Clinical trial NCT04574232: SporTRIA Study: A Multicentre Trial for Excretion Kinetics of Triamcinolone Acetonide Following Sport Related Intra-articular Injections in Knees; Definitions of the Washout Periods
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Doping in Sport
Glucocorticoids
Keywords: glucocordicoids
Doping
sport
urinary
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Determination of the excretion profile of triamcinolone acetonide in urine following intra-articular ultrasound-guided injection
timeFrame: Change from baseline, pre-injection (day 0) to date (up to 35 days) where glucocorticoids urinary value below the 15 ng/ml
Secondary outcomes:
measure: Modeling of the excretion profile of triamcinolone acetonide in urine following intra-articular ultrasound-guided injection.
timeFrame: evolution glucocorticoids urinary value from baseline, pre-injection (day 0) to Day 35
measure: Determination of the excretion profile of cortisol in urine following intra-articular ultrasound-guided injection to evaluate systemic effect
timeFrame: Change from baseline, pre-injection (day 0) glucocorticoids urinary value up to 35 days
measure: Determination of the excretion profile of triamcinolone acetonide in DBS anti-doping test following intra-articular ultrasound-guided injection.
timeFrame: Change from baseline, pre-injection (day 0) glucocorticoids DBS value up to 35 days
measure: Modeling of the excretion profile of triamcinolone acetonide in DBS anti-doping test following intra-articular ultrasound-guided injection.
timeFrame: evolution glucocorticoids blood value from baseline, pre-injection (day 0) to Day 35
measure: Determination of cortisol levels in DBS to evaluate systemic effect
timeFrame: Change from baseline, pre-injection (day 0) glucocorticoids DBS value up to 35 days
measure: Identification of GCs on hair mark presence one month after intra-articular ultrasound-guided injection of triamcinolone acetonide.
timeFrame: Change from baseline, pre-injection (day 0) glucocorticoids hair value up to 35 days
measure: Evaluation of the impact of exogenous corticosteroids on endogenous steroids profile (androgens and GCs) in DBS samples.
timeFrame: Change from baseline, pre-injection (day 0) glucocorticoids DBS value up to 35 days
Other outcomes:
Locations:
city: Vandoeuvre les nancy
country: France
facility: Centre Hospitalier Régional Universitaire de Nancy.
Study officials:
References:
citation: Allado E, Poussel M, Gambier N, Saunier V, Starck M, Buisson C, Cinquetti G, Albuisson E, Chenuel B. SporTRIA study-a multicentre trial protocol for excretion kinetics of triamcinolone acetonide following sport-related intra-articular injections in knees: definitions of the washout periods. BMJ Open. 2021 Jun 9;11(6):e047548. doi: 10.1136/bmjopen-2020-047548.