Percutaneous Ultrasonic Tenotomy Versus Platelet Rich Plasma for Gluteal Tendinopathy
NCT ID: NCT04299802
Last Updated: 2022-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2020-02-20
2020-05-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Leukocyte-Rich Platelet-Rich Plasma (LR-PRP)
LR-PRP will be administered via usual protocol with venous blood draw and concentration via centrifugation. The LR-PRP will be injected under ultrasound guidance into the gluteus minimus and gluteus medius tendons, enthesis and surrounding bursae.
Leukocyte-Rich Platelet-Rich Plasma
LR-PRP will be a concentration of PRP with the addition of leukocytes. Studies have shown that LR-PRP is more effective in treating tendinopathy than leukocyte-poor platelet-rich plasma.
Percutaneous Ultrasonic Tenotomy
Percutaneous Ultrasonic Tenotomy will be administered via usual protocol within an outpatient surgical setting or in-office procedure. Patient will be anesthetized with local anesthetic and a \<5mm incision will be made along the lateral hip with an #11 scalpel. A 14-G angiocath will be introduced through the defective area of the tendon down to the enthesis. Multiple passes will be made and then the percutaneous ultrasonic tenotomy device will be introduced to the defective area. No more than 5 minutes of energy cutting time will be used to address the defective area down to the enthesis, which will debride abnormal tissue but leave normal healthy tissue intact.
Percutaneous Ultrasonic Tenotomy
Discussed in Percutaneous Ultrasonic Tenotomy Arm section
Interventions
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Leukocyte-Rich Platelet-Rich Plasma
LR-PRP will be a concentration of PRP with the addition of leukocytes. Studies have shown that LR-PRP is more effective in treating tendinopathy than leukocyte-poor platelet-rich plasma.
Percutaneous Ultrasonic Tenotomy
Discussed in Percutaneous Ultrasonic Tenotomy Arm section
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Andrews Research & Education Foundation
OTHER
Responsible Party
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Principal Investigators
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James Andrews, MD
Role: STUDY_CHAIR
Andrews Research & Education Foundation
References
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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.
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.
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.
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.
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.
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.
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.
Morrey, Bernard F.
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.
Other Identifiers
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112233
Identifier Type: -
Identifier Source: org_study_id
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