Trials / Recruiting
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
| Type | Name | Description |
|---|---|---|
| DRUG | methylprednisolone acetate and lidocaine | If 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. |
| DRUG | Saline 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
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07255248. Inclusion in this directory is not an endorsement.