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 Arthroplasty
    Patients who underwent primary anatomic total shoulder arthroplasty using the study implant platform between 2020 and 2024.
  • Arm: Reverse Total Shoulder Arthroplasty
    Patients 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

Locations (5)

FacilityCityStateZIPSite coordinators
Sabesan Orthopaedics Research IncAtlantisFlorida33462
Vani Sabesan, MD
754-233-3658
Steindler Orthopaedic ClinicNorth LibertyIowa52317
Vani Sabesan, MD
754-233-3658
Kansas City Orthopaedic AllianceLeawoodKansas66224
Vani Sabesan, MD
754-233-3658
Somers Orthopaedic Surgery & Sports Medicine GroupCarmelNew York10512
Vani Sabesan, MD
754-233-3658
Tennessee Orthopaedic AllianceColumbiaTennessee38401
Vani Sabesan, MD
754-233-3658

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