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

Study Overview
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Brief Summary
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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.

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

Conditions
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Doping in Sport, Glucocorticoids

Intervention / Treatment
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* Drug: knee intra-articular infiltration with Triamcinolone acetonide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: athletic subjects<br>athletic subjects who may need intra-articular knee infiltration | Drug: knee intra-articular infiltration with Triamcinolone acetonide<br>* knee intra-articular intra-articular ultrasound-guided infiltration of Triamcinolone acetonide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the excretion profile of triamcinolone acetonide in urine following intra-articular ultrasound-guided injection | For subjects with a glucocorticoids urinary value below the 15 ng/ml threshold at D0 (before injection), identification of the date (up to 35 days) following the intra-articular ultrasound-guided injection which will correspond in the standards of the World Agency (under 15 ng/ml) | Change from baseline, pre-injection (day 0) to date (up to 35 days) where glucocorticoids urinary value below the 15 ng/ml | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modeling of the excretion profile of triamcinolone acetonide in urine following intra-articular ultrasound-guided injection. | Evolution of urinary triamcinolone acetonide concentration | evolution glucocorticoids urinary value from baseline, pre-injection (day 0) to Day 35 | 
| Determination of the excretion profile of cortisol in urine following intra-articular ultrasound-guided injection to evaluate systemic effect |  | Change from baseline, pre-injection (day 0) glucocorticoids urinary value up to 35 days | 
| Determination of the excretion profile of triamcinolone acetonide in DBS anti-doping test following intra-articular ultrasound-guided injection. |  | Change from baseline, pre-injection (day 0) glucocorticoids DBS value up to 35 days | 
| Modeling of the excretion profile of triamcinolone acetonide in DBS anti-doping test following intra-articular ultrasound-guided injection. | Evolution of blood triamcinolone acetonide concentration | evolution glucocorticoids blood value from baseline, pre-injection (day 0) to Day 35 | 
| Determination of cortisol levels in DBS to evaluate systemic effect |  | Change from baseline, pre-injection (day 0) glucocorticoids DBS value up to 35 days | 
| Identification of GCs on hair mark presence one month after intra-articular ultrasound-guided injection of triamcinolone acetonide. |  | Change from baseline, pre-injection (day 0) glucocorticoids hair value up to 35 days | 
| Evaluation of the impact of exogenous corticosteroids on endogenous steroids profile (androgens and GCs) in DBS samples. | Mesure of blood exogenous corticosteroids on endogenous steroidsconcentration | Change from baseline, pre-injection (day 0) glucocorticoids DBS value up to 35 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glucocordicoids, Doping, sport, urinary