A Prospective Randomized Comparison Study on the Effects of Percutaneous Ultrasonic Tenotomy Versus Leukocyte-Rich Platelet Rich Plasma for Refractory Gluteal Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Change in Numeric Pain Rating Scale
研究概览
简要总结
The primary objective of this study is to evaluate safety and effectiveness of both a single percutaneous ultrasonic tenotomy or a single injection of LR-PRP in gluteal tendinopathy. Effectiveness will be demonstrated in a superiority trial design by comparing improvement in pain and function after a single percutaneous ultrasonic tenotomy versus a single injection of LR-PRP in refractory gluteal tendinopathy that has failed conservative management. The investigators hypothesize that both procedures will show improvement to pain and function from baseline to 24 weeks and improvement will remain at 48 weeks follow-up. The investigators propose to test this hypothesis with a series of randomized cases of gluteal tendinopathy treated with one of the proposed treatment arms and evaluate at specified intervals with validated clinical outcome measures.
详细描述
Aim of the Study:
To investigate the safety and effectiveness of a single percutaneous ultrasonic tenotomy procedure versus a single injection of autologous leukocyte-rich platelet rich plasma (LR-PRP) in subjects with symptomatic gluteal tendinopathy which has been refractory to conservative treatment
Hypothesis of the Study:
The hypothesis of this study is that subjects with symptomatic gluteal tendinopathy (defined as <50% partial-thickness tear of either the gluteus medius or gluteus minimus tendons on MRI or US) who receive either a single percutaneous ultrasonic tenotomy or a single injection of LR-PRP will demonstrate less pain and improved hip function compared to pre-treatment baseline.
Primary Objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Unable to blind procedures as they require different types of devices, procedures and settings.
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
- 否
入选标准
- •Males and Females 18 - 70 years of age (inclusive)
- •Clinical symptoms for a minimum of three months
- •Subjects have a baseline pain score of > 3
- •Partial-thickness gluteal tendon tear (gluteus medius or gluteus minimus) defined as <50% partial-thickness tear of either tendon or imaging abnormalities consistent with tendinosis on a 3 Tesla MRI or diagnostic ultrasound within the last 3 months, as determined by the Investigator
排除标准
- •Age < 18 or > 70
- •Corticosteroid injection in the index gluteal bursae within the last 3 months
- •Subjects who have received more than one (1) previous corticosteroid injections or percutaneous tenotomy procedure or any biologic treatment in the index gluteal bursae at any point in the past.
- •Severe arthrosis of the femoral-acetabular joint
- •A high-grade gluteal tendon tear (>50% partial-thickness tear)
- •Previous hip surgery on the affected side
- •Previous or current history of labral pathology on the affected side
- •Lumbar radiculopathy impacting the index hip
- •History of systemic malignant neoplasms within the last 5 years
- •Malignant or local neoplasm within the last 6 months or any history of local neoplasm at the site of administration (on the affected side)
- •Receiving immunosuppressive therapy
- •Active regimen of chemotherapy or radiation-based treatment
- •Allergy to sodium citrate or any "caine" type of local anesthetic
- •Pregnancy
- •Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. (Non-interventional observational studies are not exclusionary.)
- •Active workman's compensation case in progress
研究组 & 干预措施
Leukocyte-Rich Platelet-Rich Plasma (LR-PRP)
LR-PRP will be administered via usual protocol with venous blood draw and concentration via centrifugation. The LR-PRP will be injected under ultrasound guidance into the gluteus minimus and gluteus medius tendons, enthesis and surrounding bursae.
干预措施: Leukocyte-Rich Platelet-Rich Plasma (Drug)
Percutaneous Ultrasonic Tenotomy
Percutaneous Ultrasonic Tenotomy will be administered via usual protocol within an outpatient surgical setting or in-office procedure. Patient will be anesthetized with local anesthetic and a <5mm incision will be made along the lateral hip with an #11 scalpel. A 14-G angiocath will be introduced through the defective area of the tendon down to the enthesis. Multiple passes will be made and then the percutaneous ultrasonic tenotomy device will be introduced to the defective area. No more than 5 minutes of energy cutting time will be used to address the defective area down to the enthesis, which will debride abnormal tissue but leave normal healthy tissue intact.
干预措施: Percutaneous Ultrasonic Tenotomy (Procedure)
结局指标
主要结局
Change in Numeric Pain Rating Scale
时间窗: Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment
Pain rating scale with a minimum score of 0 (No pain) and a maximum score of 10 (worst pain imaginable).
次要结局
- Change in Victorian Institute for Sport Assessment for Gluteal Tendinopathy Score(Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment)
- Change in Gluteal Muscle Strength(Baseline, 12 weeks post treatment, 48 weeks post treatment)
- Change in Hip Disability and Osteoarthritis Outcome Score(Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment)