Arthritis Shoulder, Arthroplasty, Replacement, Shoulder, Rotator Cuff Arthropathy
Conditions
Keywords
anatomic total shoulder arthroplasty, reverse total shoulder arthroplasty, shoulder replacement, patient-reported outcomes, preoperative planning, implant selection, shoulder prosthesis
Brief summary
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.
Detailed description
Contemporary shoulder arthroplasty systems incorporate modular components, updated implant geometry, three-dimensional (3D)-printed technology, and preoperative 3D surgical planning to support patient-specific implant selection and intraoperative decision-making. Although these features are intended to improve procedural efficiency and flexibility, multicenter evidence regarding their clinical performance and associated patient outcomes remains limited. This multicenter observational cohort study will evaluate patients who underwent primary anatomic total shoulder arthroplasty (aTSA) or reverse total shoulder arthroplasty (rTSA) using a single contemporary shoulder arthroplasty platform between 2020 and 2024. The study will combine retrospective review of existing clinical data with prospective collection of missing two- or three-year patient-reported outcome measures at a single follow-up time point. No investigational treatment, study-directed procedure, or alteration to routine clinical care will occur. Existing electronic medical records, operative reports, imaging, preoperative planning files, implant information, and patient-reported outcome databases will be retrospectively reviewed. Data collected will include demographic and clinical characteristics, surgical and implant details, preoperative planning parameters, postoperative function, patient-reported outcomes, complications, readmissions, reoperations, and revisions. When two- or three-year patient-reported outcomes are not available through routine clinical follow-up, participants may be contacted to complete a one-time validated questionnaire by telephone or secure electronic survey. The primary analysis will evaluate whether three-year outcomes after aTSA are non-inferior to those after rTSA using the American Shoulder and Elbow Surgeons score and a prespecified non-inferiority margin of 9 points. Additional analyses will compare functional outcomes, complications, and revision rates between the two procedure groups. Among patients with available preoperative 3D planning data, the study will also evaluate agreement between the planned and implanted glenoid and humeral components. Investigators will characterize the frequency and types of intraoperative deviations from the surgical plan and assess whether these deviations are associated with postoperative outcomes, complications, patient satisfaction, or revision surgery. The target sample size is up to 300 participants, with approximately 150 participants in each procedure group.
Interventions
None listed
Sponsors
Vani Sabesan
DePuy Synthes
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary shoulder arthroplasty * Age \>18 years at the time of surgery * At least 2 years from the date of surgery
Exclusion criteria
* Revision shoulder arthroplasty * Acute fracture cases * Inability to obtain consent for outcome collection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons (ASES) Score | Three Years Postoperatively | 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. |
| ASES Score | One Year, Two Years Postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Simple Shoulder Test score | One Year, Two Years, and Three Years Postoperatively | 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. |
| Single Assessment Numeric Evaluation score | One Year, Two Years, Three Years Postoperatively | Participants rate their shoulder function as a percentage of normal from 0 to 100, with higher scores indicating better perceived shoulder function. |
| Constant-Murley score | One Year, Two Years, Three Years Postoperatively | 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. |
| PENN Shoulder Score | One Year, Two Years, Three Years Postoperatively | The Penn Shoulder Score evaluates shoulder pain, satisfaction, and function. Scores range from 0 to 100, with higher scores indicating better outcomes. |
| University of California Los Angeles Shoulder Score | One Year, Two Years, Three Years Postoperatively | The UCLA Shoulder Score evaluates pain, function, active forward flexion, strength, and patient satisfaction. Scores range from 0 to 35, with higher scores indicating better outcomes. |
| Shoulder Pain and Disability Index | One Year, Two Years, Three Years Postoperatively | The SPADI evaluates shoulder pain and disability. Scores range from 0 to 100, with higher scores indicating greater pain and disability. |
| Disabilities of the Arm, Shoulder and Hand Score | One Year, Two Years, Three Years Postoperatively | The DASH evaluates symptoms and difficulty performing upper-extremity activities. Scores range from 0 to 100, with higher scores indicating greater disability. |
| Western Ontario Osteoarthritis of the Shoulder Index | One Year, Two Years, Three Years Postoperatively | The WOOS evaluates shoulder-related physical symptoms, sports and recreation, work, and emotional function. Scores will be converted to a percentage from 0 to 100, with higher normalized scores indicating better shoulder-related quality of life. |
| Short Form-12 Outcome Score | One Year, Two Years, Three Years Postoperatively | The SF-12 evaluates general health-related quality of life and produces physical and mental component summary scores. Higher scores indicate better health-related quality of life. |
| Shoulder Range of Motion | One, Two, Three Years Postoperatively | Shoulder forward flexion, abduction, external rotation, and internal rotation will be obtained from available clinical records. Forward flexion, abduction, and external rotation will be measured in degrees, and each motion will be analyzed separately. |
| Postoperative Complications | From date of surgery to time of data abstraction | The number and percentage of participants experiencing postoperative complications, including infection, dislocation or instability, scapular notching, acromial stress fracture, implant failure, or rotator cuff failure, will be assessed through review of existing clinical records. |
| Revision Shoulder Surgery | From date of surgery through time of study completion, an average of three years | The number and percentage of participants undergoing revision shoulder arthroplasty or another reoperation involving the operative shoulder will be assessed through review of existing clinical records. |
| Concordance between planned and implanted components | Date of Index Surgery | Among participants with available preoperative three-dimensional planning data, the proportion of cases in which the planned glenoid and humeral component characteristics match the components implanted during surgery will be determined. The number and percentage of cases with one or more deviations from the preoperative surgical plan will be assessed. |
Countries
United States
Contacts
CONTACTVani J Sabesan, MD
Outcome results
None listed