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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| athletic subjects | Other | athletic subjects who may need intra-articular knee infiltration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| knee intra-articular infiltration with Triamcinolone acetonide | Drug | knee intra-articular intra-articular ultrasound-guided infiltration of Triamcinolone acetonide |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Régional Universitaire de Nancy. | Recruiting | Vandœuvre-lès-Nancy | 54500 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34108168 | Derived | 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. |
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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
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| 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 |
| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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