ISRCTN63972735
Active, not recruiting
Phase 4
Prospective evaluation of clinical and radiographic outcomes after anterior cervical interbody fusion surgery using a TRYPTIK® Ti-Life cage
Spineart (Switzerland)0 sites96 target enrollmentOctober 4, 2021
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Radiculopathy and/or myelopathy, secondary to cervical degenerative disc disease and/or spondylosis, and for patients who are resistant to conservative management
- Sponsor
- Spineart (Switzerland)
- Enrollment
- 96
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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 IF
Outcomes
Primary Outcomes
Not specified
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