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®
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Neck Disability Index
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Relative and absolute contraindications according to IFU
结局指标
主要结局
Neck Disability Index
时间窗: 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%).
Oswestry Disability Index
时间窗: 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.
次要结局
- 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)