Observational Study to Evaluate the STALIF® C FLX, STALIF® M FLX, STALIF® L FLX Cages and FORTOS-C®

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®

NCT06876311•Silony Medical GmbH

View on ClinicalTrials.gov

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

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Golden State Orthopedics and Spine

San Ramon, California, United States

Key Dates

Start Date

March 4, 2025

Primary Completion Date

April 30, 2025

Completion Date

May 30, 2025

Last Updated

March 14, 2025

Enrollment

100

ESTIMATED participants

Conditions

Degenerative Cervical Disc DiseaseDegenerative Lumbar Diseases

Interventions

Anterior Cervical Interbody Fusion

DEVICE

Anterior lumbar Interbody Fusion

DEVICE

Lateral Lumbar Interbody Fusion

DEVICE

Efficacy and Safety of Novosis Putty for Degenerative Lumbar Disease

NCT06715345

Degenerative Lumbar Diseases

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TERMINATEDNA

INFUSE ® Bone Graft/CORNERSTONE-SR® Allograft Ring/ATLANTIS® Anterior Cervical Plate System Pivotal Trial

NCT01491477

Degenerative Cervical Disc Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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