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

NCT06876311 | Active Not Recruiting FDA Device

• 1 other identifier: TDI_2023_004_2.1_103
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Degenerative Cervical Disc Disease; Degenerative Lumbar Diseases

Outcome Measures

Primary Outcomes (2)

• Neck Disability Index

  The Neck Disability Index (NDI) has 10 items that cover various aspects of daily functioning, such as pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Scoring: Each question contains six answer choices, scored from 0 (no disability) to 5 (complete disability). All section scores are then totaled. Scoring is reported on a 0-50 scale, 0 being the best possible score and 50 being the worst. Alternately, the score can be reported from 0-100. The score is often reported as a percentage (0-100%).

  Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative

• Oswestry Disability Index

  The Oswestry Disability Index (ODI) is used to measure the extent of pain-related functional limitations in people with low back pain. The questionnaire provides the user with information about the general functional ability of a patient with low back pain in everyday life. Six response options are available for the following items: pain intensity, self-care (washing, dressing), lifting, locomotion, sitting or standing, sleeping, sex life, social life and travel/transportation. The first answer option (score 0) means that there are no pain-related restrictions, while the sixth answer option (score 5) indicates the greatest perceived restriction of an activity due to pain.

  Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative

Secondary Outcomes (3)

• Visual Analogue Scale

  Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative

• Radiological assessment

  Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative

• Complications

  Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative

Study Arms (4)

FORTOS-C

Patients treated with FORTOS-C

Device: Anterior Cervical Interbody Fusion

STALIF C FLX

Patients treated with STALIF C FLX

Device: Anterior Cervical Interbody Fusion

STALIF M FLX

Patients treated with STALIF M FLX

Device: Anterior lumbar Interbody Fusion

STALIF L FLX

Patients treated with STALIF L FLX

Device: Lateral Lumbar Interbody Fusion

Interventions

Anterior Cervical Interbody Fusion DEVICE

Standard Anterior Cervical Interbody Fusion with Stand-alone Cervical Cages

FORTOS-C; STALIF C FLX

Anterior lumbar Interbody Fusion DEVICE

Standard Anterior Lumbar Interbody Fusion with Stand-Alone Lumbar Cages

STALIF M FLX

Lateral Lumbar Interbody Fusion DEVICE

Standard Lateral Lumbar Interbody Fusion with Stand-alone Lumbar cage

STALIF L FLX

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient population is defined by Inclusion and exclusion criteria.

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

Sponsors & Collaborators

• Silony Medical GmbH: lead

Study Sites (1)

Golden State Orthopedics and Spine

San Ramon, California, 94583, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 14, 2025
• Study Start: March 4, 2025
• Primary Completion: April 30, 2025
• Study Completion: May 30, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)