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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07645508
Acronym
STEP-AR
Enrollment
50
Registered
2026-06-12
Start date
2023-11-01
Completion date
2026-12-01
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Arthroplasty

Keywords

Reverse Total Shoulder Arthroplasty, Patient-Specific Instrumentation, Augmented Reality Navigation, Glenoid Positioning, CT Accuracy, Functional Outcome

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.

Interventions

None listed

Sponsors

Krankenhaus Barmherzige Schwestern Linz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of Glenoid Component Positioningup to 2years postoperativelyComparison of preoperative planning parameters with postoperative CT-based measurements of glenoid component positioning, including inclination, version, implant size, and screw placement.

Secondary

MeasureTime frameDescription
Constant-Murley Score (Constant Score)2 years postoperativelyThe 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.
American Shoulder and Elbow Surgeons (ASES)2 years postoperativelyShoulder 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.
Disabilities of the Arm, Shoulder and Hand Score (DASH)2 years postoperativelyThe 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.
Complications and Revision SurgeryUp to 2 years postoperativelyOccurrence of complications or revision procedures.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026