Hoffa's Fat Pad Impingement (HFPI)

NCTNCT07255248Other idIRB-P00051842

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 4
Enrollment: 62 participants (estimated)
Sponsor: Boston Children's Hospital · Other
Design: Randomized · Single masking
Countries: 1 country
United States
Start: 1 Mar 2026
Primary completion: 1 Nov 2027 (estimated)
Completion: 2 Jan 2028 (estimated)
First posted: 28 Nov 2025
Last update posted: 23 Mar 2026
Conditions: Hoffa's Fat Pad Impingement

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2026202720282029

Ph 4
Hoffa's Fat Pad Impingement (HFPI)
NCT07255248
1 Mar 2026 to est. 2 Jan 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

methylprednisolone acetate and lidocaineDrug
Saline injection (Octreotide LAR placebo)Drug

Arms2

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 outcomes1

Outcomes the sponsor listed as primary.

International Knee Documentation Committee (IKDC Score)
Time frame · From enrollment to 8 weeks after enrollment
Registry description
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(4)

Peds Quality of Life Score (Peds-QL)
Time frame · From enrollment to 8 weeks after enrollment
Registry description
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).
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (PISF)
Time frame · From enrollment to 8 weeks after enrollment
Registry description
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.
Level of Activity per week
Time frame · From enrollment to 8 weeks after enrollment
Registry description
Patients will report hours of activity per week during the study
Self-report pain flare post injection
Time frame · 4 weeks post injection
Registry description
Patients will self-report any pain flares that occur 4 weeks after receiving the injection

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 12 Years up to 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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)

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