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Clinical Trials/NCT07645508
NCT07645508Active, not recruitingNot Applicable

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

Krankenhaus Barmherzige Schwestern Linz1 site in 1 country50 target enrollmentStarted: November 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
50
Locations
1

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor
Krankenhaus Barmherzige Schwestern Linz
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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