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

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.

Study Overview

• Status: Recruiting
• Conditions: Glucocorticoids; Doping in Sport
• Intervention / Treatment: Drug: knee intra-articular infiltration with Triamcinolone acetonide

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Vandoeuvre les nancy, France, 54500
    • Recruiting
    • Centre Hospitalier Régional Universitaire de Nancy.
    • Contact: Edem ALLADO, MD MSc; Phone Number: +33383858585; Email: e.allado@chru-nancy.fr
    • Principal Investigator: Edem ALLADO, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 of blood triamcinolone acetonide concentration	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
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.	Mesure of blood exogenous corticosteroids on endogenous steroidsconcentration	Change from baseline, pre-injection (day 0) glucocorticoids DBS value up to 35 days

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: sport; Doping; urinary; glucocordicoids
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: 2020-A01448-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The data from all patients will be centrally stored in Nancy. Data management will be carried out by CHRU de Nancy (Direction de la Recherche et de l'Innovation). The conditions for data transfer of all or part of the study database are decided by the study sponsor and are the subject of a written contract. This study and the data collected fall within the scope of Reference Methodology MR001.

The data may be transmitted to the companies in the group to which the promoter belongs and to its contractual partners in a form which should not permit the direct or indirect identification of persons lending themselves to research

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No