Three Year Outcomes After Shoulder Arthroplasty
Part of paid clinical trials in Atlantis, Florida.
- Sponsor
- Vani Sabesan
- Study ID
- NCT07815535
- Status
- Not Yet Recruiting
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Conditions
- Arthritis Shoulder
- Arthroplasty, Replacement, Shoulder
- Rotator Cuff Arthropathy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- First listed
- Sep 11, 2026
- Start date
- Sep 30, 2026
- Status verified
- Sep 2026
- Primary completion
- Jan 31, 2028
- Completion
- Aug 31, 2028
Study Design
- Enrollment
- 300 participants (estimated)
Arms
- Arm: Anatomic Total Shoulder ArthroplastyPatients who underwent primary anatomic total shoulder arthroplasty using the study implant platform between 2020 and 2024.
- Arm: Reverse Total Shoulder ArthroplastyPatients who underwent primary reverse total shoulder arthroplasty using the study implant platform between 2020 and 2024.
Primary Outcome Measure
American Shoulder and Elbow Surgeons (ASES) Score [ Time Frame: Three Years Postoperatively ]
Central Contacts
- Vani J Sabesan, MD754-233-3658
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Sabesan Orthopaedics Research Inc | Atlantis | Florida | 33462 | |
| Steindler Orthopaedic Clinic | North Liberty | Iowa | 52317 | |
| Kansas City Orthopaedic Alliance | Leawood | Kansas | 66224 | |
| Somers Orthopaedic Surgery & Sports Medicine Group | Carmel | New York | 10512 | |
| Tennessee Orthopaedic Alliance | Columbia | Tennessee | 38401 |
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