Evaluation of Percutaneous Tenotomy of the Gluteus Medius and Iliotibial Band for Greater Trochanteric Pain Syndrome (GTPS): A Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of this study is to evaluate how an ultrasound-guided percutaneous procedure, TENEX, can help people with chronic hip pain resulting from a condition called Greater Trochanteric Pain Syndrome (GTPS) and 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 control. The investigator team hypothesizes that the new TENEX can improve the pain level for individuals with GTPS to help those individuals perform their activities of daily living (ADLs), e.g., walking, standing, and side-lying, as well as demonstrate less medication utilization. The study predicts that this percutaneous outpatient procedure can decrease pain, increase mobility, and decrease medication utilization. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Montefiore Medical Center
RECRUITING
The Bronx
Contact Information
Primary
Tahereh Naeimi, MD
tnaeimi@montefiore.org
3479778678
Time Frame
Start Date: 2025-03-11
Estimated Completion Date: 2027-03
Participants
Target number of participants: 150
Treatments
No_intervention: Control
Standard of care
Experimental: Treatment
TENEX device will be used
Related Therapeutic Areas
Sponsors
Leads: Montefiore Medical Center

This content was sourced from clinicaltrials.gov