Hoffa's Fat Pad Impingement (HFPI)

NCT07255248 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB-P00051842
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• International Knee Documentation Committee (IKDC Score)

  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.

  From enrollment to 8 weeks after enrollment

Secondary Outcomes (4)

• Peds Quality of Life Score (Peds-QL)

  From enrollment to 8 weeks after enrollment

• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (PISF)

  From enrollment to 8 weeks after enrollment

• Level of Activity per week

  From enrollment to 8 weeks after enrollment

• Self-report pain flare post injection

  4 weeks post injection

Study Arms (2)

Control Group: Saline Injection

PLACEBO COMPARATOR

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.

Drug: Saline injection (Octreotide LAR placebo)

Intervention Group: Corticosteroid Injection

ACTIVE COMPARATOR

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.

Drug: methylprednisolone acetate and lidocaine

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.

Intervention Group: Corticosteroid 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.

Control Group: Saline Injection

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Norwood, Massachusetts, 02062, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 39527393 BACKGROUND

• 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.

  PMID: 17981168 BACKGROUND

• 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.

  PMID: 27811513 BACKGROUND

• 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.

  PMID: 11810167 BACKGROUND

• 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.

  PMID: 21098197 BACKGROUND

• 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.

  PMID: 38365902 BACKGROUND

• 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.

  PMID: 35512891 BACKGROUND

• 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.

  PMID: 27068617 BACKGROUND

• 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.

  PMID: 22149697 BACKGROUND

• 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.

  PMID: 37296488 BACKGROUND

MeSH Terms

Interventions

Methylprednisolone Acetate; Lidocaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Julie Han, M.D.

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivia Elie, B.S.

CONTACT

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

Dai Sugimoto, PhD

CONTACT

dai.sugimoto@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: November 28, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): January 2, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: IPD will be analyzed for the manuscript, and all will be de-identified. This is approximately from the end of the study collection December 2027 to June 2028 for analysis.

Locations

US (1)