Status:
WITHDRAWN
Percutaneous Ultrasonic Tenotomy Versus Platelet Rich Plasma for Gluteal Tendinopathy
Lead Sponsor:
Andrews Research & Education Foundation
Conditions:
Gluteal Tendinitis
Trochanteric Bursitis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 wil...
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-PR...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04299802
Start Date
February 20 2020
End Date
May 26 2020
Last Update
August 11 2022
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