Hoffa's Fat Pad Impingement (HFPI)

NCT ID: NCT07255248

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-01-02

Brief Summary

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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.

Detailed Description

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Conditions

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Hoffa's Fat Pad Impingement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

methylprednisolone acetate and lidocaine

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Saline injection (Octreotide LAR placebo)

Intervention Type 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.

Interventions

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methylprednisolone acetate and lidocaine

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.

Intervention Type DRUG

Saline injection (Octreotide LAR placebo)

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.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Julie Han

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie Han, M.D.

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Central Contacts

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Olivia Elie, B.S.

Role: CONTACT

781-953-1086

Dai Sugimoto, PhD

Role: CONTACT

References

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Abelleyra Lastoria DA, Benny CK, Hing CB. Predisposing factors for Hoffa's fat pad syndrome: a systematic review. Knee Surg Relat Res. 2023 Jun 9;35(1):17. doi: 10.1186/s43019-023-00192-4.

Reference Type BACKGROUND
PMID: 37296488 (View on PubMed)

Katz NB, Tsitsilianos N, Nowak AS, Douglas SR, Tenforde AS, Borg-Stein J. Advanced Non-Operative Interventions for Anterior Knee Pain. Curr Rev Musculoskelet Med. 2024 Dec;17(12):589-615. doi: 10.1007/s12178-024-09930-x. Epub 2024 Nov 11.

Reference Type BACKGROUND
PMID: 39527393 (View on PubMed)

House CV, Connell DA. Therapeutic ablation of the infrapatellar fat pad under ultrasound guidance: a pilot study. Clin Radiol. 2007 Dec;62(12):1198-201. doi: 10.1016/j.crad.2007.07.005. Epub 2007 Sep 14.

Reference Type BACKGROUND
PMID: 17981168 (View on PubMed)

Bessette M, Saluan P. Patellofemoral Pain and Instability in Adolescent Athletes. Sports Med Arthrosc Rev. 2016 Dec;24(4):144-149. doi: 10.1097/JSA.0000000000000133.

Reference Type BACKGROUND
PMID: 27811513 (View on PubMed)

Chung CB, Skaf A, Roger B, Campos J, Stump X, Resnick D. Patellar tendon-lateral femoral condyle friction syndrome: MR imaging in 42 patients. Skeletal Radiol. 2001 Dec;30(12):694-7. doi: 10.1007/s002560100409. Epub 2001 Sep 7.

Reference Type BACKGROUND
PMID: 11810167 (View on PubMed)

Subhawong TK, Eng J, Carrino JA, Chhabra A. Superolateral Hoffa's fat pad edema: association with patellofemoral maltracking and impingement. AJR Am J Roentgenol. 2010 Dec;195(6):1367-73. doi: 10.2214/AJR.10.4668.

Reference Type BACKGROUND
PMID: 21098197 (View on PubMed)

Feuerriegel GC, Marth AA, Frohlich S, Scherr J, Sporri J, Sutter R. Superolateral Hoffa fat pad edema in adolescent competitive alpine skiers: temporal evolution over 4 years and risk factors. Insights Imaging. 2024 Feb 16;15(1):52. doi: 10.1186/s13244-024-01633-8.

Reference Type BACKGROUND
PMID: 38365902 (View on PubMed)

Mills MK, Allen H. Knee Plical Pathology and Impingement Syndromes. Magn Reson Imaging Clin N Am. 2022 May;30(2):293-305. doi: 10.1016/j.mric.2021.11.008. Epub 2022 Apr 13.

Reference Type BACKGROUND
PMID: 35512891 (View on PubMed)

Eymard F, Chevalier X. Inflammation of the infrapatellar fat pad. Joint Bone Spine. 2016 Jul;83(4):389-93. doi: 10.1016/j.jbspin.2016.02.016. Epub 2016 Apr 7.

Reference Type BACKGROUND
PMID: 27068617 (View on PubMed)

Dragoo JL, Johnson C, McConnell J. Evaluation and treatment of disorders of the infrapatellar fat pad. Sports Med. 2012 Jan 1;42(1):51-67. doi: 10.2165/11595680-000000000-00000.

Reference Type BACKGROUND
PMID: 22149697 (View on PubMed)

Other Identifiers

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IRB-P00051842

Identifier Type: -

Identifier Source: org_study_id

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