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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 22 Years - 69 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria. In order to be eligible to participate in this study, subjects must meet all of the following criteria: 1. Male or female; skeletally mature; age 22-69 years, inclusive. 2. 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: 1. Neck and/or arm pain (at least 40 mm on the 100 mm visual analogue scale [VAS] scale). 2. Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale. 3. Abnormal sensation including hyperesthesia or hypoesthesia; and/or. 4. Abnormal reflexes. 3. Symptomatic cervical disc disease (SCDD) at two contiguous levels from C3 to C7. 4. Radiographically determined pathology at the level to be treated correlating to primary symptoms including at least one of the following: 1. Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc. 2. Degenerative spondylosis on CT or MRI. 3. Disc herniation on CT or MRI. 5. NDI Score of ≥ 30% (raw score of ≥15/50). 6. Preoperative neck or arm pain ≥ 40 (out of 100) on Preoperative Neck and Arm Pain Questionnaire. 7. Unresponsive to non-operative, conservative treatment (including but not necessarily limited to: rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for: 1. Approximately six weeks from radiculopathy or myeloradiculopathy symptom onset; or. 2. Have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative conservative treatment. 8. 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. 9. Medically cleared for surgery. 10. 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. 11. Written informed consent provided by Subject. Exclusion Criteria. Patients are not permitted to enroll in the two-level BAGUERA®C study if they meet any of the following

exclusion criteria:

1. Have an active systemic infection or infection at the operative site. 2. Have a history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C. 3. More than one immobile vertebral level between C1 to C7 from any cause including but not limited to congenital abnormalities and osteoarthritic "spontaneous" fusions. 4. Previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury. 5. Had any prior spine surgery at the operative level(s). 6. Had a prior fusion or artificial disc procedure at any cervical level. 7. Axial neck pain alone in the absence of other symptoms of radiculopathy or myeloradiculopathy. 8. Disc height less than 3 mm as measured from the center of the disc in a neutral lateral position. 9. Radiographic confirmation of severe facet joint degeneration or confirmed clinical evidence that facet joint degeneration is a major contributor to the subject's pain. 10. 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. 11. Have Paget's disease, osteomalacia or any other metabolic bone disease other than osteoporosis, which is addressed above. 12. Severe diabetes mellitus requiring daily insulin management. 13. 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. 14. Symptomatic SCDD or significant cervical spondylosis at more than two levels. 15. Spondylolysis. 16. Marked cervical instability on resting lateral or flexion-extension radiographs demonstrated by: 1. Translation ≥ 3.5 mm, and/or. 2. Greater than 11° angular difference to that of either adjacent level. 17. Known allergy to Titanium, Vanadium, Aluminum, Cobalt, Chromium, Molybdenum or Polyethylene. 18. Segmental angulation of greater than 11° at treatment or adjacent levels. 19. Pregnant at time of enrollment, or with plans to become pregnant within the next three years. 20. Have rheumatoid arthritis, lupus, or other autoimmune disease that affect the musculoskeletal system. 21. Congenital bony and/or spinal cord abnormalities that affect spinal stability. 22. Have diseases or conditions that would preclude accurate clinical evaluation (e.g. neuromuscular disorders, confirmed fibromyalgia, etc.). 23. Concomitant conditions requiring daily, high-dose oral and/or inhaled steroids. High dose steroid use is defined as: 1. Daily, chronic use of oral steroids of 5 mg/day or greater. 2. Daily, chronic use of inhaled corticosteroids (at least twice per day). 3. Use of short-term (less than 10 days) oral steroids at a daily dose greater than 40mg within one month of the study procedure. 24. Have current or recent history of substance abuse (alcoholism and/or narcotic addiction) requiring intervention. 25. Severe Obesity, as defined by National Institutes of Health (NIH) Clinical Guidelines Body Mass Index (BMI) > 40). 26. Use of any investigational drug or other investigational medical device within the last 30 days prior to surgery. 27. 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. 28. 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. 29. Current history of heavy nicotine use (e.g. more than one pack of cigarettes per day). 30. Circumstances that may interfere with completion of follow-up examinations, including location of residence. 31. Belong to a vulnerable population (e.g., prisoner, wards of the court or developmentally disabled). 32. 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. 33. Have an uncontrolled seizure disorder. 34. Received cervical spine epidural steroids within 14 days prior to surgery.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04564885
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Spineart USA
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cervical Disc Disease
Arms & Interventions

Arms

Experimental: BAGUERA®C

surgical placement of the BAGUERA®C Cervical Disc Prosthesis at 2 contiguous levels

Active Comparator: Mobi-C®

surgical placement of the Mobi-C® Cervical Disc at 2 contiguous levels

Interventions

Device: - BAGUERA®C Cervical Disc Prosthesis

surgery

Device: - Mobi-C Cervical Disc

surgery

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

MORE Foundation, Phoenix, Arizona

Status

Recruiting

Address

MORE Foundation

Phoenix, Arizona, 85023

Site Contact

Leesa Maczko

[email protected]

949-313-6400

Desert Institute for Spine Care, Scottsdale, Arizona

Status

Recruiting

Address

Desert Institute for Spine Care

Scottsdale, Arizona, 85258

Site Contact

Jennifer Camiorano

[email protected]

949-313-6400

BEEL Medical, Laguna Hills, California

Status

Recruiting

Address

BEEL Medical

Laguna Hills, California, 92653

Site Contact

Haley Stauber

[email protected]

949-313-6400

Orange County Neurosurgical Associates, Mission Viejo, California

Status

Recruiting

Address

Orange County Neurosurgical Associates

Mission Viejo, California, 92691

Site Contact

Darin Johnson, PA-C

[email protected]

949-313-6400

Napa, California

Status

Withdrawn

Address

The Huffman Clinic at Napa Valley Orthopaedic Group

Napa, California, 94558

HOAG Orthopedics, Orange, California

Status

Withdrawn

Address

HOAG Orthopedics

Orange, California, 92868

UCI Health, Orange, California

Status

Recruiting

Address

UCI Health

Orange, California, 92868

Site Contact

Brandon Lehman

[email protected]

949-313-6400

Eisenhower Medical Center, Rancho Mirage, California

Status

Recruiting

Address

Eisenhower Medical Center

Rancho Mirage, California, 92270

Site Contact

Kate Formaker, RN

[email protected]

760-766-2540

UCSF Dept of Neurosurgery, San Francisco, California

Status

Withdrawn

Address

UCSF Dept of Neurosurgery

San Francisco, California, 94143

Santa Monica, California

Status

Recruiting

Address

The Spine Institute, Center for Spine Restoration

Santa Monica, California, 90403

Site Contact

Nicholas Kull

[email protected]

949-313-6400

Institute for Neuro Innovation, West Hills, California

Status

Recruiting

Address

Institute for Neuro Innovation

West Hills, California, 91307

Site Contact

Jack Petros

[email protected]

949-313-6400

Mountain View Spine Center, Louisville, Colorado

Status

Withdrawn

Address

Mountain View Spine Center

Louisville, Colorado, 80027

Vail, Colorado

Status

Recruiting

Address

Vail-Summit Orthopaedics and Neurosurgery

Vail, Colorado, 81657

Site Contact

Kyle Brenna

[email protected]

949-313-6400

Hartford Health CT Orthopaedics, Hamden, Connecticut

Status

Recruiting

Address

Hartford Health CT Orthopaedics

Hamden, Connecticut, 06518

Site Contact

Jessica Stine

[email protected]

949-313-6400

Georgetown University Medical Center, Washington, District of Columbia

Status

Recruiting

Address

Georgetown University Medical Center

Washington, District of Columbia, 20057

Site Contact

Emily Jesko

[email protected]

949-313-6400

Legacy Brain & Spine, Atlanta, Georgia

Status

Recruiting

Address

Legacy Brain & Spine

Atlanta, Georgia, 30339

Site Contact

Wes Williams

[email protected]

949-313-6400

Midwest Orthopedics at Rush, Chicago, Illinois

Status

Recruiting

Address

Midwest Orthopedics at Rush

Chicago, Illinois, 60612

Site Contact

Kavita A Ahuja

[email protected]

949-313-6400

NorthShore, Evanston, Illinois

Status

Recruiting

Address

NorthShore

Evanston, Illinois, 60201

Site Contact

Boris Jancan

[email protected]

949-313-6400

Indiana Spine Group, Carmel, Indiana

Status

Recruiting

Address

Indiana Spine Group

Carmel, Indiana, 46032

Site Contact

Sheetal Vinayek

[email protected]

949-313-6400

Ortho NorthEast, Fort Wayne, Indiana

Status

Recruiting

Address

Ortho NorthEast

Fort Wayne, Indiana, 46825

Site Contact

Tom Pawlik

[email protected]

949-313-6400

Paducah, Kentucky

Status

Recruiting

Address

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42001

Site Contact

Rebekah Vinson

[email protected]

949-313-6400

Spine Institute of Louisiana Foundation, Shreveport, Louisiana

Status

Recruiting

Address

Spine Institute of Louisiana Foundation

Shreveport, Louisiana, 71101

Site Contact

Heather Bowman, RN, BSN

[email protected]

949-313-6400

Charlotte, North Carolina

Status

Recruiting

Address

Carolina Neurosurgery and Spine Associates

Charlotte, North Carolina, 28204

Site Contact

Ginger Barr, RN

[email protected]

949-313-6400

Columbus, Ohio

Status

Recruiting

Address

The Ohio State University - Dept of Orthadedics

Columbus, Ohio, 43210

Site Contact

Nazihah Bhatti

[email protected]

949-313-6400

Oregon Spine Care, Tualatin, Oregon

Status

Recruiting

Address

Oregon Spine Care

Tualatin, Oregon, 97062

Site Contact

Kelsey Gretzinger

[email protected]

949-313-6400

Neurosurgical Associates of Lancaster, Lancaster, Pennsylvania

Status

Recruiting

Address

Neurosurgical Associates of Lancaster

Lancaster, Pennsylvania, 17601

Site Contact

Nichole Beaty

[email protected]

949-313-6400

Center for Sports Medicine & Orthopedics, Chattanooga, Tennessee

Status

Active, not recruiting

Address

Center for Sports Medicine & Orthopedics

Chattanooga, Tennessee, 37404

St. David's Healthcare, Austin, Texas

Status

Recruiting

Address

St. David's Healthcare

Austin, Texas, 78705

Site Contact

Krishna Saini

[email protected]

949-313-6400

The Disc Replacement Center, Salt Lake City, Utah

Status

Recruiting

Address

The Disc Replacement Center

Salt Lake City, Utah, 84088

Site Contact

Matthew Allred

[email protected]

949-313-6400

Seattle, Washington

Status

Recruiting

Address

Swedish Neuroscience, Swedish Spine Institute

Seattle, Washington, 98122

Site Contact

Mark Loreen

[email protected]

206-320-7121