The goal of this study is to determine if a newer tenotomy technique utilizing an ultrasound needle is more effective than the traditional tenotomy technique utilizing a simple hypodermic needle for gluteal tendinosis. The main questions it aims to answer are:
1. Is pain from the gluteal tendinosis improved with either technique, and, if so, is there a difference in the improvement between techniques? 2. Is there an improvement in function for gluteal tendinosis, and, if so, is there a difference between techniques?
Diagnosis of gluteal (medius and/or minimus) tendinosis confirmed clinically and with ultrasonography or MRI
Failure to improve after 3 months of nonoperative treatment
Symptoms present for longer than 3 months
Patients with concomitant injuries or pain
Full thickness tears of the affected tendon
Prior corticosteroid injection of the affected tendon within the last 3 months
Prior PNT of the affected tendon
Parallel
Percutaneous needle tenotomy (PNT)
Procedure/SurgeryUtilization of a traditional tenotomy technique (PNT) to treat gluteal tendinosis
Percutaneous ultrasonic tenotomy (PUT, Tenex Device)
DeviceUtilization of ultrasonic tenotomy technique (PUT) to treat gluteal tendinosis
Change from baseline in pain, as measured by the Visual Analog Scale (VAS)
The VAS measures the severity of pain. Scores range from 0 to 100 mm line with 0 representing no pain and 100 representing the worst pain imaginable.
Change from baseline in physical function, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function grading scale for activities of daily living (ADLs)
The PROMIS physical function score is a standardized measure of how a person's physical abilities affect their daily life. It is a T-score with a population average of 50 and a standard deviation of 10 with scores above 50 indicating above-average daily function and below 50 indicating below-average physical function. The range of scores is from 20 to 80.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
