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

Not Applicable

Recruiting

• Conditions: Glucocorticoids; Doping in Sport
• Interventions: Drug: knee intra-articular infiltration with Triamcinolone acetonide

• Registration Number: NCT04574232
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-18
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-10-05
• Study Start: 2023-01-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-27
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
athletic subjects	knee intra-articular infiltration with Triamcinolone acetonide	athletic subjects who may need intra-articular knee infiltration

Primary Outcome Measures

Name	Time	Method
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	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)

Secondary Outcome Measures

Name	Time	Method
Modeling of the excretion profile of triamcinolone acetonide in urine following intra-articular ultrasound-guided injection.	evolution glucocorticoids urinary value from baseline, pre-injection (day 0) to Day 35	Evolution of urinary triamcinolone acetonide concentration
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 glucocorticoids blood value from baseline, pre-injection (day 0) to Day 35	Evolution of blood triamcinolone acetonide concentration
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.	Change from baseline, pre-injection (day 0) glucocorticoids DBS value up to 35 days	Mesure of blood exogenous corticosteroids on endogenous steroidsconcentration

Trial Locations

Locations (1)

Centre Hospitalier Régional Universitaire de Nancy.; 🇫🇷 Vandoeuvre les nancy, France