Hoffa's Fat Pad Impingement (HFPI)

Официальное название

Hoffa's Fat Pad Impingement (HFPI): Saline Injection Verus Ultrasound Guided Cortisone Injection: A Randomized Trial in Adolescent Female Athletes

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• International Knee Documentation Committee (IKDC Score) [Срок оценки: From enrollment to 8 weeks after enrollment]

Вторичные конечные точки (4)

• Peds Quality of Life Score (Peds-QL) [Срок оценки: From enrollment to 8 weeks after enrollment]
• Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (PISF) [Срок оценки: From enrollment to 8 weeks after enrollment]
• Level of Activity per week [Срок оценки: From enrollment to 8 weeks after enrollment]
• Self-report pain flare post injection [Срок оценки: 4 weeks post injection]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Boston Children's Hospital — Norwood

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07255248 · IRB-P00051842

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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