Treatment comparison for Hoffa's fat pad impingement in teenage female athletes
Hoffa's Fat Pad Impingement (HFPI): Saline Injection Verus Ultrasound Guided Cortisone Injection: A Randomized Trial in Adolescent Female Athletes
This will test whether an ultrasound-guided corticosteroid injection plus physical therapy helps teenage female athletes with Hoffa's fat pad impingement more than a saline injection plus physical therapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | Female |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Norwood, Massachusetts) |
| Trial ID | NCT07255248 on ClinicalTrials.gov |
What this trial studies
This randomized Phase 4 interventional trial enrolls female athletes aged 12–18 with refractory anterior knee pain diagnosed as Hoffa's fat pad impingement who have completed 6–8 weeks of physician-prescribed physical therapy. Participants are randomized to receive an ultrasound-guided methylprednisolone-lidocaine injection plus continued physical therapy versus a saline injection plus continued physical therapy. Investigators will measure treatment outcomes such as pain, function, and return-to-sport over follow-up, and the protocol is not focused on testing the safety or efficacy of the lidocaine-methylprednisolone mixture itself. Baseline X-ray and non-contrast MRI of the symptomatic knee are required and standard exclusion criteria (for example patellar instability or connective tissue disorders) are applied.
Who should consider this trial
Good fit: Ideal candidates are female athletes aged 12–18 with clinician-diagnosed Hoffa's fat pad impingement who have X-ray and MRI of the symptomatic knee and have completed a 6–8 week course of prescribed physical therapy.
Not a fit: Patients who are male, outside the 12–18 age range, have alternative knee diagnoses such as patellar instability or tendinopathy, or have connective tissue disorders like Ehlers-Danlos are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, the corticosteroid plus physical therapy approach could shorten pain duration and speed return to sport for affected athletes.
How similar studies have performed: Small adult case series and nonrandomized reports have shown short-term pain relief from corticosteroid injections into the infrapatellar fat pad, but randomized data in pediatric athlete populations are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Norwood, Massachusetts
- Boston Children's Hospital — Norwood, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Julie Han, M.D. — Boston Children's Hospital
- Study coordinator: Olivia Elie, B.S.
- Email: olivia.elie@childrens.harvard.edu
- Phone: 781-953-1086
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.