Prospective, Multi-Center, Single Arm Post-Market Study of the Tenon Medical CATAMARAN™ SI Joint Fusion System.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Radiographic Fusion
研究概览
简要总结
The objective of this study is to evaluate 6-to-12-month radiographic outcomes of patients with sacroiliac joint disruptions or degenerative sacroiliitis that have already undergone treatment with the CATAMARAN SI Joint Fusion System. In addition, retrospective and prospective clinical outcomes will be evaluated.
详细描述
Patients with degenerative sacroiliitis or sacroiliac joint disruption who already had the CATAMARAN Fixation Device implanted between 6 and 12 months will be asked to return for follow-up visit to evaluate clinical outcomes and undergo a high resolution pelvic CT-Scan to assess fusion. Additionally, retrospective clinical outcomes will be collected from the medical records.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient >18 years of age at time of treatment with the CATAMARAN SI Joint Fusion System
- •Patient implanted with the CATAMARAN Fixation Device within the last 12 months
- •Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis
- •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
- •Known or suspected active drug or alcohol abuse
- •Previously diagnosed osteoporosis (defined as prior T-score <-2.5 or history of osteoporotic fracture) or prior/current use of drug therapy for osteoporosis.
- •Prior fracture of any bone related to cancer/tumor (i.e., pathologic fracture)
- •Prior diagnosis of tumor in sacrum or ilium
- •Unstable fracture of sacrum and or ilium involving the targeted SIJ
- •Osteomalacia or other metabolic bone disease
- •Use of medications known to have detrimental effects on bone quality and soft-tissue healing
- •Patient is pregnant or wishes to become pregnant during the study period
- •Patient is not likely to comply with the follow-up evaluation schedule
- •Patient is a prisoner or a ward of the state
结局指标
主要结局
Radiographic Fusion
时间窗: 6-12 month post CATAMARAN Fixation Device implantation
The primary endpoint is the proportion of subjects that demonstrate radiographic fusion assessed by CT-Scan, as evaluated by an Independent Radiologist.
次要结局
- Device Status(6-12 months post-op)
- Neurologic worsening related to the sacral spine(6-12 months post-op)
- Serious device related adverse events(6-12 months post-op)
- Surgical re-intervention for SI joint pain(6-12 months post-op)