Hoffa's Fat Pad Impingement (HFPI)
Part of paid clinical trials in Norwood, Massachusetts.
- Sponsor
- Boston Children's Hospital
- Study ID
- NCT07255248
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Hoffa's Fat Pad Impingement
Eligibility Criteria
- Sex
- FEMALE
- Age
- 12 Years - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- methylprednisolone acetate and lidocaine — DRUGIf 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.
- Saline injection (Octreotide LAR placebo) — DRUGIf 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.
Study Details
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.
Key Dates
- Start date
- Mar 1, 2026
- Status verified
- Mar 2026
- Primary completion
- Nov 1, 2027
- Completion
- Jan 2, 2028
Study Design
- Enrollment
- 62 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: Control Group: Saline InjectionIf 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.
- Active Comparator: Intervention Group: Corticosteroid InjectionIf 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.
Primary Outcome Measure
International Knee Documentation Committee (IKDC Score) [ Time Frame: From enrollment to 8 weeks after enrollment ]
Central Contacts
- Olivia Elie, B.S.781-953-1086
- Dai Sugimoto, PhD
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Boston Children's Hospital | Norwood | Massachusetts | 02062 |