TENEX for Trochanteric Bursitis

(RCT GTPS Trial)

Overseen By Asude N. Hasanoglu, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Significant mobility restrictions, pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day (outpatient procedure)

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it aims to reduce medication use by improving pain and mobility.

What is the purpose of this trial?

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.

Research Team

Sayed E. Wahezi, MD

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

This trial is for adults aged 18-90 with Greater Trochanteric Pain Syndrome (GTPS) confirmed by MRI or CT scan, who haven't improved after at least 6 months of standard medical treatment. It's not suitable for those who've had previous surgery on the affected tendons or have significant mobility restrictions like wheelchair users.

Inclusion Criteria

My hip pain is diagnosed as GTPS confirmed by MRI or CT scan.

I can understand and sign consent forms on my own.

My condition hasn't improved after 6 months of standard treatment.

Exclusion Criteria

I use a wheelchair due to significant mobility restrictions.

I have had surgery on my hip or side thigh area before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ultrasound-guided percutaneous tenotomy using the TENEX device

1 day (outpatient procedure)

1 visit (in-person)

Follow-up

Participants are monitored for pain levels and quality of life improvements post-treatment

2 years

Visits at 1 month, 3 months, 6 months, 1 year, and 2 years

Treatment Details

Interventions

• TENEX

Trial Overview The study tests TENEX, a device used in percutaneous tenotomy to partially release certain tendons around the hip under ultrasound guidance. The goal is to see if this minimally invasive procedure can reduce pain and improve functions such as walking and standing in GTPS patients.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

TENEX device will be used

Group II: Control Active Control 1 Intervention

Standard of care

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+