Clinical trial

SporTRIA Study: A Multicentre Trial for Excretion Kinetics of Triamcinolone Acetonide Following Sport Related Intra-articular Injections in Knees; Definitions of the Washout Periods

Name
2020-A01448-31
Description
Intra-articular and peri-articular glucocorticoid (GC) injections are common in sports medicine. However, from 1st January 2022, all injectable GC routes (including intra-articular administration (IA)) will be prohibited in-competition by World Anti-Doping Agency (WADA). Due to these rules, an IA GC treatment out-of-competition could result in an adverse analytical finding (AAF) in-competition if the washout period is not clearly defined. The aim of this study is to determine the urinary excretion profile of triamcinolone acetonide following IA to help in the definition of the washout periods.
Trial arms
Trial start
2023-01-01
Estimated PCD
2024-12-01
Trial end
2024-12-01
Status
Recruiting
Treatment
knee intra-articular infiltration with Triamcinolone acetonide
knee intra-articular intra-articular ultrasound-guided infiltration of Triamcinolone acetonide
Arms:
athletic subjects
Size
20
Primary endpoint
Determination of the excretion profile of triamcinolone acetonide in urine following intra-articular ultrasound-guided injection
Change from baseline, pre-injection (day 0) to date (up to 35 days) where glucocorticoids urinary value below the 15 ng/ml
Eligibility criteria
Inclusion Criteria: * Sports practice at least 4h / week * No comorbidities against indicating intra-articular knee injection * Subject with a knee disease requiring intra-articular injection of GCs Exclusion Criteria: * Subject with glucocorticoid (GC) allergy or GC medical contraindication * Pregnant women or women of childbearing potential without effective contraception * Washout period of all injectable routes and systemic use of GCs less than 3 months
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2023-02-27

1 organization

1 product

2 indications

Organization
Central Hospital
Indication
Glucocorticoids