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Not yet recruiting Not applicable NCT07540806

Ultrasound-Guided Percutaneous Needle Tenotomy (PNT) vs Percutaneous Ultrasonic Needle Tenotomy (PUT) for Gluteal Tendinosis

No applicable phase (e.g. observational)
Conditions: Tendinopathy Tendinosis Gluteal Tendinitis

Sponsor: University of Colorado, Denver

trial.available_in: БГ
Overview
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?
Description
Study Design This study is designed as a single-blinded, randomized control trial with two parallel arms comparing PNT vs PUT device for the treatment of gluteal (medius and minimus) tendinosis with analysis of pain, physical function, activities of daily living (ADLs) and overall health over four months. Participants will be randomly assigned (1:1) to receive PNT or PUT at one academic medical center. Each participant will be assigned a patient ID and randomized to one of the two groups. The participants and outcomes assessors will be blinded to treatment group allocation, but the physician administering treatment will not be blinded.
Who can participate
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Significant abnormalities of bony or tendon morphology
Interventions
Percutaneous needle tenotomy (PNT)
PROCEDURE
Percutaneous ultrasonic tenotomy (PUT, Tenex Device)
DEVICE
Locations 1
United States (1)
UCHealth CU Sports Medicine - Colorado Center
Denver , Colorado
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
01.06.2026
Completion date
01.04.2028
Registry ID
NCT07540806
Source
clinicaltrials.gov
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