- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07651215
Radiographic and Clinical Outcomes After Short-Stem Reverse Shoulder Arthroplasty (STEP2yrs)
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.
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.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Linz, Austria, 3340
- Ordensklinikum Linz - Barmherzige Schwester
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria:
- Reverse shoulder arthroplasty with short humeral stem
- Surgery performed at Ordensklinikum Linz
- Minimum postoperative follow-up of 2 years
- Written informed consent
Exclusion Criteria:
- Perioperative complications not related to the surgical procedure
- Lack of consent for study participation
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Radiographic Changes of the Humeral Component
Time Frame: ≥2 years postoperatively
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Assessment of humeral-sided radiographic changes including: Stress shielding Radiolucent lines Osteolysis Periprosthetic fractures Measured using standardized radiographs at follow-up. |
≥2 years postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Constant-Murley Score (Constant Score)
Time Frame: up to 3 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.
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up to 3 years postoperatively
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American Shoulder and Elbow Surgeons Score (ASES)
Time Frame: up to 3 years postoperatively
|
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.
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up to 3 years postoperatively
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Simple Shoulder Test Score (SST)
Time Frame: up to 3 Years Postoperatively
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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.
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up to 3 Years Postoperatively
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Return to Sport Rate (RTS)
Time Frame: up to 3 years postoperatively
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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.
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up to 3 years postoperatively
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1035/2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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