Three Year Outcomes After Shoulder Arthroplasty
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVani Sabesan
About this trial
The purpose of this multicenter observational cohort study is to evaluate three-year outcomes in adults who underwent anatomic or reverse total shoulder arthroplasty using a contemporary shoulder implant system. The main questions it aims to answer are:
Are three-year patient-reported outcomes after anatomic total shoulder arthroplasty comparable to those after reverse total shoulder arthroplasty? How often do the implants used during surgery differ from the preoperative three-dimensional (3D) surgical plan, and are these differences associated with patient outcomes, complications, or revision surgery?
Researchers will compare patient-reported outcomes, function, complications, and revision rates between patients who underwent anatomic and reverse total shoulder arthroplasty.
Researchers will review participant existing medical records and surgical information. Participants whose two- or three-year outcome measures are not available may be asked to complete a one-time questionnaire by telephone or secure electronic survey. No treatments or additional clinical procedures will be performed as part of this study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Primary shoulder arthroplasty
Age >18 years at the time of surgery
At least 2 years from the date of surgery
Disqualifiers
Revision shoulder arthroplasty
Acute fracture cases
Inability to obtain consent for outcome collection
Trial population
Eligible patients will be identified from a cohort of individuals who underwent either a total or reverse shoulder arthroplasty from 2020-2024 using a single innovative implant system, with a target enrollment of 300 patients. The cohort will include patients from participating sites and the data collected will be deidentified.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 2 trial groupsGroup A: Anatomic Total Shoulder Arthroplasty
Group B: Reverse Total Shoulder Arthroplasty
Trial outcomes
Primary outcomes
1
American Shoulder and Elbow Surgeons (ASES) Score
The ASES score is a patient-reported measure of shoulder pain and function scored from 0 to 100, with higher scores indicating better outcomes. Three-year ASES scores will be compared between patients who underwent anatomic and reverse total shoulder arthroplasty.
Time frame
Three Years Postoperatively2
ASES Score
The ASES score is a patient-reported measure of shoulder pain and function scored from 0 to 100, with higher scores indicating better outcomes. Three-year ASES scores will be compared between patients who underwent anatomic and reverse total shoulder arthroplasty.
Time frame
One Year, Two Years PostoperativelySecondary outcomes
1
Simple Shoulder Test score
The Simple Shoulder Test is a 12-item patient-reported assessment of shoulder function. Scores range from 0 to 12, with higher scores indicating better shoulder function.
Time frame
One Year, Two Years, and Three Years Postoperatively2
Single Assessment Numeric Evaluation score
Participants rate their shoulder function as a percentage of normal from 0 to 100, with higher scores indicating better perceived shoulder function.
Time frame
One Year, Two Years, Three Years Postoperatively3
Constant-Murley score
The Constant-Murley score evaluates shoulder pain, activities of daily living, range of motion, and strength. Scores range from 0 to 100, with higher scores indicating better shoulder function.
Time frame
One Year, Two Years, Three Years Postoperatively4
PENN Shoulder Score
The Penn Shoulder Score evaluates shoulder pain, satisfaction, and function. Scores range from 0 to 100, with higher scores indicating better outcomes.
Time frame
One Year, Two Years, Three Years PostoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Vani Sabesan
Lead sponsor
Sabesan Orthopaedics Research Inc
Sponsor institution
DePuy Synthes
Collaborator
Source ClinicalTrials.gov
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