Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||22 Years - 69 Years|
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
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Cervical Disc Disease|
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
Device: - BAGUERA®C Cervical Disc Prosthesis
Device: - Mobi-C Cervical Disc
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.