Gluteal TendinitisNCT04299802
Percutaneous Ultrasonic Tenotomy Versus Platelet Rich Plasma for Gluteal Tendinopathy
A study testing Leukocyte-Rich Platelet-Rich Plasma and Percutaneous Ultrasonic Tenotomy in people with Gluteal Tendinitis and Trochanteric Bursitis, run by Andrews Research & Education Foundation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gluteal Tendinitis, Trochanteric Bursitis, Tendinopathy
- What is being tested?
- Leukocyte-Rich Platelet-Rich Plasma and Percutaneous Ultrasonic Tenotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2020to 26 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Gluteal Tendinitis, Trochanteric Bursitis, Tendinopathy
- Being tested
- Leukocyte-Rich Platelet-Rich Plasma, Percutaneous Ultrasonic Tenotomy
- Keywords
- Gluteal Tendinopathy, Trochanteric Bursitis, Platelet-Rich Plasma, Percutaneous Ultrasonic Tenotomy, Orthobiologics, Lateral Hip Pain
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leukocyte-Rich Platelet-Rich PlasmaDrug
Also called LR-PRP, PRP
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 TenotomyProcedure or surgery
Also called TENEX
Discussed in Percutaneous Ultrasonic Tenotomy Arm section
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Percutaneous Ultrasonic Tenotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Scores range from 0-100. Higher scores indicate less pain and better function.
Measured: Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment
Change in Hip Disability and Osteoarthritis Outcome Score
Scores range from 0-100. 0 indicating the worst possible hip symptoms and 100 indicating no hip symptoms.
Measured: Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment
Change in Gluteal Muscle Strength
Manual muscle strength will be assessed by an investigator. The scale used will range from 0-5. Lower scores indicate less strength.
Measured: Baseline, 12 weeks post treatment, 48 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start20 Feb 2020
- Primary completion26 May 2020
- Study completion26 May 2020
Why it stopped: Study not being pursued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Gluteal TendinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial tracking Platelet-Rich Plasma injection vs. Percutaneous Ultrasonic Tenotomy for up to 1 year
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrews Research & Education Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Andrews, MD, Study chair, Andrews Research & Education Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299802
- Sponsor's protocol ID
- 112233
- Status last verified
- Aug 2022
- First submitted
- 4 Mar 2020
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 27663654Borg-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.
PubMed 30031963Wu 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.
PubMed 27788903Fitzpatrick 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.
PubMed 29293361Fitzpatrick 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.
PubMed 27268111Lee 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.
PubMed 27868077Neph 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.
PubMed 30433886Morrey, 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.
PubMed 25306494
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparison Study on the Effects of Percutaneous Ultrasonic Tenotomy Versus Leukocyte-Rich Platelet Rich Plasma for Refractory Gluteal Tendinopathy
- ClinicalTrials.gov ID
- NCT04299802
- Acronym / sponsor ID
- 112233
- Conditions
- Gluteal Tendinitis, Trochanteric Bursitis, Tendinopathy
- Keywords
- Gluteal Tendinopathy, Trochanteric Bursitis, Platelet-Rich Plasma, Percutaneous Ultrasonic Tenotomy, Orthobiologics, Lateral Hip Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not being pursued
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Andrews Research & Education FoundationUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 26 May 2020 (actual)
- Study completion
- 26 May 2020 (actual)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial tracking Platelet-Rich Plasma injection vs. Percutaneous Ultrasonic Tenotomy for up to 1 year
| Arm | Type | Receives |
|---|---|---|
| Leukocyte-Rich Platelet-Rich Plasma (LR-PRP) | Active comparator | Drug: Leukocyte-Rich Platelet-Rich PlasmaLR-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. |
| Percutaneous Ultrasonic Tenotomy | Active comparator | Procedure: Percutaneous Ultrasonic TenotomyPercutaneous 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leukocyte-Rich Platelet-Rich PlasmaAlso: LR-PRP, PRPLR-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. | Drug | Leukocyte-Rich Platelet-Rich Plasma (LR-PRP) |
| Percutaneous Ultrasonic TenotomyAlso: TENEXDiscussed in Percutaneous Ultrasonic Tenotomy Arm section | Procedure or surgery | Percutaneous Ultrasonic Tenotomy |
Primary outcome
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).
3 secondary outcomes
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
Change in Hip Disability and Osteoarthritis Outcome Score
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Results publication: PubMed 27663654Jacobson 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.
- Results publication: PubMed 30031963Borg-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.
- Results publication: PubMed 27788903Wu 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.
- Results publication: PubMed 29293361Fitzpatrick 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.
- Results publication: PubMed 27268111Fitzpatrick 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.
- Results publication: PubMed 27868077Lee 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.
- Results publication: PubMed 30433886Neph 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.
- Results publicationMorrey, Bernard F.
- Results publication: PubMed 25306494Barnes 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Andrews, MD study chair
Andrews Research & Education Foundation
Questions about this trial
What is this clinical trial studying?
A study testing Leukocyte-Rich Platelet-Rich Plasma and Percutaneous Ultrasonic Tenotomy in people with Gluteal Tendinitis and Trochanteric Bursitis, run by Andrews Research & Education Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numeric Pain Rating Scale (time frame: Baseline, 12 weeks post treatment, 48 weeks post treatment, 1 year post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04299802, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.