Prospective Multi-Center Patient Registry for Patients With Elbow, Hip, and Calcific Shoulder Tendinosis Treated Utilizing the TenJet Hydroresection System
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 600
- 试验地点
- 6
- 主要终点
- Return to function (Elbow #2)
研究概览
简要总结
Treatment of recalcitrant tendinopathy remains a clinical challenge for physicians without a minimally invasive treatment option that can consistently provide patients with a long-term relief from chronic pain and ability to return to function.
Surgical debridement of degenerative tendon tissue has long been the standard of care to treat degenerative tendon pathology once all conservative or minimally invasive treatment options have failed.
Ultrasound guided tenotomy is an emerging treatment option with the potential to address the underlying degenerative, diseased tissue, by selectively resecting and removing the tissue in a minimally invasive manner. Additionally, with the availability of in-office diagnostic ultrasound imaging, physicians now have an opportunity to evaluate and classify underlying tendon pathology during a clinical exam. This study is to evaluate outcomes in patients presenting with a clinical history of recalcitrant tendinopathy with confirmed diagnosis of degenerative tendinosis using diagnostic ultrasound imaging or MRI.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient is 18 - 70 years of age
- •Chronic tendon pain ≥ 3 months duration
- •History and clinical examination consistent with tendinosis
- •Sonographic or MRI confirmation of tendinosis
- •3 months of conservative treatment
- •Patient is willing and able to provide informed consent and comply with the study protocol
排除标准
- •Full thickness tear of the tendon
- •Unable to withhold anticoagulants 7 days prior to the procedure.
- •Use above 81mg/day of acetylsalicyclic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 7 days of treatment
- •Steroid, PRP, Stem cell or biologic injections within 3 months of the study procedure date
- •Needle tenotomy, Tenex, or surgical interventions within 6 months of study procedure date
- •Active local or systemic infection requiring antiviral, antibacterial or antifungal treatment
- •Chronic conditions such as CRPS or fibromyalgia that might affect pain symptoms.
结局指标
主要结局
Return to function (Elbow #2)
时间窗: 2 years
This will be measured in participants undergoing treatment for Elbow Tendinopathy using the Patient-Rated Tennis Elbow Evaluation (PRTEE) survey
Return to function (Elbow #1)
时间窗: 2 years
This will be measured in participants undergoing treatment for Elbow Tendinopathy using the Mayo Elbow Performance Score (MEPS)
Pain reduction
时间窗: 2 years
Using the Visual Analog Scale for Pain (VAS) participants will be asked to report their pain score after surgery
Return to function (Elbow #3)
时间窗: 2 years
This will be measured in participants undergoing treatment for Elbow Tendinopathy using the Quick Disability Arm, Shoulder and Hand (QDASH) survey
Return to function (All cohorts)
时间窗: 2 years
This will be measured in participants undergoing treatment for Elbow, Hip and Shoulder Tendinopathy using the Short Form Health Survey (SF-12) survey
Return to Function (Hip)
时间窗: 2 years
This will be measured in participants undergoing treatment for Hip Tendinopathy using the Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) survey
Return to Function (Shoulder)
时间窗: 2 years
This will be measured in participants undergoing treatment for Shoulder Tendinopathy using the American Shoulder \& Elbow Score (ASES) survey
次要结局
未报告次要终点