Recruiting

Corticosteroid InjectionHoffa's Fat Pad Impingement (HFPI)

Sponsor:

Boston Children's Hospital

Code:

NCT07255248

Conditions

Hoffa's Fat Pad Impingement

Eligibility Criteria

Sex: Female

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

methylprednisolone acetate and lidocaine

Saline injection (Octreotide LAR placebo)

Study Details

Brief 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

Hoffa's Fat Pad Impingement

Study ID

NCT07255248

Start date

Mar 1, 2026

Status verified date

Mar, 2026

Completion date

Jan 2, 2028

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 12 - 18

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

62 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

methylprednisolone acetate and lidocaine

Saline injection (Octreotide LAR placebo)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Olivia Elie, B.S.

781-953-1086 olivia.elie@childrens.harvard.edu

Dai Sugimoto, PhD

dai.sugimoto@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Norwood, Massachusetts, United States, 02062

Contacts

Julie S Han, MD

614-218-0139 julie.han@childrens.harvard.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-03-23.