Shoulder ArthroplastySTEP2yrsNCT07651215
Radiographic and Clinical Outcomes After Short-Stem Reverse Shoulder Arthroplasty
An observational study of Shoulder Arthroplasty and Shoulder Joint Disease, run by Krankenhaus Barmherzige Schwestern Linz at 1 site in Austria.
Trial summary
Reverse total shoulder arthroplasty (RTSA) has become increasingly common in recent years due to expanding indications and improved surgical techniques. Short-stem humeral implants have gained attention because they preserve bone stock, allow metaphyseal fixation, and facilitate potential revision procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Arthroplasty, Shoulder Joint Disease, Reverse Shoulder Prosthesis
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2026to 31 Dec 2026
- How long will I take part?
- 2 Years
- 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: The study population consists of adult patients who underwent reverse total shoulder arthroplasty with a short humeral stem at the Department of Orthopedics, Ordensklinikum Linz, Austria. All eligible patients who received this procedure at least two years prior to enrollment will be invited for a clinical and radiographic follow-up examination. Participants are identified through institutional medical records and include both male and female patients. Only patients who provide written informed consent will be included in the study.
Who may be able to join
- Reverse shoulder arthroplasty with short humeral stem
- Surgery performed at Ordensklinikum Linz
- Minimum postoperative follow-up of 2 years
- Written informed consent
Who cannot join
- Perioperative complications not related to the surgical procedure
- Lack of consent for study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Humeral-Sided Radiographic Changes and Clinical Outcome After Reverse Total Shoulder Arthroplasty With Short Stem - Minimum 2-Year Follow-Up
Reverse total shoulder arthroplasty (RTSA) has become increasingly common in recent years due to expanding indications and improved surgical techniques. Short-stem humeral implants have gained attention because they preserve bone stock, allow metaphyseal fixation, and facilitate potential revision procedures.
The aim of this study is to evaluate radiographic and clinical outcomes following reverse shoulder arthroplasty with a short humeral stem after a minimum follow-up of two years. Patients who underwent RTSA at the Department of Orthopedics at Ordensklinikum Linz will be invited for clinical and radiographic follow-up.
Read more
Clinical outcomes will be assessed using established shoulder scores including the Constant Score, the American Shoulder and Elbow Surgeons (ASES) score, and the Simple Shoulder Test (SST). Radiographic evaluation will focus on humeral-sided changes such as stress shielding, radiolucent lines, osteolysis, and fractures. Patient satisfaction will additionally be assessed using visual analogue scales and patient-reported outcome measures.
Demographic variables, comorbidities, and implant-related characteristics will be collected to allow descriptive evaluation of factors potentially associated with clinical and radiographic outcomes.
Read the detailed description
Retrospective with prospective follow-up
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Changes of the Humeral Component
Assessment of humeral-sided radiographic changes including:
Stress shielding Radiolucent lines Osteolysis Periprosthetic fractures
Measured using standardized radiographs at follow-up.
Measured: ≥2 years 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: up to 3 years postoperatively
American Shoulder and Elbow Surgeons Score (ASES)
The American Shoulder and Elbow Surgeons Score is used to assess shoulder pain and function. The total score ranges from 0 to 100 points. Higher scores indicate better shoulder function, less pain, and fewer activity limitations; lower scores indicate greater pain, impaired shoulder function, and increased disability.
Measured: up to 3 years postoperatively
Simple Shoulder Test Score (SST)
Shoulder function will be assessed using the Simple Shoulder Test. The total score ranges from 0 to 12 points. Higher scores indicate better shoulder function.
Measured: up to 3 Years Postoperatively
Return to Sport Rate (RTS)
Return to sport will be assessed as the proportion or percentage of patients who returned to sport participation after surgery. Higher percentages indicate a better outcome, reflecting a greater rate of successful return to sport.
Measured: up to 3 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 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)
- Target duration
- 2 Years
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
- NCT07651215
- Sponsor's protocol ID
- 1035/2026
- Acronym
- STEP2yrs
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humeral-Sided Radiographic Changes and Clinical Outcome After Reverse Total Shoulder Arthroplasty With Short Stem - Minimum 2-Year Follow-Up
- ClinicalTrials.gov ID
- NCT07651215
- Acronym / sponsor ID
- STEP2yrs / 1035/2026
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Krankenhaus Barmherzige Schwestern LinzUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 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.
Reverse total shoulder arthroplasty (RTSA) has become increasingly common in recent years due to expanding indications and improved surgical techniques. Short-stem humeral implants have gained attention because they preserve bone stock, allow metaphyseal fixation, and facilitate potential revision procedures.
The aim of this study is to evaluate radiographic and clinical outcomes following reverse shoulder arthroplasty with a short humeral stem after a minimum follow-up of two years. Patients who underwent RTSA at the Department of Orthopedics at Ordensklinikum Linz will be invited for clinical and radiographic follow-up.
Clinical outcomes will be assessed using established shoulder scores including the Constant Score, the American Shoulder and Elbow Surgeons (ASES) score, and the Simple Shoulder Test (SST). Radiographic evaluation will focus on humeral-sided changes such as stress shielding, radiolucent lines, osteolysis, and fractures. Patient satisfaction will additionally be assessed using visual analogue scales and patient-reported outcome measures.
Demographic variables, comorbidities, and implant-related characteristics will be collected to allow descriptive evaluation of factors potentially associated with clinical and radiographic outcomes.
Detailed description
Retrospective with prospective follow-up
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients who underwent reverse total shoulder arthroplasty with a short humeral stem at the Department of Orthopedics, Ordensklinikum Linz, Austria. All eligible patients who received this procedure at least two years prior to enrollment will be invited for a clinical and radiographic follow-up examination. Participants are identified through institutional medical records and include both male and female patients. Only patients who provide written informed consent will be included in the study.
Key inclusion criteria (4 listed)
- Reverse shoulder arthroplasty with short humeral stem
- Surgery performed at Ordensklinikum Linz
- Minimum postoperative follow-up of 2 years
- Written informed consent
Key exclusion criteria (2 listed)
- Perioperative complications not related to the surgical procedure
- Lack of consent for study participation
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
Radiographic Changes of the Humeral Component
Time frame: ≥2 years postoperatively
Assessment of humeral-sided radiographic changes including: Stress shielding Radiolucent lines Osteolysis Periprosthetic fractures Measured using standardized radiographs at follow-up.
4 secondary outcomes
Constant-Murley Score (Constant Score)
Time frame: up to 3 years postoperatively
American Shoulder and Elbow Surgeons Score (ASES)
Time frame: up to 3 years postoperatively
Simple Shoulder Test Score (SST)
Time frame: up to 3 Years Postoperatively
Return to Sport Rate (RTS)
Time frame: up to 3 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 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 and Shoulder Joint Disease, 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 4 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: enrolling by invitation, as of the sponsor's last update on 16 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?
Radiographic Changes of the Humeral Component (time frame: ≥2 years 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 16 Jun 2026.