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

Running, not enrolling · Not applicable

Conditions studied: Cervical Disc Disease

In brief

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.

Key facts

Study ID: NCT04564885
Run by: Spineart USA
People needed: 300
Starts: 2021-03-02
Expected to finish: 2030-04-01
Last updated by the study team: 2024-03-08

Who can join

Age: 22 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
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

You may not qualify if…

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).
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.).

Where it is running

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

Full record on ClinicalTrials.gov

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