62 Participants NeededMy employer runs this trial

Corticosteroid Injection for Hoffa's Syndrome

OE
DS
Overseen ByDai Sugimoto, PhD
Age: < 65
Sex: Female
Trial Phase: Phase 4
Sponsor: Boston Children's Hospital
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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?

JH

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

I have finished a 6-8 week physical therapy program as prescribed by my doctor.
I have been diagnosed with pain in the knee's fat pad area.
I am a female aged between 12 and 18 years.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a corticosteroid injection with physical therapy or a saline injection with physical therapy

8 weeks
1 visit (in-person) for injection, ongoing physical therapy

Follow-up

Participants are monitored for treatment outcomes, including quality of life, pain interference, symptoms, and function

8 weeks
Patient-reported outcomes at 4 and 8 weeks post-injection

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

Group I: Intervention Group: Corticosteroid InjectionActive Control1 Intervention
Group II: Control Group: Saline InjectionPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

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 ( ...