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

N/AActive Not RecruitingNCT06876311

Silony Medical GmbH100 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Degenerative Cervical Disc Disease Degenerative Lumbar Diseases

Interventions

Anterior Cervical Interbody FusionDEVICE

Standard Anterior Cervical Interbody Fusion with Stand-alone Cervical Cages

Anterior lumbar Interbody FusionDEVICE

Standard Anterior Lumbar Interbody Fusion with Stand-Alone Lumbar Cages

Lateral Lumbar Interbody FusionDEVICE

Standard Lateral Lumbar Interbody Fusion with Stand-alone Lumbar cage

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Golden State Orthopedics and Spine

San Ramon, California, United States

Outcomes

Primary Outcomes

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%).

Time frame: 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.

Time frame: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative

Secondary Outcomes

Visual Analogue Scale

The Visual Analogue Scale (VAS) is usually quantified from 0 to 10, where 0 means 'no pain' and 10 means 'strongest pain imaginable'.

Time frame: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative

Radiological assessment

* Implant migration/ Subsidence/ Screw Back-out * Bone Fusion at latest follow-up

Time frame: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative

Data from ClinicalTrials.gov

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