Triadyme-C, a Polycrystalline Diamond Compact Cervical Disc Replacement (cTDR)
Germany100 participantsStarted 2016-11
Plain-language summary
This Post Market Clinical Follow-up (PMCF) is conducted to collect clinical and radiographic outcome information on patients suffering from intractable symptomatic cervical disc disease requiring 1- or 2-level reconstruction of the disc from C3-C7, after being treated with the Triadyme-C polycrystalline diamond compact cervical disc replacement.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 1- or 2-level cTDR surgery between C3 and C7
✓. Age ≥ 18 years
✓. Skeletally mature patient
✓. Patient suffers from intractable symptomatic cervical disc disease (SCDD) with neck or arm (radicular) pain and/or a functional/neurological deficit
✓. At least one of the following conditions must be present and confirmed by radiographic (CT, MRI, x-ray, etc.) studies: herniated nucleus pulposus, spondylosis (indicated by the presence of osteophytes), or loss of disc height.
✓. At least six weeks of non-operative treatment for SCDD has been tried and failed prior to implantation
✓. Psychosocially, mentally, and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
✓. Patient signed Informed Consent
Exclusion criteria
✕. Active systemic infection or infection localized to the site of implantation
✕. Allergy or sensitivity to the implant materials
✕. Osteoporosis, defined as a Dual-energy X-ray Absorptiometry (DXA) bone mineral density T-score equal to or less than -2.5
✕. Marked cervical instability on radiographs (e.g., radiographic signs of subluxation greater than 3.5 mm or angulation of the disc space more than 11 degrees greater than adjacent segments)
✕. Severe spondylosis characterized by bridging osteophytes or an absence of motion (less than 2 degrees)
✕. Significant cervical anatomical deformity or compromised vertebral bodies at the index level (e.g. ankylosing spondylitis, rheumatoid arthritis, or compromise due to current or past trauma)
✕. Significant kyphotic deformity or significant reversal of lordosis
✕. Previous cervical spinal surgery, other than discectomy at the levels to be operated on