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Active, Not Recruiting

NCT Number: NCT07645508

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Shoulder Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ordensklinikum Linz - Barmherzige Schwestern

Linz, 4020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Accuracy of Glenoid Component Positioning

    Time frame: 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.

Secondary outcomes

  1. Constant-Murley Score (Constant Score)

    Time frame: 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. American Shoulder and Elbow Surgeons (ASES)

    Time frame: 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.

  3. Disabilities of the Arm, Shoulder and Hand Score (DASH)

    Time frame: 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.

  4. Complications and Revision Surgery

    Time frame: Up to 2 years postoperatively

    Occurrence of complications or revision procedures.

Sponsors and collaborators

Lead sponsor

Krankenhaus Barmherzige Schwestern Linz

Other

Registry information

Official study title

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

Acronym: STEP-AR

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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