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 — DRUG
    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.
  • Saline injection (Octreotide LAR placebo) — DRUG
    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.

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 Injection
    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.
  • Active Comparator: Intervention Group: Corticosteroid Injection
    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.

Primary Outcome Measure

International Knee Documentation Committee (IKDC Score) [ Time Frame: From enrollment to 8 weeks after enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalNorwoodMassachusetts02062
Julie S Han, MD
614-218-0139

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