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NCT Number: NCT07815535

Three Year Outcomes After Shoulder Arthroplasty

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.

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Key information

Conditions

Arthroplasty, Replacement, Shoulder Arthritis Shoulder Rotator Cuff Arthropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sabesan Orthopaedics Research Inc, Atlantis, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. American Shoulder and Elbow Surgeons (ASES) Score

    Time frame: 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.

  2. ASES Score

    Time frame: 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 outcomes

  1. Simple Shoulder Test score

    Time frame: 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.

  2. Single Assessment Numeric Evaluation score

    Time frame: 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.

  3. Constant-Murley score

    Time frame: 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.

  4. PENN Shoulder Score

    Time frame: 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.

  5. University of California Los Angeles Shoulder Score

    Time frame: 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.

  6. Shoulder Pain and Disability Index

    Time frame: 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.

  7. Disabilities of the Arm, Shoulder and Hand Score

    Time frame: 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.

  8. Western Ontario Osteoarthritis of the Shoulder Index

    Time frame: 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.

  9. Short Form-12 Outcome Score

    Time frame: 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.

  10. Shoulder Range of Motion

    Time frame: 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.

  11. Postoperative Complications

    Time frame: 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.

  12. Revision Shoulder Surgery

    Time frame: 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.

  13. Concordance between planned and implanted components

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Vani J Sabesan, MD

CONTACT

[email protected]

754-233-3658

Sponsors and collaborators

Lead sponsor

Vani Sabesan

Other

Collaborators

  • DePuy Synthes

Registry information

Official study title

Evaluating Three-Year Outcomes For Total Versus Reverse Shoulder Arthroplasty

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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