Corticosteroid Injection for Hoffa's Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of a corticosteroid injection for treating knee pain from Hoffa's Fat Pad Impingement in young female athletes. Participants will receive either a corticosteroid injection (Methylprednisolone Acetate) or a saline injection, both combined with physical therapy, to determine which approach better alleviates pain and improves activity levels. Ideal candidates are girls aged 12-18 who play organized sports and continue to experience knee pain despite completing a physical therapy regimen. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand its benefits for more patients.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. However, you cannot receive other knee injections during the study period.
What is the safety track record for these treatments?
Research has shown that corticosteroid injections, like the one under study, are generally safe and well-tolerated. Studies have found that these injections can reduce knee pain and swelling without causing major side effects. Most patients experience only mild discomfort during the injection itself.
The specific corticosteroid used in this study, methylprednisolone acetate, has already received FDA approval for other uses, indicating its safety for people. In studies with patients who have knee osteoarthritis, these injections did not cause serious side effects.
In summary, corticosteroid injections are considered safe, with research supporting their use for reducing knee pain and inflammation in various conditions.12345Why are researchers enthusiastic about this study treatment?
Unlike standard treatments for Hoffa's Syndrome, which typically involve physical therapy and non-steroidal anti-inflammatory drugs (NSAIDs), the corticosteroid injection being studied offers a targeted approach. Researchers are excited because this treatment uses methylprednisolone acetate, a potent anti-inflammatory steroid, and it's delivered directly into the affected area using ultrasound guidance. This precise delivery method can potentially reduce inflammation more effectively and provide quicker symptom relief compared to traditional systemic treatments.
What evidence suggests that this trial's treatments could be effective for Hoffa's Syndrome?
Research has shown that corticosteroid injections, which participants in this trial may receive, reduce knee pain more effectively than a placebo. For example, a review found that these injections offer short-term pain relief compared to a saltwater injection. Specifically, injections into the infrapatellar fat pad (a small cushion of fat under the kneecap) demonstrated significant pain relief and improved knee function after six months. However, some studies suggest that the improvements might not be dramatic for everyone, especially those with knee osteoarthritis. Overall, evidence supports that corticosteroid injections effectively reduce pain for people with issues related to the infrapatellar fat pad, such as Hoffa’s Syndrome.12346
Who Is on the Research Team?
Julie Han, M.D.
Principal Investigator
Boston Children's Hospital
Are You a Good Fit for This Trial?
This trial is for girls aged 12-18 who play organized sports, have ongoing knee pain from Hoffa's Fat Pad Impingement (HFPI), and have already tried physical therapy. They must have had specific knee exams and imaging done.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a corticosteroid injection with physical therapy or a saline injection with physical therapy
Follow-up
Participants are monitored for treatment outcomes, including quality of life, pain interference, symptoms, and function
What Are the Treatments Tested in This Trial?
Interventions
- Methylprednisolone Acetate
- Saline Injection
- US-guided Hoffa's Fat Pad Corticosteroid Injection
Trial Overview
The study compares two treatments for HFPI: one group gets a steroid plus numbing injection into the knee along with physical therapy, while the other group receives a saline (placebo) injection with physical therapy. Participants are randomly assigned to each group.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Children's Hospital
Lead Sponsor
Citations
NCT07255248 | Hoffa's Fat Pad Impingement (HFPI)
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 ...
Efficacy and safety of GLucocorticoid injections into ... - PMC
This GLITTERS trial aims to investigate if a glucocorticoid injection into the IPFP is effective and safe over 12 weeks among knee OA patients with an ...
Hoffa's disease: A report on 5 cases
Injections of corticosteroids into Hoffa's fat pad may also be effective [14]. In case of failure of conservative treatment or if Hoffa's disease has become ...
Comparison of the effectiveness of intra-infrapatellar fat pad ...
Primary outcomes are (1) Hoffa's synovitis improvement rate, measured with the MRI Osteoarthritis Knee Score system (superiority outcome) at 24 ...
Infrapatellar Fat Pad Glucocorticoid Injection in Knee ...
A systematic review found that intra-articular glucocorticoid injections were effective in reducing pain compared with placebo in the short ...
Exploratory pilot study of infrapatellar fat pad inflammation and ...
This exploratory pilot study assessed infrapatellar fat pad (IPFP) inflammation using Doppler ultrasound in patients with knee osteoarthritis ( ...
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