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Lo studio clinico NCT07255248 per Hoffa's Fat Pad Impingement è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Hoffa's Fat Pad Impingement (HFPI)
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07255248 è uno studio interventistico per Hoffa's Fat Pad Impingement, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 17 novembre 2025, con l'obiettivo di raggiungere 62 partecipanti. Sotto la guida di Boston Children's Hospital, dovrebbe concludersi entro il 2 gennaio 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 28 novembre 2025.
Sommario breve
The aim of our study is to investigate treatment outcomes for refractory anterior knee pain due to Hoffa's Fat Pad Impingement (HFPI) in young female athletes. Specifically, we 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 we are not looking at the safety and effectiveness of the lidocaine-methylprednisolone mixture.
Titolo ufficiale
Hoffa's Fat Pad Impingement (HFPI): Saline Injection Verus Ultrasound Guided Cortisone Injection: A Randomized Trial in Adolescent Female Athletes
Condizioni
Hoffa's Fat Pad ImpingementPubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Altri ID dello studio
- IRB-P00051842
Numero NCT
Data di inizio (effettiva)
2025-11-17
Ultimo aggiornamento pubblicato
2025-11-28
Data di completamento (stimata)
2028-01-02
Arruolamento (previsto)
62
Tipo di studio
Interventistico
FASE
N.D.
Stato
Non ancora in arruolamento
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Comparatore placeboControl 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. | 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. |
Comparatore attivoIntervention 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. | 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. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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. | From enrollment to 8 weeks after enrollment |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Peds Quality of Life Score (Peds-QL) | 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 (HRQL). | From enrollment to 8 weeks after enrollment |
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (PISF) | 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. | From enrollment to 8 weeks after enrollment |
Level of Activity per week | Patients will report hours of activity per week during the study | From enrollment to 8 weeks after enrollment |
Self-report pain flare post injection | Patients will self-report any pain flares that occur 4 weeks after receiving the injection | 4 weeks post injection |
Criteri di eleggibilità
Età idonea
Bambino, Adulto
Età minima
12 Years
Sessi idonei
Donna
• 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
• 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)
Boston Children's HospitalParte responsabile dello studio
Julie Han, Investigatore principale, Julie Han, M.D., Boston Children's Hospital
Contatti principali dello studio
Contatto: Olivia Elie, B.S., 781-953-1086, [email protected]
Contatto: Dai Sugimoto, PhD, [email protected]
Nessun dato sui località