2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C (NCT04012996) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
United States390 participantsStarted 2019-08-05
Plain-language summary
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).
Who can participate
Age range18 Years – 69 Years
SexALL
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Inclusion criteria
✓. Age ≥18 and ≤69 years.
✓. 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:
✓. 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.
✓. Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics)
Exclusion criteria
✕. 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.
✕. Have previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury.
✕. Have had a prior cervical TDR or fusion procedure at any level.
✕. Have osteoporosis or is at increased risk of osteoporosis
✕. Have active malignancy that included a history of any invasive malignancy (except non-melanoma skin cancer), unless the subject had been treated with curative intent and there had been no clinical signs or symptoms of the malignancy for at least 5 years.
✕
What they're measuring
1
Composite clinical success rate of the two-level prodisc C SK and prodisc C Vivo will be no worse than marketed cervical disc prosthesis (Mobi-C)