Observational Study to Evaluate the STALIF® C FLX, STALIF® M FLX, STALIF® L FLX Cages and FORTOS-C®
Running, not enrolling
Conditions studied: Degenerative Cervical Disc Disease, Degenerative Lumbar Diseases
In brief
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.
Key facts
- Study ID
- NCT06876311
- Run by
- Silony Medical GmbH
- People needed
- 100
- Starts
- 2025-03-04
- Expected to finish
- 2025-05-30
- Last updated by the study team
- 2025-03-14
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Relative and absolute contraindications according to IFU
Where it is running
- Golden State Orthopedics and Spine — San Ramon, California, United States
Full record on ClinicalTrials.gov
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