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NCT07255248·Phase 4·INTERVENTIONAL

Hoffa's Fat Pad Impingement (HFPI)

OctreotideOtherRecruiting

Status

Recruiting

Phase

Phase 4

Enrollment

62

Locations

1

Results

Not posted

Publications

10

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

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.

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.

Timeline

From registration to results.

  1. First posted

    Nov 28, 2025

  2. Study start

    Mar 1, 2026

  3. Primary completion

    Nov 1, 2027

  4. Study completion

    Jan 2, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Mar 23, 2026

Outcomes

What the study measures.

Primary outcomes

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

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).

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.

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

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

Eligibility

Who can take part.

Minimum age
12 Years
Maximum age
18 Years
Sex
FEMALE
Healthy volunteers
No

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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Boston Children's Hospital

Norwood, Massachusetts, United States

Publications

Results and literature.

PMID 39527393 ↗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 17981168 ↗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 27811513 ↗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 11810167 ↗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 21098197 ↗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 38365902 ↗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 35512891 ↗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 27068617 ↗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 22149697 ↗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 37296488 ↗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.

Primary links

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