NCT05633888招募中不适用
Prospective, Multi-Center, Single Arm Post-Market Feasibility Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 12
- 主要终点
- Proportion of subjects that meet the definition of Subject Success at 6 months post-procedure
研究概览
简要总结
The purpose of this study is to evaluate the outcomes of patients with sacroiliac joint pain treated with the CATAMARAN SI Joint Fusion System.
详细描述
This is a multi-center post-market study to evaluate the clinical outcomes of patients with sacroiliac joint disruptions or degenerative sacroiliitis treated with the CATAMARAN SI Joint Fusion System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis based on ALL of the following:
- •Patient has pain at or close to the posterior superior iliac spine (PSIS) with possible radiation into buttocks, posterior thigh or groin and can point with a single finger to the location of pain (Fortin Finger Test), and
- •Patient has at least 3 of 5 physical examination maneuvers specific for SI joint pain (Fabers, Compression, Distraction,Thigh thrust, Gaenslen's test, and/or Sacral thrust test), and
- •Patient has improvement in lower back pain VAS of at least 50% of the pre injection VAS after fluoroscopic controlled injection of local anesthetic into affected SI joint(s) (including previous documented test <6 months ago)
- •Patient has failed conservative care (non-surgical) > 6 months
- •Patient has a pre-operative Oswestry Disability Index score > 30%
- •Patient has a pre-operative SI joint pain score of > 50 on a 0-100 mm visual analog scale (VAS)
- •Patient, or authorized representative, signs a written Informed Consent form to participate in the study
- •Patient is willing and able to complete study follow-up requirements
排除标准
- •Planned bi-lateral SI joint fixation
- •Severe lower back pain due to other causes, such as lumbar disc degeneration, lumbar disc herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet degeneration, and lumbar vertebral body fracture (this is done by physical exam, medical history, and MRI/CT/X-ray as required)
- •Other known sacroiliac pathology such as: sacral dysplasia, inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA- associated spondyloarthropathy), tumor, acute fracture, crystal arthropathy
- •History of recent (<1 year) fracture of the pelvis with documented malunion, non-union of sacrum or ilium or any type of internal fixation of the pelvic ring
- •Severe osteoporosis
- •Paget's disease, osteomalacia, osteomalacia or other metabolic bone disease
- •Any condition or anatomy that makes treatment with the CATAMARAN SI Joint Fusion System infeasible including deformity
- •Known allergy to titanium or titanium alloys
- •Morbid obesity
- •Active malignancy: a history of any invasive malignancy (except non-melanoma skin cancer), unless the subject has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least five years
- •Patient has systemic infection or active infection at the treatment site
- •Chronic rheumatologic condition (e.g., rheumatoid arthritis)
- •Patient has uncontrolled diabetes
- •Patient is currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation
- •Prominent neurologic condition that would interfere with physical therapy
- •Patient is pregnant or wishes to become pregnant in the next two years
- •Patient is not likely to comply with the follow-up evaluation schedule
- •Patient is participating in a clinical trial of another investigational drug or device in which the primary endpoint has not occurred
- •Patient has a psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation
- •Known or suspected drug or alcohol abuse
- •Patient is a prisoner or a ward of the state
研究组 & 干预措施
CATAMARAN SI Joint Fusion System
Experimental
Placement of the Catamaran Fixation Device
干预措施: CATAMARAN SI Joint Fusion System (Device)
结局指标
主要结局
Proportion of subjects that meet the definition of Subject Success at 6 months post-procedure
时间窗: 6 months post procedure
Change from baseline in VAS SI joint pain score to be reduced by at least 20 mm, Lack of device-related serious adverse events, Absence of neurologic worsening related to the sacral spine compared to baseline (unless attributable to a concurrent medical condition or other cause unrelated to the device and/ or study procedure), and Absence of surgical re-intervention (removal, revision, reoperation, or supplemental fixation) for SI joint pain.
次要结局
未报告次要终点
研究者
研究点 (12)
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