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

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04574232

Collaborator

(none)

Enrollment

Location

Arm

27.9

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Doping in Sport Glucocorticoids	Drug: knee intra-articular infiltration with Triamcinolone acetonide	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Aug 6, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: athletic subjects athletic subjects who may need intra-articular knee infiltration	Drug: knee intra-articular infiltration with Triamcinolone acetonide knee intra-articular intra-articular ultrasound-guided infiltration of Triamcinolone acetonide

Arm

Intervention/Treatment

Other: athletic subjects

athletic subjects who may need intra-articular knee infiltration

Drug: knee intra-articular infiltration with Triamcinolone acetonide

knee intra-articular intra-articular ultrasound-guided infiltration of Triamcinolone acetonide

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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