Radiculopathy and/or myelopathy, secondary to cervical degenerative disc disease and/or spondylosis, and for patients who are resistant to conservative management Musculoskeletal Diseases Radiculopathy, Disease of spinal cord, unspecified, Spondylosis
Conditions
Interventions
TRYPTIK Ti is intended for use during Anterior Cervical Discectomy and Fusion (ACDF), between C3 and C7, and up to four consecutive levels. It is indicated for the surgical treatment of radiculopathy
Sponsors
Spineart (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who will receive at least one and up to four TRYPTIK® Ti-Life cages between C3 and C7 levels 2. Patient willing and able to comply with follow-up schedule and filling out questionnaires 3. Written voluntary informed consent signed
Exclusion criteria
Exclusion criteria: 1. Patients under 18 years of age 2. Patients in whom cervical/radicular pain could be attributable to a diagnosis other than degenerative disease (i.e., tumors, congenital, rheumatoid disease, or infection) 3. Patients who have a contraindication listed in the IFU
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fusion rates assessed by the use of reconstructed axial and coronal fine-cut computed tomography scans (CT scan) at 6-month postoperative visits. Assessment will be repeated at 12 and 24 months only if solid fusion is not reached on the previous assessment. Fusion will be assessed as solid fusion, fibrous union, or non-union by an independent orthopedic or neurosurgeon and a radiologist consultant who will interpret the CT scans. A third independent orthopedic or neurosurgeon consultant will adjudicate differences in fusion findings. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intervertebral foraminal height measured on radiographs, defined as the distance between the lower margin of the upper pedicle to the upper margin of the lower pedicle, assessed immediately postoperatively and at 6-12 weeks, 6, 12 and 24 months post-operatively compared to the preoperative measures 2. Cervical and segmental lordosis assessed immediately postoperatively and at 6-12 weeks, 6, 12 and 24 months post-operatively compared to the preoperative measures. Lateral radiographs of the cervical spine will be used to measure cervical and segmental lordosis by means of the Cobb angle. Segmental sagittal alignment is defined as the angle between the cranial and caudal endplates of the vertebrae located above and below the affected segment, and cervical sagittal alignment from C1 to C7. Both measures provide positive and negative values indicating lordotic or kyphotic angulation, respectively. 3. Subsidence rate balance assessed at 6-12 weeks, 6, 12 and 24 months post-operatively compared to the immediate postoperative measure. Implant subsidence will be evaluated by means of lateral radiographs of the cranial and caudal endplates of the segments located above and below the operated segments, respectively. Measurement of the distance between the superior endplate of the superior vertebral body and the inferior endplate of the inferior vertebral body are based on the anterior (AntEH) and posterior endplate height (PostEH). Based on location, implant subsidence will be classified according to four directions of implant sinkage: anterior, posterior, cranial, and caudal. Subsidence will be considered mild if the loss of height is under 3 mm, and severe if the loss is over 3 mm 4. Patient-reported outcomes: 4.1. Functional capacity assessed by the Neck Disability Index (NDI) at baseline (preoperative status) to 6-12 weeks, 6-, 12- and 24-months postoperative 4.2. Health-related quality of life assessed by the SF-12 at baseline (preoperative status) to 6-12 weeks, 6-, 1 | — |
Countries
England, Spain, United Kingdom
Outcome results
None listed