Trinity ELITE (Trinity ELITE)
✓ ApprovedOrthofix · Cell-based Therapies · Cell-based Therapies
What is Trinity ELITE?
Trinity ELITE is a cell-based therapies developed by Orthofix. It is approved for therapeutic indications via injectable (others).
Drug Profile
| Brand Names | Trinity ELITE |
| Company | Orthofix |
| Drug Class | Cell-based Therapies |
| Route | Injectable (Others) |
| Status | Approved |
Therapeutic Indications
Trinity ELITE is developed for 1 unique indication across 1 therapeutic area.
| Therapeutic Area | Condition | Phase |
|---|---|---|
| Musculoskeletal and connective tissue disorders | Musculoskeletal disorder | ✓ Approved |
Related Research Articles
Does the different function of the lead vs. trail foot lead to functional asymmetry in balance performance of sub-elite youth cross-country mountain bikers? A pilot study.
Limpach Sam S, Lauer Matthias M, Schreiber Moritz M, Borgmann Katharina K et al.
During descents, cornering, or coasting over obstacles, cross-country mountain bikers use an isometric split stance with horizontally aligned pedals, establishing a distinct "lead" and "trail" leg. This pilot study investigated whether the different functions of the lead compared to the trail foot are associated with inter-limb functional asymmetry (FA) in proactive and reactive balance performance. Twelve sub-elite youth cross-country mountain bikers (10 males, age: 13.5 ± 1.7 years, training history: 4.7 years) were assessed. Proactive balance was evaluated using the Y-Balance Test-Lower Quarter (YBT-LQ). Reactive balance was assessed via Time to Stabilization (TTS) during single-leg drop landings. Statistical analyses utilized Kruskal-Wallis H-tests and Wilcoxon signed-rank tests to compare performance differences between the lead and trail leg. No significant differences between the lead and trail leg were observed across any reach directions or the composite score of the YBT-LQ. Contrarily, TTS revealed a significant difference (Z = 2.59, p = .010, r = .75) for the mediolateral plane, with the lead leg having a faster TTS. Chronic participation in mountain biking was associated with an FA in measures of reactive balance specifically isolated to the ML plane. Since off-road descents present unpredictable, high-speed perturbations, the rider must rely heavily on a mediolateral "hip strategy." The superior reactive stabilization of the lead leg suggests that this specific FA could serve as a sport-specific performance indicator.
Deployability of machine-learning prediction models in elite and high-level team sports: a task-specific systematic review.
Guan Zhiyu Z, Jin Zicheng Z, Mao Chuangui C, Liu Weiguo W et al.
Machine-learning models are increasingly used for match forecasting and athlete monitoring in elite and high-level team sports, but high reported performance does not necessarily indicate readiness for real-world use. This systematic review evaluated whether models were developed and tested under conditions compatible with their intended decision time. Eight databases were searched, with searches completed by 12 July 2026. Eighty reports representing 77 studies contributed 87 analysis units: 55 Core, 23 post-event or high-leakage Comparators, and nine Boundary units. All 87 units were assessed for deployable prediction validity (DPV) across six domains, and 78 Core or Comparator units were also assessed with PROBAST. Amongst Core units, 26/55 (47.3%) were rated at least Moderate, including five Moderate-to-strong and 21 Moderate units. Pre-adjudication agreement for the overall DPV classification was 85/87 (97.7%; κ = 0.968; linearly weighted κ = 0.978), whilst domain-level exact agreement ranged from 75/87 to 87/87. In post hoc sensitivity analyses, 19/55 Core units met the primary DPV threshold and had Sufficient validation; 14/55 met the primary threshold and had at least partial evidence of predictive reliability or probability-quality; and 9/55 met the primary threshold and both additional conditions. PROBAST risk of bias was High for 56/78 units, Unclear for 21/78, and Low for one. The main limitations were evaluation designs that did not adequately reflect intended future use and limited assessment of predictive reliability. Overall, the evidence supports selective methodological readiness rather than general deployability, with different requirements for pre-game, in-game, and athlete-monitoring applications. https://www.crd.york.ac.uk/PROSPERO/view/CRD420261425179 , identifier CRD420261425179.
Chronic traumatic encephalopathy in a neuropathologically confirmed Creutzfeldt-Jakob disease cohort.
Bertran Lluc L, Aldecoa Iban I, Sindikubwabo Arlène A, Vidal Núria N et al.
Chronic traumatic encephalopathy (CTE) is a tauopathy associated with repetitive head impacts, experienced most commonly in contact sports; however, its relationship with prion diseases remains unclear. Postmortem CTE screening using phosphorylated tau staining was conducted at the Neurological Tissue Bank of Hospital Clínic-IDIBAPS on hippocampal and frontal cortex samples from patients with neuropathologically confirmed Creutzfeldt-Jakob disease (CJD), blinded to patients' clinical histories. In positive and suggestive cases, the analysis was expanded in accordance with the NINDS/NIBIB consensus criteria for CTE, and clinical and neuropathological information was reviewed. CTE was detected in 3 out of 212 CJD cases (1.4%), all with severe CTE pathology: 2 former soccer players (one of them an elite player) and 1 former rugby player. All had started playing sports between the first and second decades of life and ended in the fifth. The clinical presentation of CJD was heterogeneous, with different initial symptoms in each case. Neuropathological examination revealed an MM1/MV1 histotype in the soccer players and a VV2 histotype in the rugby player, the first- and second-most common variants in CJD, respectively. These three cases illustrate the coexistence of CTE and CJD across heterogeneous clinicopathological presentations. Further studies are needed to determine whether shared mechanisms may contribute to the coexistence of both pathologies.
Effects of psychological skills training on self-control, perceived physical self-defense capacity, and mental toughness in elite female wrestlers: a randomized controlled trial.
Tutal Varol V, Demir Okan O, Şahin Oktay O, Albayrak Ahmet Yılmaz AY et al.
Self-control, self-defense self-efficacy, and mental resilience are fundamental psychological determinants of performance and competitive endurance in combat sports. However, scientific evidence on structured, evidence-based psychological intervention programs for professional female wrestlers remains limited. This study examined the effects of a psychological skills training (PST)-based intervention on self-control, self-defense self-efficacy, and mental resilience in professional female wrestlers. A randomized controlled pre-test-post-test design was employed. Thirty-six professional female wrestlers (aged 18-25) were randomly assigned to a PST group (n = 18) or a control group (CG; n = 18). The PST group completed an 8-week structured psychological intervention alongside regular training, while the CG continued routine training only. Self-control, self-defense self-efficacy, and mental resilience were assessed pre- and post-intervention using valid and reliable psychometric scales. Data were analyzed via repeated-measures ANOVA, with effect sizes calculated. Significant group × time interactions were observed across multiple outcomes. A highly significant interaction emerged for perceived physical self-defense capacity (SP; F(1,34) = 56.525, p < 0.001, ηp2 = 0.624) and for DP scores (F (1,34) = 9.360, p = 0.004, ηp2 = 0.216). Among self-control subscales, significant interactions were found for inhibition (F (1,34) = 8.172, p = 0.007, ηp2 = 0.194) and, more strongly, for initiation (F (1,34) = 14.157, p < 0.001, ηp2 = 0.294). For mental resilience, highly significant interactions were detected for confidence (F (1,34) = 59.976, p < 0.001, ηp2 = 0.638), control (F (1,34) = 32.486, p < 0.001, ηp2 = 0.489), and persistence (F (1,34) = 32.709, p < 0.001, ηp2 = 0.490). Overall, the intervention demonstrated medium-to-high effect sizes across psychological performance indicators. These findings suggest that PST may serve as a useful complementary approach for enhancing self-control, perceived physical self-defense capacity, and mental toughness in professional female wrestlers. However, results should not be interpreted as evidence of improved competitive wrestling performance, technical success, or objectively measured physical self-defense ability, as these outcomes were not directly assessed in this study.
Understanding safe sport as a public health practice: a strong structuration theory analysis of Swedish elite athletics sport personnel.
Lundqvist Carolina C, Jederström Moa M, Korhonen Laura L
Exposure to harmful environments and practices is reported across a wide range of sports, including athletics, with negative implications for participants' health and welfare across age groups, genders, and competitive levels. Sport environments are shaped by powerful cultural norms and organisational practices, which influence how sport personnel responsible for shaping elite athletes' sporting environments understand, prioritise and enact safety in practice. This study explores how sport personnel in Swedish elite athletics interpret and enact safe sport, and how these enactments are shaped, enabled, and constrained by structural conditions. Sport personnel (n = 17; 8 women, 9 men; aged 35-66) with responsibility for shaping elite athletes' sporting environments, including teachers and coaches at national elite sport high schools, managers of high-performance centres and national team head coaches, within Swedish Athletics were purposively sampled across elite organisational levels (i.e., national elite sport high schools, high-performance centres, national teams). Data were generated through semi-structured interviews. Analysis was conducted using reflexive thematic analysis within a social constructivist-informed qualitative framework. Stones' Quadripartite Nature of Structuration model, an extension of Strong Structuration Theory, informed the organisation and interpretation of themes and subthemes. Three themes describe how safe sport was understood, enacted, constrained, and transformed within Swedish elite athletics. Theme 1 addresses how sport personnel understood safe sport through the interplay between internal and external structures, including holistic understandings, temporal shifts, and resource conditions. Theme 2 reflects active agency through everyday practices, including collaborative agency and micro-level interventions. Theme 3 highlights structural constraints and opportunities for safe sport transformation, including solitary coaching practices, power asymmetries, institutional silence, performance norms that normalise harmful behaviours, fragmented accountability structures alongside ongoing efforts toward institutionalisation. Sport personnel described safe sport as extending beyond safeguarding and the prevention of harm to include broader organisational and sociocultural conditions that support athlete welfare. The findings position safe sport as a settings-based public health practice contingent on organisational conditions that strengthen sport personnel's agency and enable preventive action. Transformative change towards safe sport appears to require institutionalised prevention capacity, including clear accountability, and resources that extend beyond individual sport personnel's awareness and commitment.
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