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Comparison of Conventional, Patient-Specific, and Augmented Reality Navigation in Reverse Total Shoulder Arthroplasty (STEP-AR)

11. juni 2026 opdateret af: Krankenhaus Barmherzige Schwestern Linz

Comparison of Conventional, Patient-Specific, and Augmented Reality Navigation in Reverse Total Shoulder Arthroplasty: CT-Based Glenoid Positioning Accuracy and Functional Outcomes

This monocentric observational cohort study compares conventional instrumentation, patient-specific instrumentation, and augmented reality navigation in reverse total shoulder arthroplasty. The primary objective is to assess the accuracy of glenoid component positioning based on postoperative CT data. Secondary objectives include evaluation of functional outcomes and clinical performance at mid-term follow-up. Patients who underwent surgery between 2021 and 2024 are followed up clinically at 2 years postoperatively.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Detaljeret beskrivelse

This study investigates the accuracy and clinical relevance of different planning and implementation techniques in reverse total shoulder arthroplasty. Patients treated at a single orthopedic center between 2021 and 2024 were included. Three established surgical approaches were analyzed: conventional instrumentation, patient-specific instrumentation, and augmented reality navigation.

Initial data collection included retrospective and prospective assessment of preoperative planning parameters and their intraoperative implementation. Postoperative evaluation included low-dose CT imaging to assess glenoid component positioning accuracy.

The current phase of the study focuses on long-term clinical outcomes, with a standardized 2-year follow-up including clinical examination and validated functional outcome scores. No additional imaging is performed as part of the follow-up phase.

Patients were not randomized; group allocation reflects the surgical technique used at the time of treatment.

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

  • Østrig
      • Linz, Østrig, 4020
        • Ordensklinikum Linz - Barmherzige Schwestern

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

Patients who underwent reverse total shoulder arthroplasty at a single tertiary orthopedic center (Ordensklinikum Linz - Barmherzige Schwestern, Austria) between 2021 and 2024. The study population includes individuals treated using conventional instrumentation, patient-specific instrumentation, or augmented reality navigation as part of routine clinical care. Only patients with available preoperative planning data and postoperative CT imaging, as well as those eligible for clinical follow-up, were included. All participants are invited for a standardized clinical and functional assessment at 2 years postoperatively.

Beskrivelse

Inclusion Criteria:

  • Age ≥ 18 years
  • Reverse total shoulder arthroplasty performed between 2021 and 2024
  • Available preoperative imaging and planning (X-ray and/or CT)
  • Available postoperative CT imaging
  • Written informed consent

Exclusion Criteria:

  • Major perioperative complications not related to the shoulder procedure affecting outcomes
  • Incomplete imaging or clinical data

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Conventional Instrumentation
Patients who underwent reverse total shoulder arthroplasty using conventional surgical techniques.
Patient-Specific Instrumentation
Patients who underwent reverse total shoulder arthroplasty using patient-specific instrumentation based on preoperative planning.
Augmented Reality Navigation
Patients who underwent reverse total shoulder arthroplasty using augmented reality-assisted navigation (NEXTAR system).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Accuracy of Glenoid Component Positioning
Tidsramme: up to 2years postoperatively
Comparison of preoperative planning parameters with postoperative CT-based measurements of glenoid component positioning, including inclination, version, implant size, and screw placement.
up to 2years postoperatively

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Constant-Murley Score (Constant Score)
Tidsramme: 2 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.
2 years postoperatively
American Shoulder and Elbow Surgeons (ASES)
Tidsramme: 2 years postoperatively
Shoulder pain and function will be assessed using the American Shoulder and Elbow Surgeons Score. The total score ranges from 0 to 100 points. Higher scores indicate less pain and better shoulder function.
2 years postoperatively
Disabilities of the Arm, Shoulder and Hand Score (DASH)
Tidsramme: 2 years postoperatively
The Disabilities of the Arm, Shoulder and Hand Score measures disability and symptoms affecting the upper extremity, including the arm, shoulder, and hand. The total score ranges from 0 to 100 points. Lower scores indicate better upper-limb function and fewer symptoms; higher scores indicate greater disability and functional limitations.
2 years postoperatively
Complications and Revision Surgery
Tidsramme: Up to 2 years postoperatively
Occurrence of complications or revision procedures.
Up to 2 years postoperatively

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Krankenhaus Barmherzige Schwestern Linz

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. november 2023

Primær færdiggørelse (Faktiske)

31. december 2025

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

11. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 1264/2023

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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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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