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

Silony Medical

Status: Active, not recruiting

Conditions: Degenerative Cervical Disc Disease; Degenerative Lumbar Diseases

Treatments: Device: Anterior lumbar Interbody Fusion; Device: Anterior Cervical Interbody Fusion; Device: Lateral Lumbar Interbody Fusion

Study type: Observational

Funder types: Industry

Identifiers

NCT06876311

TDI_2023_004_2.1_103

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No 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

Trial design

100 participants in 4 patient groups

FORTOS-C

Description:

Patients treated with FORTOS-C

Treatment:

Device: Anterior Cervical Interbody Fusion

STALIF C FLX

Description:

Patients treated with STALIF C FLX

Treatment:

Device: Anterior Cervical Interbody Fusion

STALIF M FLX

Description:

Patients treated with STALIF M FLX

Treatment:

Device: Anterior lumbar Interbody Fusion

STALIF L FLX

Description:

Patients treated with STALIF L FLX

Treatment:

Device: Lateral Lumbar Interbody Fusion