Official Title
Sponsor-initiated, Retrospective, Monocentric, Non-interventional Clinical Observational Study to Evaluate the STALIF® C FLX, STALIF® M FLX, STALIF® L FLX Cages and FORTOS-C®
Brief Summary

Post-operative clinical outcome data on the devices used to treat spinal diseases arecollected and evaluated in order to analyze the safety and performance of the implantsused.

Detailed Description

Not Provided

Active, not recruiting
Degenerative Cervical Disc Disease
Degenerative Lumbar Diseases

Device: Anterior Cervical Interbody Fusion

Standard Anterior Cervical Interbody Fusion with Stand-alone Cervical Cages

Device: Anterior lumbar Interbody Fusion

Standard Anterior Lumbar Interbody Fusion with Stand-Alone Lumbar Cages

Device: Lateral Lumbar Interbody Fusion

Standard Lateral Lumbar Interbody Fusion with Stand-alone Lumbar cage

Eligibility Criteria

Inclusion Criteria:

- 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 Criteria:

- Relative and absolute contraindications according to IFU

Eligibility Gender
All
Eligibility Age
Minimum: 21 Years ~ Maximum: N/A
Countries
United States
Locations

Golden State Orthopedics and Spine
San Ramon, California, United States

Not Provided

Silony Medical GmbH
NCT Number