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L'essai clinique NCT07255248 pour Hoffa's Fat Pad Impingement est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Hoffa's Fat Pad Impingement (HFPI)

Pas encore en recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'étude clinique NCT07255248 est un essai interventionnel pour Hoffa's Fat Pad Impingement. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 17 novembre 2025, avec un objectif de 62 participants. Dirigé par Boston Children's Hospital, l'essai devrait être terminé d'ici le 2 janvier 2028. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 28 novembre 2025.
Résumé succinct
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.
Titre officiel

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

Conditions
Hoffa's Fat Pad Impingement
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'essai
  • IRB-P00051842
Numéro NCT
NCT07255248
Date de début (réel)
2025-11-17
Dernière mise à jour publiée
2025-11-28
Date de fin (estimée)
2028-01-02
Inscription (estimée)
62
Type d'essai
Interventionnel
PHASE
N/A
Statut
Pas encore en recrutement
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Simple aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
Comparateur 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.
Comparateur actifIntervention 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.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
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
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
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
Critères d'éligibilité

Âges éligibles
Enfant, Adulte
Âge minimum
12 Years
Sexes éligibles
Femme

  • • 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 Hospital logoBoston Children's Hospital
Partie responsable de l'essai
Julie Han, Investigateur principal, Julie Han, M.D., Boston Children's Hospital
Contact central de l'essai
Contact: Olivia Elie, B.S., 781-953-1086, [email protected]
Contact: Dai Sugimoto, PhD, [email protected]
Aucune donnée sur les lieux ou centres d'investigation disponible