-C® Cervical Disc for the Treatment of Patients With Symptomatic Cervical Disc Disease at Two Contiguous Levels

The proposed investigation is a multi-center, prospective, randomized, controlled comparison of the BAGUERA®C to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD) at two contiguous levels. Subjects will be randomized in a 2:1 ratio to the two-level BAGUERA®C Cervical Disc Prosthesis (investigational group) or to the two-level Mobi-C® Cervical Disc (control group). Subjects enrolled in the study will be evaluated pre-operatively, at the time of surgery, discharge, and at 6 weeks, 3, 6, 12, and 24 months and then annually until 7 years post-surgery.

Being tested
BAGUERA®C Cervical Disc Prosthesis, Mobi-C Cervical Disc
Keywords
radiculopathy, myeloradiculopathy
Medical subject headings
Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAGUERA®C Cervical Disc ProsthesisDevice

    surgery

  • Mobi-C Cervical DiscDevice

    surgery

Study groups in NCT04564885
Study groupRoleWhat they receive
BAGUERA®CExperimentalsurgical placement of the BAGUERA®C Cervical Disc Prosthesis at 2 contiguous levels
Receives: Device: BAGUERA®C Cervical Disc Prosthesis
Mobi-C®Active comparatorsurgical placement of the Mobi-C® Cervical Disc at 2 contiguous levels
Receives: Device: Mobi-C Cervical Disc

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neck Disability Index

    at least a 15 percentage point improvement (decrease) from baseline on a 0 - 100% scale

    Measured: 24 month follow-up visit

  2. Maintenance or improvement in neurological status

    pre and post-op neurological examination to determine maintenance or improvement

    Measured: 24 month follow-up visit

  3. No secondary surgical intervention per protocol definition

    any revision, removal, re-operation, or supplemental fixation at the index level

    Measured: 24 month follow-up visit

  4. Procedure or device related serious adverse events

    No serious adverse event(s) confirmed as device or procedure related as adjudicated by the Clinical Events Committee

    Measured: 24 month follow-up visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2020
  2. Study start2 Mar 2021
  3. Primary completionApr 2025 (estimated)
  4. Study completionApr 2030 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04564885
Sponsor's protocol ID
CT-20-002-001
Status last verified
Mar 2024
First submitted
21 Sep 2020
Last updated
8 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing BAGUERA®C Cervical Disc Prosthesis and Mobi-C Cervical Disc in people with Cervical Disc Disease, run by Spineart USA at 26 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 21 inclusion and 40 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: under way, not looking for participants, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neck Disability Index (time frame: 24 month follow-up visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04564885.

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 8 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in