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

Part of paid clinical trials in Denver, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07540806
Status
Not Yet Recruiting

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Conditions

  • Gluteal Tendinitis
  • Tendinopathy
  • Tendinosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Percutaneous needle tenotomy (PNT) — PROCEDURE
    Utilization of a traditional tenotomy technique (PNT) to treat gluteal tendinosis
  • Percutaneous ultrasonic tenotomy (PUT, Tenex Device) — DEVICE
    Utilization of ultrasonic tenotomy technique (PUT) to treat gluteal tendinosis

Study Details

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?

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Dec 1, 2027
Completion
Apr 1, 2028

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Percutaneous needle tenotomy (PNT)
    Traditional tenotomy technique utilizing a hypodermic needle.
  • Active Comparator: Percutaneous ultrasonic tenotomy (PUT, Tenex device)
    Tenotomy utilizing a mechanized ultrasonic device to perform the procedure (Tenex)

Primary Outcome Measure

Change from baseline in pain, as measured by the Visual Analog Scale (VAS) [ Time Frame: Baseline and 2 weeks, 6 weeks, 3 months, and 4 months post-procedure. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCHealth CU Sports Medicine - Colorado CenterDenverColorado80222-

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UCHealth CU Sports Medicine - Colorado Center· Denver, CO

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