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

Glucocorticoids Clinical Trial

— SporTRIA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04574232
• Other study ID #: 2020-A01448-31
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Doping in Sport
• Glucocorticoids

Intervention

Drug:
• knee intra-articular infiltration with Triamcinolone acetonide
knee intra-articular intra-articular ultrasound-guided infiltration of Triamcinolone acetonide

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire de Nancy.	Vandoeuvre les nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Determination of cortisol levels in DBS to evaluate systemic effect		Change from baseline, pre-injection (day 0) glucocorticoids DBS value up to 35 days
Secondary	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
Secondary	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