Percutaneous Ultrasonic Tenotomy Versus Platelet Rich Plasma for Gluteal Tendinopathy
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| ClinicalTrials.gov Identifier: NCT04299802 |
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Recruitment Status :
Withdrawn
(Study not being pursued)
First Posted : March 9, 2020
Last Update Posted : August 11, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gluteal Tendinitis Trochanteric Bursitis Tendinopathy | Drug: Leukocyte-Rich Platelet-Rich Plasma Procedure: Percutaneous Ultrasonic Tenotomy | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized Clinical Trial tracking Platelet-Rich Plasma injection vs. Percutaneous Ultrasonic Tenotomy for up to 1 year |
| Masking: | None (Open Label) |
| Masking Description: | Unable to blind procedures as they require different types of devices, procedures and settings. |
| Primary Purpose: | Treatment |
| Official Title: | A Prospective Randomized Comparison Study on the Effects of Percutaneous Ultrasonic Tenotomy Versus Leukocyte-Rich Platelet Rich Plasma for Refractory Gluteal Tendinopathy |
| Actual Study Start Date : | February 20, 2020 |
| Actual Primary Completion Date : | May 26, 2020 |
| Actual Study Completion Date : | May 26, 2020 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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:
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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.
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Procedure: Percutaneous Ultrasonic Tenotomy
Discussed in Percutaneous Ultrasonic Tenotomy Arm section
Other Name: TENEX |
- 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).
- 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.
- 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.
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04299802
| Study Chair: | James Andrews, MD | Andrews Research & Education Foundation |
| Responsible Party: | Andrews Research & Education Foundation |
| ClinicalTrials.gov Identifier: | NCT04299802 |
| Other Study ID Numbers: |
112233 |
| First Posted: | March 9, 2020 Key Record Dates |
| Last Update Posted: | August 11, 2022 |
| Last Verified: | August 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Gluteal Tendinopathy Trochanteric Bursitis Platelet-Rich Plasma |
Percutaneous Ultrasonic Tenotomy Orthobiologics Lateral Hip Pain |
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Tendinopathy Bursitis Muscular Diseases Musculoskeletal Diseases |
Tendon Injuries Wounds and Injuries Joint Diseases |