CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study (NCT04883411) | Clinical Trial Compass
RecruitingNot Applicable
CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study
United States50 participantsStarted 2022-03-07
Plain-language summary
The study is a prospective, first-in-human, multi-center, non-randomized, single-arm study to assess the safety and efficacy of the CEM-Cage used with the CEM-Plate in patients who are appropriate candidates for a 2-level anterior cervical discectomy and fusion (ACDF). Fifty patients will be enrolled in the study and, after undergoing a 2-level ACDF, will be evaluated at 4 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.
Who can participate
Age range22 Years – 79 Years
SexALL
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Inclusion criteria
✓. Males and females aged 22-79 years.
✓. Documented diagnosis of cervical spine radiculopathy or myelopathy.
✓. Symptomatic cervical degenerative disc disease at 2 contiguous levels between C2 through T1.
✓. Baseline NDI score ≥30 and/or baseline mJOA score ≤16.
✓. Pathology at the level to be treated correlating to the primary symptoms confirmed by imaging (computed tomography (CT), CT myelography, magnetic resonance imaging (MRI), or plain radiography).
✓. Unresponsive to non-operative, conservative treatment for at least 6 weeks from symptom onset or presence of progressive cervical myelopathy or signs of nerve root/spinal cord compression despite continued non-operative treatment.
✓. Ability to speak, read, and understand the IRB approved Informed Consent document.
✓. Willingness to give informed consent for participation in the study.
Exclusion criteria
✕. Any prior cervical surgeries at the symptomatic levels; prior surgery or cervical fusion procedure at any level.
✕. Fewer than 2 or more than 2 vertebral levels requiring treatment.
✕. Anatomy that is non-conducive to receiving investigational device.
✕. More than one immobile vertebral level between C-1 to C-7 from any cause, including but not limited to congenital abnormalities and osteoarthritic "spontaneous" fusions.
✕. Known diagnosis of osteoporosis, current pharmacological treatment for osteoporosis or bone density which in the medical opinion of the surgeon precludes operation or contraindicates instrumentation.
✕. Paget disease, osteomalacia, or any other metabolic bone disease other than osteoporosis.
✕. Active malignancy that includes a history of any invasive malignancy (except nonmelanoma skin cancer), unless previously treated with curative intent and with no clinical signs or symptoms of the malignancy for \> 5 years.
✕. Severe cervical instability based on radiographic exam (whereby an anterior and posterior reconstructive procedure is indicated).