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Three Year Outcomes After Shoulder Arthroplasty

8 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

300

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Florida
      • Atlantis, Florida, États-Unis, 33462
    • Iowa
      • North Liberty, Iowa, États-Unis, 52317
    • Kansas
      • Leawood, Kansas, États-Unis, 66224
    • New York
      • Carmel, New York, États-Unis, 10512
        • Somers Orthopaedic Surgery & Sports Medicine Group
        • Contact:
    • Tennessee
      • Columbia, Tennessee, États-Unis, 38401

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
American Shoulder and Elbow Surgeons (ASES) Score
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Simple Shoulder Test score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Vani Sabesan

Collaborateurs

DePuy Synthes

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 janvier 2028

Achèvement de l'étude (Estimé)

1 août 2028

Dates d'inscription aux études

Première soumission

31 août 2026

Première soumission répondant aux critères de contrôle qualité

8 septembre 2026

Première publication (Réel)

11 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • SORE3Y001
  • DPS-JMP-CS-2025-015 (Autre subvention/numéro de financement: DePuy Synthes)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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