A Clinical Trial Comparing the BAGUERA®C to the Marketed Mobi-C® for the Treatment of Single Level Cervical Disc Disease

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). Subjects will be randomized in a 2:1 ratio to the one-level BAGUERA®C Cervical Disc Prosthesis (investigational group) or to the one-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

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 30 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 one level 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 pain ≥ 30 (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. Patients are not permitted to enroll in the one-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. 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. 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. 13. Symptomatic SCDD or significant cervical spondylosis at more than one level. 14. Spondylolysis. 15. 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. 16. Known allergy to Titanium, Vanadium, Aluminum, cobalt, chromium, molybdenum or polyethylene. 17. Segmental angulation of greater than 11° at treatment or adjacent levels. 18. Pregnant at time of enrollment, or with plans to become pregnant within the next three years. 19. Have rheumatoid arthritis, lupus, or other autoimmune disease that affect the musculoskeletal system. 20. Congenital bony and/or spinal cord abnormalities that affect spinal stability. 21. Have diseases or conditions that would preclude accurate clinical evaluation (e.g. neuromuscular disorders, confirmed fibromyalgia, etc.). 22. 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. 23. Have current or recent history of substance abuse (alcoholism and/or narcotic addiction) requiring intervention. 24. Severe Obesity, as defined by National Institutes of Health (NIH) Clinical Guidelines Body Mass Index (BMI) > 40). 25. Use of any investigational drug or other investigational medical device within the last 30 days prior to surgery. 26. 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 #22. 27. Have pending personal litigation relating to a spinal injury (does not include worker's compensation). 28. Current history of heavy nicotine use (e.g. more than one pack of cigarettes per day). 29. Circumstances that may interfere with completion of follow-up examinations, including location of residence. 30. Have mental illness or belong to a vulnerable population (e.g., prisoner or developmentally disabled), that in the belief of the Investigator would compromise ability to provide informed consent or compliance with other study requirements. 31. Have an uncontrolled seizure disorder. 32. 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.

NCT04520776
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

Active Comparator: Mobi-C®

surgical placement of the Mobi-C® Cervical Disc

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.

Desert Institute for Spine Care, Scottsdale, Arizona

Status

Recruiting

Address

Desert Institute for Spine Care

Scottsdale, Arizona, 85258

Site Contact

Jennifer Camoriano

[email protected]

949-313-6400

Santa Monica, California

Status

Recruiting

Address

The Spine Institute, Center for Spine Restoration

Santa Monica, California, 90403

Site Contact

Federico Girardi

[email protected]

949-313-6400

NorthShore University, Evanston, Illinois

Status

Recruiting

Address

NorthShore University

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

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, Shreveport, Louisiana

Status

Recruiting

Address

Spine Institute of Louisiana

Shreveport, Louisiana, 71101

Site Contact

Heather Bowman, RN

[email protected]

949-313-6400

Charlotte, North Carolina

Status

Recruiting

Address

Carolina Neurosurgery and Spine Associates

Charlotte, North Carolina, 28204

Site Contact

Peggy Boltes, RN

[email protected]

949-313-6400

Columbus, Ohio

Status

Recruiting

Address

The Ohio Sate University - Dept of Orthopedics

Columbus, Ohio, 43210

Site Contact

Beth Sheriden Wagg

[email protected]

949-313-6400

Oregon Spine Care, Tualatin, Oregon

Status

Recruiting

Address

Oregon Spine Care

Tualatin, Oregon, 97062

Site Contact

Kelsey Gretzinger, PA-C

[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

Matt Allred

[email protected]

949-313-6400