NCT06106061尚未招募不适用
Effectiveness and Safety of the Facet Fixation (FFX®) Implant in the Treatment of Degenerative Lumbar Spinal Stenosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- SC Medica
- 入组人数
- 320
- 主要终点
- Proportion of subjects with composite clinical success (CCS)
研究概览
简要总结
This is a prospective, multicentric, comparative, randomised-controlled study to evaluate the safety and efficacy of the Facet Fixation implant.
The main objective is to evaluate the effectiveness of spinal decompression associated with FFX® implants compared to spinal decompression alone in treating lumbar spinal stenosis after 2 years of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years.
- •Radiographic confirmation of clinical symptoms of at least moderate degenerative spinal stenosis, of 1 to 3 adjacent segments in the L1-S1 region with the need for surgical decompression.
- •Radiographic confirmation of no translational instability in main segment as well as in adjacent segments (dynamic translational instability ≤3 mm);
- •Visual analogue scale (VAS) back pain score ≥ 50 mm (on a 100-mm scale).
- •Minimum of 3 months of conservative therapy without improvement of symptoms.
- •Mental & physical ability of the subject to follow the protocol (i.e., compliance with time schedule & treatment plan, able to fill in questionnaire & to undergo further study procedures).
- •Personally signed and dated informed consent document prior to any study-related procedures indicating that the subject has been informed of all pertinent aspects of the clinical investigation.
排除标准
- •Prior lumbar spine surgery.
- •Radiographically confirmed damage of a vertebral body (e.g., osteoporotic compression fracture or because of tumours), at any lumbar level.
- •Isthmic or degenerative spondylolisthesis (anterolisthesis; retrolisthesis ≥ grade II) or spondylolysis (pars fracture).
- •Degenerative lumbar scoliosis (Cobb angle > 25°).
- •Adipositas (obesity); defined as a body mass index (BMI) >
- •Pregnancy, or wish to get pregnant during the course of the study, or breastfeeding.
- •Known allergy or sensitivity to titanium, titanium alloys, or MRI contrast agents.
- •Active or chronic infection-systemic or local.
- •History of significant peripheral neuropathy.
- •Significant peripheral vascular disease (e.g., with diminished dorsalis pedis or posterior tibial pulses).
- •Paget disease, osteomalacia or other metabolic bone disorders.
- •Cauda equina syndrome.
- •Known or documented history of transmissible disease, including AIDS, HIV and active hepatitis.
- •More than 3 vertebral levels requiring surgery.
- •Disc herniation at any lumbar level requiring surgical intervention.
- •Known osteoporosis (bone mineral density, BMD < 120 mg/cm3).
- •Chronically taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids), not including a Medrol (methylprednisolone) dose pack.
- •Fixed and complete motor, sensory, or reflex deficit.
- •Rheumatoid arthritis or other autoimmune diseases.
- •Active malignancy: a subject with a history of any invasive malignancy (except non-melanoma skin cancer) unless he/she has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least 5 years. Subjects with a primary bony tumour are excluded as well.
- •Subject with a history of substance abuse (e.g., recreational drugs, narcotics, or alcohol).
- •Bone destruction, demineralisation or any affection potentially affecting fixation of an implant.
- •Spondylodiscitis or spine tumour.
- •Currently seeking or receiving workman's compensation.
- •In active spinal litigation.
- •Subjects who participate(d) in another clinical trial (within the last 4 weeks) that might influence the safety & effectiveness assessment of this trial.
- •Subjects who are lawfully kept in an institution.
- •Subject who, in the opinion of the investigator, will be inappropriate for inclusion in this clinical trial or who will not comply with requirements of the study.
- •Subject under supervision or legal guardianship, or judicial protection.
- •Subject deprived of liberty by judicial or administrative decision.
- •Subject not covered by a social security scheme.
结局指标
主要结局
Proportion of subjects with composite clinical success (CCS)
时间窗: 2 years
The CCS will be considered as met if ALL of the following criteria are satisfied for a subject: * Back pain score (VAS) decrease by more than 20 mm (on 100-mm scale) * No secondary surgical intervention at the index level (excluding wound problems) * No non-surgical lumbar treatment of interest at any lumbar level
次要结局
未报告次要终点
研究者
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