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

NCT04574232 | Unknown

• 1 other identifier: 2020-A01448-31
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Doping in Sport; Glucocorticoids

Keywords

glucocordicoids; Doping; sport; urinary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• 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

• Determination of cortisol levels in DBS to evaluate systemic effect

  Change from baseline, pre-injection (day 0) glucocorticoids DBS value up to 35 days

Study Arms (1)

athletic subjects

OTHER

athletic subjects who may need intra-articular knee infiltration

Drug: knee intra-articular infiltration with Triamcinolone acetonide

Interventions

knee intra-articular infiltration with Triamcinolone acetonide DRUG

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

athletic subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Centre Hospitalier Régional Universitaire de Nancy.

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 34108168 DERIVED

MeSH Terms

Interventions

Triamcinolone Acetonide

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: October 5, 2020
• Study Start: January 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)