2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and prodisc C Vivo to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease (SCDD).
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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|Eligible Ages||18 Years - 69 Years|
Inclusion Criteria:1. Age ≥18 and ≤69 years. 2. Diagnosis of radiculopathy or myelopathy with radiculopathy of the cervical spine, with pain, paresthesias 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 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 ≥ 15/50 (or >30%). 6. Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for: 1. Approximately six weeks from radiculopathy or myelopathy with radiculopathy symptom onset; or 2. Have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative, conservative treatment; or 3. Sooner than 6 weeks for worsening symptoms of neurologic compromise.
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. Have 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. Have previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury. 5. Have had any prior spine surgery at the operative level(s). 6. Have had a prior cervical TDR or fusion procedure at any level. 7. Have axial neck pain in the absence of other symptoms of radiculopathy or myelopathy with radiculopathy justifying the need for surgical intervention. 8. Have disc height less than 3 mm as measured from the center of the disc in a neutral position and disc height less than 20% of the anterior-posterior width of the inferior vertebral body. 9. Have radiographic confirmation of severe facet joint disease or degeneration at any level. 10. Have an increased risk of osteoporosis per the Simple Calculated Osteoporosis Risk Estimation (SCORE) screening questionnaire (value ≥6) and confirmed by DEXA, if applicable. a. DEXA exclusion is defined as a DEXA bone density measured T-score of ≤ -1.5 or below (worse) (World Health Organization [WHO]). 11. Have Symptomatic Cervical Disc Disease or significant cervical spondylosis at more than two levels. 12. Have spondylolysis at any level. 13. Have marked cervical instability on resting (neutral) 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. 14. Have segmental angulation of greater than 11° at treatment or adjacent levels. 15. Have congenital bony and/or spinal cord abnormalities that affect spinal stability. 16. Have concomitant conditions requiring daily, high-dose oral and/or inhaled steroids. 17. Have a Body Mass Index (BMI) > 40 kg/m2. 18. Have had an epidural steroid injection within 14 days prior to surgery.
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||Centinel Spine|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Symptomatic Cervical Disc Disease|
The clinical trial is to demonstrate that prodisc C SK and prodisc C Vivo are at least as safe and effective as a similar, currently marketed cervical disc prosthesis to treat symptomatic cervical disc disease (SCDD) in subjects at two contiguous levels from C3 to C7 who are unresponsive to conservative management. Subjects will be randomized in a 2:1 ratio to either the two-level prodisc C SK or prodisc C Vivo device (investigational group) or to the two-level Mobi-C device (control group). Subjects will be followed for at least 2 years and up to 5 years. Subjects will be required to complete subject questionnaires, have X-rays and undergo neurological assessments during the follow up visits as specified in the protocol.
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