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RecruitingNCT07255248

Hoffa's Fat Pad Impingement (HFPI)

Hoffa's Fat Pad Impingement (HFPI): Saline Injection Verus Ultrasound Guided Cortisone Injection: A Randomized Trial in Adolescent Female Athletes

Status
Recruiting
Phase
Phase 4
Study type
Interventional
Enrollment
62 (estimated)
Sponsor
Boston Children's Hospital · Academic / Other
Sex
Female
Age
12 Years – 18 Years
Healthy volunteers
Not accepted

Summary

The aim of the study is to investigate treatment outcomes for refractory anterior knee pain due to Hoffa's Fat Pad Impingement (HFPI) in young female athletes. Specifically, the study team will study pediatric female athletes with HFPI, and treatment outcomes of US-guided Hoffa's Fat Pad (HFP) corticosteroid injection compared to standard care (physical therapy, bracing, no injection) and saline injection. There will be two arms in this study, 1, a corticosteroid injection and physical therapy and 2, physical therapy and a saline injection. The intent of this study is to measure treatment outcomes, and the research team is not looking at the safety and effectiveness of the lidocaine-methylprednisolone mixture.

Conditions

Interventions

TypeNameDescription
DRUGmethylprednisolone acetate and lidocaineIf you are randomized to the intervention group, you will receive an ultrasound guided corticosteroid injection to the hoffa's fat pad at your visit. Ultrasound guided corticosteroids injections are a common and approved procedure for this condition done at Boston Children's Hospital in the sports medicine clinic. You will be sent patient reported outcomes including quality of life, pain interference, symptoms and function, and level of activity at 4 weeks and 8 weeks following your injection.
DRUGSaline injection (Octreotide LAR placebo)If you are randomized to the control group, you will receive a saline injection to the hoffa's fat pad at your visit. Saline injections are safe for the intended use of being a placebo injection. After your injection, you will be required to continue with physical therapy. You will be sent patient reported outcomes including quality of life, pain interference, symptoms and function, and level of activity at 4 weeks and 8 weeks following your injection.

Timeline

Start date
2026-03-01
Primary completion
2027-11-01
Completion
2028-01-02
First posted
2025-11-28
Last updated
2026-03-23

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07255248. Inclusion in this directory is not an endorsement.