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NCT Number: NCT06876311

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Degenerative Cervical Disc Disease Degenerative Lumbar Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Golden State Orthopedics and Spine

San Ramon, California, 94583, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anterior cervical interbody fusion

Device

Standard Anterior Cervical Interbody Fusion with Stand-alone Cervical Cages

Anterior lumbar Interbody Fusion

Device

Standard Anterior Lumbar Interbody Fusion with Stand-Alone Lumbar Cages

Lateral Lumbar Interbody Fusion

Device

Standard Lateral Lumbar Interbody Fusion with Stand-alone Lumbar cage

Primary outcomes

  1. 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%).

  2. 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.

Secondary outcomes

  1. 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'.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Silony Medical GmbH

Industry

Registry information

Official study title

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®

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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