Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Radiographic Evaluation
研究概览
简要总结
The objective of this study is to gather clinical data on SI-LOK® for the treatment of sacroiliac joint dysfunction.
The purpose of this prospective study is to evaluate clinical and radiographic outcomes, intra-operative parameters, patient satisfaction and work status following a procedure using SI-LOK® for treatment of sacroiliac joint dysfunction with a minimum of three screws.
详细描述
Clinical Research Forms will be completed at all pre-op, intra-op and post-op visits by either the surgeon, clinical coordinator or patient.
Forms completed by patients will be checked, initialed and dated by the site coordinator.
Data collected will be presented as mean +/- standard deviation. Statistical significance will be evaluated at the P < 0.05 significance level.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A maximum age of 70 years
- •Diagnosis of SIJ dysfunction
- •Ability to provide Informed Consent for study participation and to return for all follow-up visits
排除标准
- •Previous documentation of osteopenia or osteomalacia
- •History of metabolic bone disease (e.g. diabetes requiring daily insulin)
- •Diagnosis of a condition or requires postoperative medication(s), which may interfere with bony/soft tissue healing
- •Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)
- •History of substance abuse (drugs or alcohol)
- •Condition that would preclude completing patient self assessment questionnaires
- •Mentally incompetent or prisoner
- •Currently a participant in another study
结局指标
主要结局
Radiographic Evaluation
时间窗: 2 years
Fusion Assessment Radiolucency
次要结局
- Hospitalization Data(Intra-Operative)