Cervical Disc Disease
Conditions
Keywords
radiculopathy, myeloradiculopathy
Brief 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. 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.
Interventions
surgery
DEVICEMobi-C Cervical Disc
surgery
Sponsors
Spineart USA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
participants will not be told their treatment group prior to surgery
Eligibility
Sex/Gender
ALL
Age
22 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neck Disability Index | 24 month follow-up visit | at least a 15 percentage point improvement (decrease) from baseline on a 0 - 100% scale |
| Maintenance or improvement in neurological status | 24 month follow-up visit | pre and post-op neurological examination to determine maintenance or improvement |
| No secondary surgical intervention per protocol definition | 24 month follow-up visit | any revision, removal, re-operation, or supplemental fixation at the index level |
| Procedure or device related serious adverse events | 24 month follow-up visit | No serious adverse event(s) confirmed as device or procedure related as adjudicated by the Clinical Events Committee |
Countries
United States
Outcome results
None listed