- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Detaillierte Beschreibung
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienorte
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Linz, Österreich, 3340
- Ordensklinikum Linz - Barmherzige Schwester
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Radiographic Changes of the Humeral Component
Zeitfenster: ≥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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Constant-Murley Score (Constant Score)
Zeitfenster: 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)
Zeitfenster: up to 3 years postoperatively
|
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)
Zeitfenster: 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)
Zeitfenster: 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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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 1035/2026
Plan für individuelle Teilnehmerdaten (IPD)
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