Shoulder ArthroplastySTEP-ARNCT07645508
Comparison of Conventional, Patient-Specific, and Augmented Reality Navigation in Reverse Total Shoulder Arthroplasty
An observational study of Shoulder Arthroplasty, run by Krankenhaus Barmherzige Schwestern Linz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Arthroplasty
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Major perioperative complications not related to the shoulder procedure affecting outcomes
- Incomplete imaging or clinical data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Shoulder Arthroplasty
- Keywords
- Reverse Total Shoulder Arthroplasty, Patient-Specific Instrumentation, Augmented Reality Navigation, Glenoid Positioning, CT Accuracy, Functional Outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2years postoperatively
Secondary outcomes (4)
Constant-Murley Score (Constant Score)
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.
Measured: 2 years postoperatively
American Shoulder and Elbow Surgeons (ASES)
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.
Measured: 2 years postoperatively
Disabilities of the Arm, Shoulder and Hand Score (DASH)
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.
Measured: 2 years postoperatively
Complications and Revision Surgery
Occurrence of complications or revision procedures.
Measured: Up to 2 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Nov 2023
- Primary completion31 Dec 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Barmherzige Schwestern Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645508
- Sponsor's protocol ID
- 1264/2023
- Acronym
- STEP-AR
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional, Patient-Specific, and Augmented Reality Navigation in Reverse Total Shoulder Arthroplasty: CT-Based Glenoid Positioning Accuracy and Functional Outcomes
- ClinicalTrials.gov ID
- NCT07645508
- Acronym / sponsor ID
- STEP-AR / 1264/2023
- Conditions
- Shoulder Arthroplasty
- Keywords
- Reverse Total Shoulder Arthroplasty, Patient-Specific Instrumentation, Augmented Reality Navigation, Glenoid Positioning, CT Accuracy, Functional Outcome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Krankenhaus Barmherzige Schwestern LinzUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Major perioperative complications not related to the shoulder procedure affecting outcomes
- Incomplete imaging or clinical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Constant-Murley Score (Constant Score)
Time frame: 2 years postoperatively
American Shoulder and Elbow Surgeons (ASES)
Time frame: 2 years postoperatively
Disabilities of the Arm, Shoulder and Hand Score (DASH)
Time frame: 2 years postoperatively
Complications and Revision Surgery
Time frame: Up to 2 years postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Arthroplasty, run by Krankenhaus Barmherzige Schwestern Linz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Glenoid Component Positioning (time frame: up to 2years postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.