WithdrawnNot Applicable

Percutaneous Ultrasonic Tenotomy Versus Platelet Rich Plasma for Gluteal Tendinopathy

Stopped: Study not being pursued

0Started 2020-02-20

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Numeric Pain Rating Scale

Timeframe: Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment

Trial details

NCT IDNCT04299802

SponsorAndrews Research & Education Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-26

View on ClinicalTrials.gov More Gluteal Tendinitis trials