Boston Children's Hospital
Norwood, Massachusetts, 02062, United States
Location status: Recruiting
Recruiting
NCT Number: NCT07255248
Hoffa's Fat Pad Impingement (HFPI)
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
12 year–18 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Clinical diagnosis of HFPI (defined as pain to palpation over the medial or lateral aspect of the infrapatellar fat pad, and/or positive hoffa test which is performed by exerting direct pressure over the infrapatellar fat pad as the knee is passively moved from flexion to extension; pain is positive hoffa test)
- Age 12-18 years
- Patients who identify as female
- Organized sports participation is defined as any adult-led game or sport in which three or more people play and/or practice together regularly in a league or association or an adult-led individual athletic activity. Non-organized sport is excluded such as free play.
- Xray and non-contrast MRI of the knee must have been completed for the symptomatic knee
- Must have completed physician-prescribed course of physical therapy for 6-8 weeks
Exclusion criteria
- History of patellar dislocation or subluxation, Ehlers-Danlos syndrome, patellar tendinitis/tendinosis, quadriceps tendinitis/tendinosis, medial plica syndrome, osteochondritis dessicans (OCD) of the knee, knee osteoarthritis, prior knee surgery
- Other concurrent knee derangement such as meniscus or ligament tears
- Radiographic evidence of bony abnormalities other than lateral patellar tilt, patella alta/baja, trochlear dysplasia
- MR positive for internal knee joint derangement, synovitis/inflammatory changes/effusion, OCD
- Patients receiving other knee injections during the study time period (i.e., viscosupplementation injection, Toradol injection)
Treatment and study plan
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.
Primary outcomes
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International Knee Documentation Committee (IKDC Score)
Time frame: From enrollment to 8 weeks after enrollment
The IKDC is a patient-reported outcome measure on a 0-100 scale assessing knee function, symptoms, and sports activities, with higher scores indicating better function, and a lower score indicating low function.
Secondary outcomes
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Peds Quality of Life Score (Peds-QL)
Time frame: From enrollment to 8 weeks after enrollment
The Pediatric Quality of Life Inventory (PedsQL) is a brief measure of health-related quality of life in children and young people. Scoring involves transforming a 0-4 Likert scale (0=never, 4=almost always) into a 0-100 scale by reverse scoring and linear transformation, where higher scores indicate better health-related quality of life and a lower score indicating low health-related quality of life (HRQL).
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Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (PISF)
Time frame: From enrollment to 8 weeks after enrollment
The PISF is designed to measure the extent to which pain interferes with a person's: Work or household chores, Social activities, Enjoyment of life, and Physical activities. Each question has five response options ranging in value from one to five. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. A higher score indicates higher pain levels and pain interference, and a lower score indicates lower pain interference.
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Level of Activity per week
Time frame: From enrollment to 8 weeks after enrollment
Patients will report hours of activity per week during the study
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Self-report pain flare post injection
Time frame: 4 weeks post injection
Patients will self-report any pain flares that occur 4 weeks after receiving the injection
Study contacts
Contact information is provided by the study sponsor or research team.
Dai Sugimoto, PhD
CONTACT
Olivia Elie, B.S.
CONTACT
Sponsors and collaborators
Lead sponsor
Boston Children's Hospital
Other
Registry information
Official study title
Hoffa's Fat Pad Impingement (HFPI): Saline Injection Verus Ultrasound Guided Cortisone Injection: A Randomized Trial in Adolescent Female Athletes
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Nov 28, 2025
- Registry last updated
- Mar 23, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.