Percutaneous Ultrasonic Tenotomy Versus Platelet Rich Plasma for Gluteal Tendinopathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. Randomization: Subjects will be randomly assigned to the single percutaneous ultrasonic tenotomy procedure or single injection of LR-PRP arms in a 1:1 ratio. Enrollment: The providers from the Andrews Institute will enroll subjects into the study. 60 subjects assigned to two randomization arms will be enrolled: a single percutaneous ultrasonic tenotomy procedure arm and a single LR-PRP injection arm. Study Duration: Estimated Subject Enrollment Period: 36 weeks Treatment and Follow-up Period per Subject: 48 weeks Follow-up Schedule: Follow-up visits will occur at 2 weeks, 6 weeks, 12 weeks, 24 weeks and 48 weeks post-procedure. Visits will include physical examinations, patient-reported outcome questionnaires, medication usage, adverse event monitoring and MRIs. Follow-up phone calls will occur at 24 and 48 weeks post-procedure. Phone calls will include patient-reported outcome questionnaires, medication usage, and adverse event monitoring.

Official Title
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A Prospective Randomized Comparison Study on the Effects of Percutaneous Ultrasonic Tenotomy Versus Leukocyte-Rich Platelet Rich Plasma for Refractory Gluteal Tendinopathy

Conditions
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Gluteal Tendinitis, Trochanteric Bursitis, Tendinopathy

Intervention / Treatment
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* Drug: Leukocyte-Rich Platelet-Rich Plasma
* Procedure: Percutaneous Ultrasonic Tenotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Clinical Trial tracking Platelet-Rich Plasma injection vs. Percutaneous Ultrasonic Tenotomy for up to 1 year
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Leukocyte-Rich Platelet-Rich Plasma (LR-PRP)<br>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. | Drug: Leukocyte-Rich Platelet-Rich Plasma<br>* LR-PRP will be a concentration of PRP with the addition of leukocytes. Studies have shown that LR-PRP is more effective in treating tendinopathy than leukocyte-poor platelet-rich plasma.<br>* Other names: PRP;|
| Active Comparator: Percutaneous Ultrasonic Tenotomy<br>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. | Procedure: Percutaneous Ultrasonic Tenotomy<br>* Discussed in Percutaneous Ultrasonic Tenotomy Arm section<br>* Other names: TENEX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Numeric Pain Rating Scale | Pain rating scale with a minimum score of 0 (No pain) and a maximum score of 10 (worst pain imaginable). | Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Victorian Institute for Sport Assessment for Gluteal Tendinopathy Score | Scores range from 0-100. Higher scores indicate less pain and better function. | Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment | 
| Change in Hip Disability and Osteoarthritis Outcome Score | Scores range from 0-100. 0 indicating the worst possible hip symptoms and 100 indicating no hip symptoms. | Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment | 
| Change in Gluteal Muscle Strength | Manual muscle strength will be assessed by an investigator. The scale used will range from 0-5. Lower scores indicate less strength. | Baseline, 12 weeks post treatment, 48 weeks post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gluteal Tendinopathy, Trochanteric Bursitis, Platelet-Rich Plasma, Percutaneous Ultrasonic Tenotomy, Orthobiologics, Lateral Hip Pain