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

March 13, 2025 updated by: Silony Medical GmbH

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®

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Ramon, California, United States, 94583
        • Golden State Orthopedics and Spine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient population is defined by Inclusion and exclusion criteria.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
FORTOS-C
Patients treated with FORTOS-C
Device: Anterior Cervical Interbody Fusion
Standard Anterior Cervical Interbody Fusion with Stand-alone Cervical Cages
STALIF C FLX
Patients treated with STALIF C FLX
Device: Anterior Cervical Interbody Fusion
Standard Anterior Cervical Interbody Fusion with Stand-alone Cervical Cages
STALIF M FLX
Patients treated with STALIF M FLX
Device: Anterior lumbar Interbody Fusion
Standard Anterior Lumbar Interbody Fusion with Stand-Alone Lumbar Cages
STALIF L FLX
Patients treated with STALIF L FLX
Device: Lateral Lumbar Interbody Fusion
Standard Lateral Lumbar Interbody Fusion with Stand-alone Lumbar cage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck Disability Index
Time Frame: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative

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
Time Frame: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
The Visual Analogue Scale (VAS) is usually quantified from 0 to 10, where 0 means 'no pain' and 10 means 'strongest pain imaginable'.
Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Radiological assessment
Time Frame: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
  • Implant migration/ Subsidence/ Screw Back-out
  • Bone Fusion at latest follow-up
Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Complications
Time Frame: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Intraoperative and postoperative complications, revisions, and (serious) adverse events
Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Silony Medical GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2025

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

May 30, 2025

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • TDI_2023_004_2.1_103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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