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

NCT07540806 | Not Yet Recruiting FDA Device

• 1 other identifier: 25-1380
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Is pain from the gluteal tendinosis improved with either technique, and, if so, is there a difference in the improvement between techniques?
2. 2.Is there an improvement in function for gluteal tendinosis, and, if so, is there a difference between techniques?

Conditions

Tendinopathy; Tendinosis; Gluteal Tendinitis

Keywords

Tendinopathy; Tendinosis; Gluteal tendinosis; Tenotomy; Percutaneous needle tenotomy; Percutaneous ultrasonic tenotomy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 2 weeks, 6 weeks, 3 months, and 4 months post-procedure.

Secondary Outcomes (1)

• 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)

  Baseline and 2 weeks, 6 weeks, 3 months, and 4 months post-procedure.

Study Arms (2)

Percutaneous needle tenotomy (PNT)

ACTIVE COMPARATOR

Traditional tenotomy technique utilizing a hypodermic needle.

Procedure: Percutaneous needle tenotomy (PNT)

Percutaneous ultrasonic tenotomy (PUT, Tenex device)

ACTIVE COMPARATOR

Tenotomy utilizing a mechanized ultrasonic device to perform the procedure (Tenex)

Device: Percutaneous ultrasonic tenotomy (PUT, Tenex Device)

Interventions

Percutaneous needle tenotomy (PNT) PROCEDURE

Utilization of a traditional tenotomy technique (PNT) to treat gluteal tendinosis

Percutaneous needle tenotomy (PNT)

Percutaneous ultrasonic tenotomy (PUT, Tenex Device) DEVICE

Utilization of ultrasonic tenotomy technique (PUT) to treat gluteal tendinosis

Percutaneous ultrasonic tenotomy (PUT, Tenex device)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

UCHealth CU Sports Medicine - Colorado Center

Denver, Colorado, 80222, United States

Location

Related Publications (17)

• Yelin E, Weinstein S, King T. The burden of musculoskeletal diseases in the United States. Semin Arthritis Rheum. 2016 Dec;46(3):259-260. doi: 10.1016/j.semarthrit.2016.07.013. Epub 2016 Jul 26. No abstract available.

  PMID: 27519477 BACKGROUND

• Millar NL, Silbernagel KG, Thorborg K, Kirwan PD, Galatz LM, Abrams GD, Murrell GAC, McInnes IB, Rodeo SA. Tendinopathy. Nat Rev Dis Primers. 2021 Jan 7;7(1):1. doi: 10.1038/s41572-020-00234-1.

  PMID: 33414454 BACKGROUND

• Hurley ET, Mojica ES, Kanakamedala AC, Meislin RJ, Strauss EJ, Campbell KA, Alaia MJ. Quadriceps tendon has a lower re-rupture rate than hamstring tendon autograft for anterior cruciate ligament reconstruction - A meta-analysis. J ISAKOS. 2022 Apr;7(2):87-93. doi: 10.1016/j.jisako.2021.10.001. Epub 2021 Nov 17.

  PMID: 35543668 BACKGROUND

• Zhou Y, Wang JH. PRP Treatment Efficacy for Tendinopathy: A Review of Basic Science Studies. Biomed Res Int. 2016;2016:9103792. doi: 10.1155/2016/9103792. Epub 2016 Aug 16.

  PMID: 27610386 BACKGROUND

• Smallcomb M, Khandare S, Vidt ME, Simon JC. Therapeutic Ultrasound and Shockwave Therapy for Tendinopathy: A Narrative Review. Am J Phys Med Rehabil. 2022 Aug 1;101(8):801-807. doi: 10.1097/PHM.0000000000001894. Epub 2021 Oct 4.

  PMID: 35859290 BACKGROUND

• Shomal Zadeh F, Shafiei M, Hosseini N, Alipour E, Cheung H, Chalian M. The effectiveness of percutaneous ultrasound-guided needle tenotomy compared to alternative treatments for chronic tendinopathy: a systematic review. Skeletal Radiol. 2023 May;52(5):875-888. doi: 10.1007/s00256-022-04140-3. Epub 2022 Jul 28.

  PMID: 35896736 BACKGROUND

• Finnoff JT, Fowler SP, Lai JK, Santrach PJ, Willis EA, Sayeed YA, Smith J. Treatment of chronic tendinopathy with ultrasound-guided needle tenotomy and platelet-rich plasma injection. PM R. 2011 Oct;3(10):900-11. doi: 10.1016/j.pmrj.2011.05.015. Epub 2011 Aug 26.

  PMID: 21872551 BACKGROUND

• McShane JM, Shah VN, Nazarian LN. Sonographically guided percutaneous needle tenotomy for treatment of common extensor tendinosis in the elbow: is a corticosteroid necessary? J Ultrasound Med. 2008 Aug;27(8):1137-44. doi: 10.7863/jum.2008.27.8.1137.

  PMID: 18645071 BACKGROUND

• Lakhey S, Mansfield M, Pradhan RL, Rijal KP, Paney BP, Manandhar RR. Percutaneous extensor tenotomy for chronic tennis elbow using an 18G needle. Kathmandu Univ Med J (KUMJ). 2007 Oct-Dec;5(4):446-8.

  PMID: 18604073 BACKGROUND

• Bradberry DM, Sussman WI, Mautner KR. Ultrasound-Guided Percutaneous Needle Tenotomy for Chronic Tensor Fascia Lata Tendinopathy: A Case Series and Description of Sonographic Findings. PM R. 2018 Sep;10(9):979-983. doi: 10.1016/j.pmrj.2018.01.009. Epub 2018 Feb 8.

  PMID: 29428875 BACKGROUND

• Maag L, Linder S, Hackett L, Mitchkash M, Farley T, Lamar D, Fisher N, Burnham B. Effectiveness of Percutaneous Needle Tenotomy for Tendinopathies: A Systematic Review. Sports Health. 2025 Jul;17(4):834-842. doi: 10.1177/19417381241275659. Epub 2024 Sep 5.

  PMID: 39238190 BACKGROUND

• Wahezi SE, Patel A, Yerra S, Naeimi T, Sayed D, Oakes D, Ortiz N, Yee M, Yih C, Sitapara K, Schulz J, Kohan L, Rosenburg J, Schwechter E, Chan F, Gonzalez D, Baker C. Percutaneous Ultrasound-Guided Tenotomy of the Iliotibial Band for Trochanteric Pain Syndrome: A Longitudinal Observational Study With One-Year Durability Results. Pain Physician. 2023 Jul;26(4):393-401.

  PMID: 37535779 BACKGROUND

• Jacobson JA, Yablon CM, Henning PT, Kazmers IS, Urquhart A, Hallstrom B, Bedi A, Parameswaran A. Greater Trochanteric Pain Syndrome: Percutaneous Tendon Fenestration Versus Platelet-Rich Plasma Injection for Treatment of Gluteal Tendinosis. J Ultrasound Med. 2016 Nov;35(11):2413-2420. doi: 10.7863/ultra.15.11046. Epub 2016 Sep 23.

  PMID: 27663654 BACKGROUND

• Kirschner JS, Cheng J, Hurwitz N, Santiago K, Lin E, Beatty N, Kingsbury D, Wendel I, Milani C. Ultrasound-guided percutaneous needle tenotomy (PNT) alone versus PNT plus platelet-rich plasma injection for the treatment of chronic tendinosis: A randomized controlled trial. PM R. 2021 Dec;13(12):1340-1349. doi: 10.1002/pmrj.12583. Epub 2021 Apr 28.

  PMID: 33644963 BACKGROUND

• Baker CL Jr, Mahoney JR. Ultrasound-Guided Percutaneous Tenotomy for Gluteal Tendinopathy. Orthop J Sports Med. 2020 Mar 19;8(3):2325967120907868. doi: 10.1177/2325967120907868. eCollection 2020 Mar.

  PMID: 32232066 BACKGROUND

• Gaspar MP, Motto MA, Lewis S, Jacoby SM, Culp RW, Lee Osterman A, Kane PM. Platelet-Rich Plasma Injection With Percutaneous Needling for Recalcitrant Lateral Epicondylitis: Comparison of Tenotomy and Fenestration Techniques. Orthop J Sports Med. 2017 Dec 6;5(12):2325967117742077. doi: 10.1177/2325967117742077. eCollection 2017 Dec.

  PMID: 29238734 BACKGROUND

• Carlier Y, Bonichon F, Peuchant A. Recalcitrant lateral epicondylitis: Early results with a new technique combining ultrasonographic percutaneous tenotomy with platelet-rich plasma injection. Orthop Traumatol Surg Res. 2021 Apr;107(2):102604. doi: 10.1016/j.otsr.2020.03.016. Epub 2021 Jan 6.

  PMID: 33358122 BACKGROUND

Related Links

• White Paper on the tenotomy device, TendoNova Ocelot

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Study Officials

• Kyle V Goerl, MD

  University of Colorado Denver, Anschutz Medical Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyle V Goerl, MD

CONTACT

3037249700; kyle.goerl@cuanschutz.edu

David Vargas

CONTACT

juan.2.vargas@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)