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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04520776
Other study ID # CT-20-001-001
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 2, 2021
Est. completion date February 2026

Study information

Verified date February 2024
Source Spineart USA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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 information / eligibility

Status Active, not recruiting
Enrollment 284
Est. completion date February 2026
Est. primary completion date February 2026
Accepts healthy volunteers No
Gender All
Age group 22 Years to 69 Years
Eligibility 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 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 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 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. 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 one level. 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. Have pending personal litigation relating to a spinal injury (does not include worker's compensation). 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.

Study Design


Intervention

Device:
BAGUERA®C Cervical Disc Prosthesis
surgery
Mobi-C® Cervical Disc
surgery

Locations

Country Name City State
United States Legacy Brain & Spine Atlanta Georgia
United States St. David's Healthcare Austin Texas
United States Indiana Spine Group Carmel Indiana
United States Carolina Neurosurgery and Spine Associates Charlotte North Carolina
United States Center for Sports Medicine & Orthopedics Chattanooga Tennessee
United States Midwest Orthopedics at RUSH Chicago Illinois
United States The Ohio Sate University - Dept of Orthopedics Columbus Ohio
United States NorthShore University Evanston Illinois
United States Ortho NorthEast Fort Wayne Indiana
United States Hartford Healthcare CT Orthopaedics Hamden Connecticut
United States BEEL Medical Laguna Hills California
United States Neurosurgical Associates of Lancaster Lancaster Pennsylvania
United States Orange County Neurosurgical Associates Mission Viejo California
United States The Huffman Clinic at Napa Valley Orthopaedic Group Napa California
United States UCI Health Orange California
United States Orthopaedic Institute of Western Kentucky Paducah Kentucky
United States MORE Foundation Phoenix Arizona
United States Eisenhower Medical Center Rancho Mirage California
United States The Disc Replacement Center Salt Lake City Utah
United States The Spine Institute, Center for Spine Restoration Santa Monica California
United States Desert Institute for Spine Care Scottsdale Arizona
United States Swedish Neuroscience, Swedish Spine Institute Seattle Washington
United States Spine Institute of Louisiana Shreveport Louisiana
United States Oregon Spine Care Tualatin Oregon
United States Vail-Summit Orthopaedics and Neurosurgery Vail Colorado
United States Georgetown University Medical Center Washington District of Columbia
United States The Institute of Neuro Innovation West Hills California

Sponsors (1)

Lead Sponsor Collaborator
Spineart USA

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neck Disability Index at least a 15 percentage point improvement (decrease) from baseline 24 month follow-up visit
Primary Maintenance or improvement in neurological status pre and post-op neurological examination to determine maintenance or improvement 24 month follow-up visit
Primary No secondary surgical intervention per protocol definition any revision, removal, re-operation, or supplemental fixation at the index level 24 month follow-up visit
Primary 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 24 month follow-up visit
See also
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Not yet recruiting NCT03367052 - Clinical and Radiological Outcomes: Two-level Cervical ProDisc-C Vivo Versus Hybrid Construct. N/A