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Three Year Outcomes After Shoulder Arthroplasty

8 września 2026 zaktualizowane przez: Vani Sabesan

Evaluating Three-Year Outcomes For Total Versus Reverse 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

300

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Stany Zjednoczone
    • Florida
      • Atlantis, Florida, Stany Zjednoczone, 33462
    • Iowa
      • North Liberty, Iowa, Stany Zjednoczone, 52317
    • Kansas
      • Leawood, Kansas, Stany Zjednoczone, 66224
    • New York
      • Carmel, New York, Stany Zjednoczone, 10512
    • Tennessee
      • Columbia, Tennessee, Stany Zjednoczone, 38401

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Anatomic Total Shoulder Arthroplasty
Patients who underwent primary anatomic total shoulder arthroplasty using the study implant platform between 2020 and 2024.
Reverse Total Shoulder Arthroplasty
Patients who underwent primary reverse total shoulder arthroplasty using the study implant platform between 2020 and 2024.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
American Shoulder and Elbow Surgeons (ASES) Score
Ramy czasowe: 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.
Three Years Postoperatively
ASES Score
Ramy czasowe: 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.
One Year, Two Years Postoperatively

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Simple Shoulder Test score
Ramy czasowe: 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.
One Year, Two Years, and Three Years Postoperatively
Single Assessment Numeric Evaluation score
Ramy czasowe: 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.
One Year, Two Years, Three Years Postoperatively
Constant-Murley score
Ramy czasowe: 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.
One Year, Two Years, Three Years Postoperatively
PENN Shoulder Score
Ramy czasowe: 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.
One Year, Two Years, Three Years Postoperatively
University of California Los Angeles Shoulder Score
Ramy czasowe: 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.
One Year, Two Years, Three Years Postoperatively
Shoulder Pain and Disability Index
Ramy czasowe: 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.
One Year, Two Years, Three Years Postoperatively
Disabilities of the Arm, Shoulder and Hand Score
Ramy czasowe: 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.
One Year, Two Years, Three Years Postoperatively
Western Ontario Osteoarthritis of the Shoulder Index
Ramy czasowe: 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.
One Year, Two Years, Three Years Postoperatively
Short Form-12 Outcome Score
Ramy czasowe: 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.
One Year, Two Years, Three Years Postoperatively
Shoulder Range of Motion
Ramy czasowe: 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.
One, Two, Three Years Postoperatively
Postoperative Complications
Ramy czasowe: 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.
From date of surgery to time of data abstraction
Revision Shoulder Surgery
Ramy czasowe: 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.
From date of surgery through time of study completion, an average of three years
Concordance between planned and implanted components
Ramy czasowe: 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.
Date of Index Surgery

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Vani Sabesan

Współpracownicy

DePuy Synthes

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 stycznia 2028

Ukończenie studiów (Szacowany)

1 sierpnia 2028

Daty rejestracji na studia

Pierwszy przesłany

31 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 września 2026

Pierwszy wysłany (Rzeczywisty)

11 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

11 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • SORE3Y001
  • DPS-JMP-CS-2025-015 (Inny numer grantu/finansowania: DePuy Synthes)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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