Percutaneous Ultrasonic Tenotomy Versus Platelet Rich Plasma for Gluteal Tendinopathy

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

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.

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.

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