Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS)

Study Purpose

The aim of this study is to characterize the efficacy of percutaneous tenotomy (PUT) using TENEX®, a device used for the treatment of various tendinopathies. In this study an ultrasound (US) is performed to guide the partial release of gluteus medius and minimus and Iliotibial band tendons in patients diagnosed with refractory Greater Trochanteric Pain Syndrome (GTPS) vs.#46;control. The study team hypothesizes that PUT can improve the pain level and function for individuals suffering with GTPS. The study will assess walking, standing, and side-lying tolerance, as well as medication utilization. The investigator team predicts that this percutaneous outpatient procedure can decrease pain and medication utilization while increasing mobility.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 90 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Aged 18-90.

- People with GTPS of all different levels and etiologies confirmed with MRI or CT scan.

- Ability to give informed consent forms independently.

- Failed conservative medical treatment for at least 6 months.

Exclusion Criteria:

- Significant mobility restrictions; people using wheelchairs.

- Previous surgery to the GMed or ITB

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05710627
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Montefiore Medical Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sayed E. Wahezi, MD
Principal Investigator Affiliation	Montefiore Medical Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Greater Trochanteric Pain Syndrome

Additional Details

Greater trochanteric pain syndrome (GTPS) is one of the most common causes of lateral hip pain in adults. GTPS is repetitive overload tendinopathy of the gluteus medius (GMed) and Iliotibial band (ITB), which play a primary role in hip abduction and pelvic stabilization in walking, stair climbing, running and standing on one leg. It is thought that the core pathology is greater trochanteric bursitis (TB) with or without coexisting gluteal tendinopathy. Some common etiologies include prolonged excessive pressure to the area, injury to the side of the hip, and repetitive movements; however, local steroid injections to the greater TB are not often successful over the long-term. The best estimates of prevalence are from a large, community-based study with over 3000 adults aged 50 to 70 years, in which unilateral GTPS was present in 15 percent of women and 6.6 percent of men. Patients who have not improved after at least 12 months of conservative medical management (CMM), including physical therapy, oral medications, or a local steroid injection have no other conservative treatment recourse. Open surgery for GMed or ITB tears is not recommended unless a tear is diagnosed on MRI. Based on a published study, a 60% improvement was shown in pain with the performance of TENEX of the GMed. The purpose of this project is to study the outcome of GMed and ITB PUT on CMM refractory GTPS. We want to quantify and show the scales of the pain in pre-operative and post-treatment cases. We also want to see how effective the surgery is in specific terms of pain levels because GTPS is a pain syndrome and reduction in pain level is the most important clinical factor. Patient Reported Outcome Measure (PROM) is one of the main outcomes that medical research is validated with and through this study we want to show the most important outcome of GTPS i.e., pain level (PROM for GTPS). Previous studies which focused on surgical outcomes have been mostly single-center trials. Pain and mobility impact patients' Quality of Life (QoL) and medical cost burden due to unemployment, psychosocial well-being, and functional dependence. The standard of care offered to address the pain and mobility needs of those with GTPS is to provide CMM, followed by open or arthroscopic surgery if surgery is indicated. However, there is a treatment gap for those patients who have failed CMM and are not surgical candidates. The authors submit that TENEX of the GMed and ITB may address this gap. The results from this research may have broad impacts on the treatment algorithm for patients with GTPS.

Arms & Interventions

Arms

No Intervention: Control

Standard of care

Experimental: Treatment

TENEX device will be used

Interventions

Device: - TENEX

Use of TENEX device for sectioning of the gluteus medius and ITB tendons.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Montefiore Medical Center, Bronx, New York

Status

Address

Montefiore Medical Center

Bronx, New York, 10461

Site Contact

Asude N. Hasanoglu, MD

[email protected]

929-377-8185

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