NCT04299802

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2020

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

March 4, 2020

Last Update Submit

August 9, 2022

Conditions

Gluteal TendinitisTrochanteric BursitisTendinopathy

Keywords

Gluteal TendinopathyTrochanteric BursitisPlatelet-Rich PlasmaPercutaneous Ultrasonic TenotomyOrthobiologicsLateral Hip Pain

Outcome Measures

Primary Outcomes (1)

  • Change in Numeric Pain Rating Scale

    Pain rating scale with a minimum score of 0 (No pain) and a maximum score of 10 (worst pain imaginable).

    Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment

Secondary Outcomes (3)

  • Change in Victorian Institute for Sport Assessment for Gluteal Tendinopathy Score

    Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment

  • Change in Hip Disability and Osteoarthritis Outcome Score

    Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment

  • Change in Gluteal Muscle Strength

    Baseline, 12 weeks post treatment, 48 weeks post treatment

Other Outcomes (1)

  • Change in Visual Analog Scale for Procedure Satisfaction

    Baseline, 24 weeks post treatment, 48 weeks post treatment

Study Arms (2)

Leukocyte-Rich Platelet-Rich Plasma (LR-PRP)

ACTIVE COMPARATOR

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.

Drug: Leukocyte-Rich Platelet-Rich Plasma

Percutaneous Ultrasonic Tenotomy

ACTIVE COMPARATOR

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.

Procedure: Percutaneous Ultrasonic Tenotomy

Interventions

Leukocyte-Rich Platelet-Rich PlasmaDRUG

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.

Also known as: LR-PRP, PRP
Leukocyte-Rich Platelet-Rich Plasma (LR-PRP)
Percutaneous Ultrasonic TenotomyPROCEDURE

Discussed in Percutaneous Ultrasonic Tenotomy Arm section

Also known as: TENEX
Percutaneous Ultrasonic Tenotomy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Active workman's compensation case in progress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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: 27663654RESULT

  • 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.

    PMID: 30031963RESULT

  • 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.

    PMID: 27788903RESULT

  • 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.

    PMID: 29293361RESULT

  • 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.

    PMID: 27268111RESULT

  • 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.

    PMID: 27868077RESULT

  • 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.

    PMID: 30433886RESULT

  • Morrey, Bernard F.

    RESULT

  • 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.

    PMID: 25306494RESULT

MeSH Terms

Conditions

Tendinopathy

Interventions

Guanfacine

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsPhenylacetatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • James Andrews, MD

    Andrews Research & Education Foundation

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Unable to blind procedures as they require different types of devices, procedures and settings.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Clinical Trial tracking Platelet-Rich Plasma injection vs. Percutaneous Ultrasonic Tenotomy for up to 1 year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 9, 2020

Study Start

February 20, 2020

Primary Completion

May 26, 2020

Study Completion

May 26, 2020

Last Updated

August 11, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

No HPI will be disclosed to anyone not involved with the study. The data will be published at the completion of the study and will be publicly available for consumption.