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Hoffa's Fat Pad Impingement (HFPI)

Plain-language guide to NCT07255248: phase 4 randomized trial of Octreotide, 62 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07255248
Phase
phase 4
Status
recruiting participants
Start
2026-03-01
Completion (planned or actual)
2027-11-01
Participants
62 (estimated)
Design
randomized, single-blind, treatment
Conditions studied
Hoffa's Fat Pad Impingement
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 4 trial, researchers set out to test Octreotide.

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.

It had two arms (groups): Control Group: Saline Injection (placebo comparator) and Intervention Group: Corticosteroid Injection (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 62 planned participants were the target.

It was open to women only aged from 12 years up to 18 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 12-18 years. Patients who identify as female. 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.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

The Octreotide group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Octreotide was given.

Those kept unaware of assignments: participant.

It started in 2026-03-01 with completion listed for 2027-11-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: International Knee Documentation Committee (IKDC Score) (time frame: From enrollment to 8 weeks after enrollment).

It also tracked 4 secondary outcomes, for example Peds Quality of Life Score (Peds-QL), Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (PISF), Level of Activity per week and Self-report pain flare post injection.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Octreotide in 62 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.

Our Notes on the Compound

Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.