Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

11 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Schouder artroplastiek

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Oostenrijk
- - Linz, Oostenrijk, 4020
    - Ordensklinikum Linz - Barmherzige Schwestern

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Accuracy of Glenoid Component Positioning Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Constant-Murley Score (Constant Score) Tijdsspanne: 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) Tijdsspanne: 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) Tijdsspanne: 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 Tijdsspanne: Up to 2 years postoperatively	Occurrence of complications or revision procedures.	Up to 2 years postoperatively

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Krankenhaus Barmherzige Schwestern Linz

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 november 2023

Primaire voltooiing (Werkelijk)

31 december 2025

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

1 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

11 juni 2026

Eerst geplaatst (Werkelijk)

12 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)