Clinical trial NCT04299802: Percutaneous Ultrasonic Tenotomy Versus Platelet Rich Plasma for Gluteal Tendinopathy
Official title: A Prospective Randomized Comparison Study on the Effects of Percutaneous Ultrasonic Tenotomy Versus Leukocyte-Rich Platelet Rich Plasma for Refractory Gluteal Tendinopathy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gluteal Tendinitis
Trochanteric Bursitis
Tendinopathy
Keywords: Gluteal Tendinopathy
Trochanteric Bursitis
Platelet-Rich Plasma
Percutaneous Ultrasonic Tenotomy
Orthobiologics
Lateral Hip Pain
Lead sponsor: Andrews Research & Education Foundation
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial tracking Platelet-Rich Plasma injection vs. Percutaneous Ultrasonic Tenotomy for up to 1 year
Primary purpose: TREATMENT

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 will be demonstrated in a superiority trial design by comparing improvement in pain and function after a single percutaneous ultrasonic tenotomy versus a single injection of LR-PRP in refractory gluteal tendinopathy that has failed conservative management. The investigators hypothesize that both procedures will show improvement to pain and function from baseline to 24 weeks and improvement will remain at 48 weeks follow-up. The investigators propose to test this hypothesis with a series of randomized cases of gluteal tendinopathy treated with one of the proposed treatment arms and evaluate at specified intervals with validated clinical outcome measures.

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-PRP) in subjects with symptomatic gluteal tendinopathy which has been refractory to conservative treatment

Hypothesis of the Study:

The hypothesis of this study is that subjects with symptomatic gluteal tendinopathy (defined as \<50% partial-thickness tear of either the gluteus medius or gluteus minimus tendons on MRI or US) who receive either a single percutaneous ultrasonic tenotomy or a single injection of LR-PRP will demonstrate less pain and improved hip function compared to pre-treatment baseline.

Primary Objective:

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 will be demonstrated in a superiority trial design by comparing improvement in pain and function after a single percutaneous ultrasonic tenotomy versus a single injection of LR-PRP in refractory gluteal tendinopathy that has failed conservative management.

Randomization:

Subjects will be randomly assigned to the single percutaneous ultrasonic tenotomy procedure or single injection of LR-PRP arms in a 1:1 ratio.

Enrollment:

The providers from the Andrews Institute will enroll subjects into the study. 60 subjects assigned to two randomization arms will be enrolled: a single percutaneous ultrasonic tenotomy procedure arm and a single LR-PRP injection arm.

Study Duration:

Estimated Subject Enrollment Period: 36 weeks Treatment and Follow-up Period per Subject: 48 weeks

Follow-up Schedule:

Follow-up visits will occur at 2 weeks, 6 weeks, 12 weeks, 24 weeks and 48 weeks post-procedure. Visits will include physical examinations, patient-reported outcome questionnaires, medication usage, adverse event monitoring and MRIs. Follow-up phone calls will occur at 24 and 48 weeks post-procedure. Phone calls will include patient-reported outcome questionnaires, medication usage, and adverse event monitoring.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in Numeric Pain Rating Scale
timeFrame: Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment
Secondary outcomes:
measure: Change in Victorian Institute for Sport Assessment for Gluteal Tendinopathy Score
timeFrame: Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment
measure: Change in Hip Disability and Osteoarthritis Outcome Score
timeFrame: Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment
measure: Change in Gluteal Muscle Strength
timeFrame: Baseline, 12 weeks post treatment, 48 weeks post treatment
Other outcomes:
measure: Change in Visual Analog Scale for Procedure Satisfaction
timeFrame: Baseline, 24 weeks post treatment, 48 weeks post treatment
Locations:
Study officials:
affiliation: Andrews Research & Education Foundation
name: James Andrews, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: Borg-Stein J, Osoria HL, Hayano T. Regenerative Sports Medicine: Past, Present, and Future (Adapted From the PASSOR Legacy Award Presentation; AAPMR; October 2016). PM R. 2018 Oct;10(10):1083-1105. doi: 10.1016/j.pmrj.2018.07.003. Epub 2018 Jul 19.
citation: Wu PI, Diaz R, Borg-Stein J. Platelet-Rich Plasma. Phys Med Rehabil Clin N Am. 2016 Nov;27(4):825-853. doi: 10.1016/j.pmr.2016.06.002.
citation: Fitzpatrick J, Bulsara MK, O'Donnell J, McCrory PR, Zheng MH. The Effectiveness of Platelet-Rich Plasma Injections in Gluteal Tendinopathy: A Randomized, Double-Blind Controlled Trial Comparing a Single Platelet-Rich Plasma Injection With a Single Corticosteroid Injection. Am J Sports Med. 2018 Mar;46(4):933-939. doi: 10.1177/0363546517745525. Epub 2018 Jan 2.
citation: Fitzpatrick J, Bulsara M, Zheng MH. The Effectiveness of Platelet-Rich Plasma in the Treatment of Tendinopathy: A Meta-analysis of Randomized Controlled Clinical Trials. Am J Sports Med. 2017 Jan;45(1):226-233. doi: 10.1177/0363546516643716. Epub 2016 Jul 21.
citation: Lee JJ, Harrison JR, Boachie-Adjei K, Vargas E, Moley PJ. Platelet-Rich Plasma Injections With Needle Tenotomy for Gluteus Medius Tendinopathy: A Registry Study With Prospective Follow-up. Orthop J Sports Med. 2016 Nov 9;4(11):2325967116671692. doi: 10.1177/2325967116671692. eCollection 2016 Nov.
citation: Neph A, Onishi K, Wang JH. Myths and Facts of In-Office Regenerative Procedures for Tendinopathy. Am J Phys Med Rehabil. 2019 Jun;98(6):500-511. doi: 10.1097/PHM.0000000000001097.
citation: Morrey, Bernard F.
citation: Barnes DE, Beckley JM, Smith J. Percutaneous ultrasonic tenotomy for chronic elbow tendinosis: a prospective study. J Shoulder Elbow Surg. 2015 Jan;24(1):67-73. doi: 10.1016/j.jse.2014.07.017. Epub 2014 Oct 8.