Status:
ACTIVE_NOT_RECRUITING
Observational Study to Evaluate the STALIF® C FLX, STALIF® M FLX, STALIF® L FLX Cages and FORTOS-C®
Lead Sponsor:
Silony Medical GmbH
Conditions:
Degenerative Cervical Disc Disease
Degenerative Lumbar Diseases
Eligibility:
All Genders
21+ years
Brief Summary
Post-operative clinical outcome data on the devices used to treat spinal diseases are collected and evaluated in order to analyze the safety and performance of the implants used.
Eligibility Criteria
Inclusion
- \- Indications according to IFU
- Surgical implantation of STALIF® C or M FLX device for 1 or 2 levels between:
- STALIF® C FLX: C2-T1 (cervical)
- STALIF® M FLX: L2-S1 (lumbar)
- STALIF® L FLX: L2-L5 (lumbar)
- Surgical implantation of FORTOS-C® for the fusion of up to 3 levels between:
- FORTOS-C®: C2 - T1 (cervical)
- Age: ≥ 21 years
- For the evaluation of the questionnaires (NDI or ODI, VAS neck and VAS arm or VAS leg and VAS back), only patients with the questionnaire available at the time of admission (pre-op) and at least at 12-months FU will be included
Exclusion
- Relative and absolute contraindications according to IFU
Key Trial Info
Start Date :
March 4 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06876311
Start Date
March 4 2025
End Date
May 30 2025
Last Update
March 14 2025
Active Locations (1)
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1
Golden State Orthopedics and Spine
San Ramon, California, United States, 94583