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Radiographic and Clinical Outcomes After Short-Stem Reverse Shoulder Arthroplasty (STEP2yrs)

10. juni 2026 opdateret af: Krankenhaus Barmherzige Schwestern Linz

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.

Studieoversigt

Status

Tilmelding efter invitation

Detaljeret beskrivelse

Retrospective with prospective follow-up

Undersøgelsestype

Observationel

Tilmelding (Anslået)

50

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Linz, Østrig, 3340
        • Ordensklinikum Linz - Barmherzige Schwester

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Radiographic Changes of the Humeral Component
Tidsramme: ≥2 years postoperatively

Assessment of humeral-sided radiographic changes including:

Stress shielding Radiolucent lines Osteolysis Periprosthetic fractures

Measured using standardized radiographs at follow-up.

≥2 years postoperatively

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Constant-Murley Score (Constant Score)
Tidsramme: 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.
up to 3 years postoperatively
American Shoulder and Elbow Surgeons Score (ASES)
Tidsramme: 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.
up to 3 years postoperatively
Simple Shoulder Test Score (SST)
Tidsramme: up to 3 Years Postoperatively
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.
up to 3 Years Postoperatively
Return to Sport Rate (RTS)
Tidsramme: up to 3 years postoperatively
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.
up to 3 years postoperatively

Samarbejdspartnere og efterforskere

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Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. februar 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 1035/2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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