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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-04

Study Completion Date

2025-05-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Degenerative Cervical Disc Disease Degenerative Lumbar Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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FORTOS-C

Patients treated with FORTOS-C

Anterior Cervical Interbody Fusion

Intervention Type DEVICE

Standard Anterior Cervical Interbody Fusion with Stand-alone Cervical Cages

STALIF C FLX

Patients treated with STALIF C FLX

Anterior Cervical Interbody Fusion

Intervention Type DEVICE

Standard Anterior Cervical Interbody Fusion with Stand-alone Cervical Cages

STALIF M FLX

Patients treated with STALIF M FLX

Anterior lumbar Interbody Fusion

Intervention Type DEVICE

Standard Anterior Lumbar Interbody Fusion with Stand-Alone Lumbar Cages

STALIF L FLX

Patients treated with STALIF L FLX

Lateral Lumbar Interbody Fusion

Intervention Type DEVICE

Standard Lateral Lumbar Interbody Fusion with Stand-alone Lumbar cage

Interventions

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Anterior Cervical Interbody Fusion

Standard Anterior Cervical Interbody Fusion with Stand-alone Cervical Cages

Intervention Type DEVICE

Anterior lumbar Interbody Fusion

Standard Anterior Lumbar Interbody Fusion with Stand-Alone Lumbar Cages

Intervention Type DEVICE

Lateral Lumbar Interbody Fusion

Standard Lateral Lumbar Interbody Fusion with Stand-alone Lumbar cage

Intervention Type DEVICE

Eligibility Criteria

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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