NCT03487250已完成不适用
Prospective Multi-Center Evaluation of Percutaneous Ultrasound Guided Elbow Tenotomy (PUGET) Using the HydroCision TenJet HydroSurgery System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 6
- 主要终点
- Change in elbow pain using Visual Analog Scale (VAS)
研究概览
简要总结
To evaluate the acute and long-term clinical outcomes of tenotomy with the TenJet System in patients with elbow tendinosis.
详细描述
This is a prospective, non-randomized, single arm post-marketing clinical study of patients undergoing percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System to treat elbow tendinosis. Patients will be followed for a maximum of 12 months post-procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 is > 18 years of age
- •Chronic lateral or medial elbow pain > 3 month duration
- •History and clinical examination consistent with lateral or medial epicondylitis
- •Sonographic evidence of medial or lateral elbow tendinosis as evidenced by
- •tendon thickening and hypoechogenicity,
- •with or without hypervascularity on Doppler examination and,
- •with or without cortical irregularities, Or MRI findings consistent with lateral or medial tendinosis, with or without intrasubstance tear.
- •> 3 months of non-operative treatment that included
- •nonsteroidal anti-inflammatory drugs
- •activity modification
- •physical therapy
- •elbow straps
- •With or without previous steroid injections, protein rich plasma injections, or stem cell injections
- •Patient is willing and able to provide informed consent and comply with the study protocol
排除标准
- •Documented ipsilateral upper extremity musculoskeletal condition (other than elbow tendinosis in the same arm on the opposite side)
- •Bleeding disorders and/or current use of anti-coagulants with the inability to withhold anticoagulants for required time prior to procedure
- •Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 7 days of treatment
- •Steroid injection within 4 weeks of the study procedure
- •Active local or systemic infection
- •Patient found to have further degenerative changes of the elbow contributing to pain, such as cartilage thinning, loose body, or evidence of tendinosis other than medial or lateral, including triceps or ulnar collateral ligament.
- •Patient is known or suspected to be pregnant
结局指标
主要结局
Change in elbow pain using Visual Analog Scale (VAS)
时间窗: Up to 12 months
Change in elbow pain VAS compared to baseline
次要结局
- Pain medication usage(Up to 12 months)
- Change in Elbow Function using the Patient-Rated Elbow Evaluation Questionnaire (PREE)(Up to 12 months)
研究者
研究点 (6)
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