Hoffa's Fat Pad Impingement (HFPI): Saline Injection Verus Ultrasound Guided Cortisone Injection: A Randomized Trial in Adolescent Female Athletes
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- International Knee Documentation Committee (IKDC Score)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Control 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.
干预措施: Saline injection (Octreotide LAR placebo) (Drug)
Intervention 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.
干预措施: methylprednisolone acetate and lidocaine (Drug)
结局指标
主要结局
International Knee Documentation Committee (IKDC Score)
时间窗: 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.
次要结局
- 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)
研究者
Julie Han
Principal Investigator
Boston Children's Hospital