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

NCT07645508 | Active Not Recruiting

• 1 other identifier: 1264/2023
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Arthroplasty

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Accuracy of Glenoid Component Positioning

  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

Secondary Outcomes (4)

• Constant-Murley Score (Constant Score)

  2 years postoperatively

• American Shoulder and Elbow Surgeons (ASES)

  2 years postoperatively

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

  2 years postoperatively

• Complications and Revision Surgery

  Up to 2 years postoperatively

Study Arms (3)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Krankenhaus Barmherzige Schwestern Linz: lead

Study Sites (1)

Ordensklinikum Linz - Barmherzige Schwestern

Linz, 4020, Austria

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 12, 2026
• Study Start: November 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

AU (1)