Percutaneous Ultrasonic Tenotomy Versus Platelet Rich Plasma for Gluteal Tendinopathy

August 9, 2022 updated by: Andrews Research & Education Foundation

A Prospective Randomized Comparison Study on the Effects of Percutaneous Ultrasonic Tenotomy Versus Leukocyte-Rich Platelet Rich Plasma for Refractory Gluteal Tendinopathy

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: 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.
Other Names:
  • PRP
  • LR-PRP
Active Comparator: 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.
Procedure: Percutaneous Ultrasonic Tenotomy
Discussed in Percutaneous Ultrasonic Tenotomy Arm section
Other Names:
  • TENEX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Numeric Pain Rating Scale
Time Frame: Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Victorian Institute for Sport Assessment for Gluteal Tendinopathy Score
Time Frame: Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment
Scores range from 0-100. Higher scores indicate less pain and better function.
Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment
Change in Hip Disability and Osteoarthritis Outcome Score
Time Frame: Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment
Scores range from 0-100. 0 indicating the worst possible hip symptoms and 100 indicating no hip symptoms.
Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment
Change in Gluteal Muscle Strength
Time Frame: Baseline, 12 weeks post treatment, 48 weeks post treatment
Manual muscle strength will be assessed by an investigator. The scale used will range from 0-5. Lower scores indicate less strength.
Baseline, 12 weeks post treatment, 48 weeks post treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analog Scale for Procedure Satisfaction
Time Frame: Baseline, 24 weeks post treatment, 48 weeks post treatment
A VAS for satisfaction is a horizontal line of 100-mm long. At the beginning and at the end, there are two descriptors representing extremes of satisfaction (i.e. no satisfaction and extreme satisfaction). The patient will make a vertical mark on the 100-mm line. The measurement in millimetres will be converted to the same number of points ranging from 0 to 100 points.
Baseline, 24 weeks post treatment, 48 weeks post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrews Research & Education Foundation

Investigators

  • Study Chair: James Andrews, MD, Andrews Research & Education Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2020

Primary Completion (Actual)

May 26, 2020

Study Completion (Actual)

May 26, 2020

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 5, 2020

First Posted (Actual)

March 9, 2020

Study Record Updates

Last Update Posted (Actual)

August 11, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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