- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07651215
Radiographic and Clinical Outcomes After Short-Stem Reverse Shoulder Arthroplasty (STEP2yrs)
Humeral-Sided Radiographic Changes and Clinical Outcome After Reverse Total Shoulder Arthroplasty With Short Stem - Minimum 2-Year Follow-Up
Reverse total shoulder arthroplasty (RTSA) has become increasingly common in recent years due to expanding indications and improved surgical techniques. Short-stem humeral implants have gained attention because they preserve bone stock, allow metaphyseal fixation, and facilitate potential revision procedures.
The aim of this study is to evaluate radiographic and clinical outcomes following reverse shoulder arthroplasty with a short humeral stem after a minimum follow-up of two years. Patients who underwent RTSA at the Department of Orthopedics at Ordensklinikum Linz will be invited for clinical and radiographic follow-up.
Clinical outcomes will be assessed using established shoulder scores including the Constant Score, the American Shoulder and Elbow Surgeons (ASES) score, and the Simple Shoulder Test (SST). Radiographic evaluation will focus on humeral-sided changes such as stress shielding, radiolucent lines, osteolysis, and fractures. Patient satisfaction will additionally be assessed using visual analogue scales and patient-reported outcome measures.
Demographic variables, comorbidities, and implant-related characteristics will be collected to allow descriptive evaluation of factors potentially associated with clinical and radiographic outcomes.
Panoramica dello studio
Stato
Descrizione dettagliata
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Luoghi di studio
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Linz, Austria, 3340
- Ordensklinikum Linz - Barmherzige Schwester
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
The study population consists of adult patients who underwent reverse total shoulder arthroplasty with a short humeral stem at the Department of Orthopedics, Ordensklinikum Linz, Austria. All eligible patients who received this procedure at least two years prior to enrollment will be invited for a clinical and radiographic follow-up examination.
Participants are identified through institutional medical records and include both male and female patients. Only patients who provide written informed consent will be included in the study.
Descrizione
Inclusion Criteria:
- Reverse shoulder arthroplasty with short humeral stem
- Surgery performed at Ordensklinikum Linz
- Minimum postoperative follow-up of 2 years
- Written informed consent
Exclusion Criteria:
- Perioperative complications not related to the surgical procedure
- Lack of consent for study participation
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Radiographic Changes of the Humeral Component
Lasso di tempo: ≥2 years postoperatively
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Assessment of humeral-sided radiographic changes including: Stress shielding Radiolucent lines Osteolysis Periprosthetic fractures Measured using standardized radiographs at follow-up. |
≥2 years postoperatively
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Constant-Murley Score (Constant Score)
Lasso di tempo: up to 3 years postoperatively
|
The Constant Score is a comprehensive shoulder function assessment.
The total score ranges from 0 to 100 points.
Higher scores indicate better shoulder performance and function; lower scores indicate greater functional impairment and symptoms.
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up to 3 years postoperatively
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American Shoulder and Elbow Surgeons Score (ASES)
Lasso di tempo: up to 3 years postoperatively
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The American Shoulder and Elbow Surgeons Score is used to assess shoulder pain and function.
The total score ranges from 0 to 100 points.
Higher scores indicate better shoulder function, less pain, and fewer activity limitations; lower scores indicate greater pain, impaired shoulder function, and increased disability.
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up to 3 years postoperatively
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Simple Shoulder Test Score (SST)
Lasso di tempo: up to 3 Years Postoperatively
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Shoulder function will be assessed using the Simple Shoulder Test.
The total score ranges from 0 to 12 points.
Higher scores indicate better shoulder function.
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up to 3 Years Postoperatively
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Return to Sport Rate (RTS)
Lasso di tempo: up to 3 years postoperatively
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Return to sport will be assessed as the proportion or percentage of patients who returned to sport participation after surgery.
Higher percentages indicate a better outcome, reflecting a greater rate of successful return to sport.
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up to 3 years postoperatively
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 1035/2026
Piano per i dati dei singoli partecipanti (IPD)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .