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Three Year Outcomes After Shoulder Arthroplasty

8 de setembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

300

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • Florida
      • Atlantis, Florida, Estados Unidos, 33462
    • Iowa
      • North Liberty, Iowa, Estados Unidos, 52317
    • Kansas
      • Leawood, Kansas, Estados Unidos, 66224
    • New York
      • Carmel, New York, Estados Unidos, 10512
        • Somers Orthopaedic Surgery & Sports Medicine Group
        • Contato:
    • Tennessee
      • Columbia, Tennessee, Estados Unidos, 38401

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
American Shoulder and Elbow Surgeons (ASES) Score
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Simple Shoulder Test score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Vani Sabesan

Colaboradores

DePuy Synthes

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

1 de janeiro de 2028

Conclusão do estudo (Estimado)

1 de agosto de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

31 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de setembro de 2026

Primeira postagem (Real)

11 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • SORE3Y001
  • DPS-JMP-CS-2025-015 (Número de outro subsídio/financiamento: DePuy Synthes)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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