NCT04299802

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Andrews Research & Education Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Gluteal Tendinitis
• Trochanteric Bursitis
• Tendinopathy

Interventions

Type	Name	Description
DRUG	Leukocyte-Rich Platelet-Rich Plasma	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.
PROCEDURE	Percutaneous Ultrasonic Tenotomy	Discussed in Percutaneous Ultrasonic Tenotomy Arm section

Timeline

• Start date: 2020-02-20
• Primary completion: 2020-05-26
• Completion: 2020-05-26
• First posted: 2020-03-09
• Last updated: 2022-08-11