An interventional study of Leukocyte-Rich Platelet-Rich Plasma and Percutaneous Ultrasonic Tenotomy in Gluteal Tendinitis, Trochanteric Bursitis and Tendinopathy, sponsored by Andrews Research & Education Foundation. Withdrawn. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-08-11.
Sponsored by Andrews Research & Education Foundation · Not applicable, Interventional, and Treatment
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.
415 studies on the registry are indexed under Tendinopathy; 63 are open to participants now.
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Exclusion Criteria:
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
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
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.
Also known as: LR-PRP, PRP
Discussed in Percutaneous Ultrasonic Tenotomy Arm section
Also known as: TENEX
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).
Time frame: Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment
Change in Victorian Institute for Sport Assessment for Gluteal Tendinopathy Score
Scores range from 0-100. Higher scores indicate less pain and better function.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 12 weeks post treatment, 48 weeks post treatment
Change in Visual Analog Scale for Procedure Satisfaction
A VAS for satisfaction is a horizontal line of 100-mm long. At the beginning and at the end, there are two descriptors representing extremes of satisfaction (i.e. no satisfaction and extreme satisfaction). The patient will make a vertical mark on the 100-mm line. The measurement in millimetres will be converted to the same number of points ranging from 0 to 100 points.
Time frame: Baseline, 24 weeks post treatment, 48 weeks post treatment
No study locations are listed for this record.
Plan to share: No — No HPI will be disclosed to anyone not involved with the study. The data will be published at the completion of the study and will be publicly available for consumption.
Ran from Feb 2020 to primary completion in May 2020, 3 months.
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This study is withdrawn, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Platelet rich plasma
Andrews Research & Education Foundation