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Three Year Outcomes After Shoulder Arthroplasty

2026年9月8日更新者：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.

調査の概要

状態

まだ募集していません

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

300

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

名前：Vani J Sabesan, MD
電話番号：754-233-3658
メール：sabes001@gmail.com

研究場所

アメリカ
- Florida
  - Atlantis、Florida、アメリカ、33462
    - Sabesan Orthopaedics Research Inc
    - コンタクト：
      
      Vani Sabesan, MD
      
      電話番号：754-233-3658
      
      メール：sabesanorthoresearch@gmail.com
- Iowa
  - North Liberty、Iowa、アメリカ、52317
    - Steindler Orthopaedic Clinic
    - コンタクト：
      
      Vani Sabesan, MD
      
      電話番号：754-233-3658
      
      メール：sabesanorthoresearch@gmail.com
- Kansas
  - Leawood、Kansas、アメリカ、66224
    - Kansas City Orthopaedic Alliance
    - コンタクト：
      
      Vani Sabesan, MD
      
      電話番号：754-233-3658
      
      メール：sabesanorthoresearch@gmail.com
- New York
  - Carmel、New York、アメリカ、10512
    - Somers Orthopaedic Surgery & Sports Medicine Group
    - コンタクト：
      
      Vani Sabesan, MD
      
      電話番号：754-233-3658
      
      メール：sabesanorthoresearch@gmail.com
- Tennessee
  - Columbia、Tennessee、アメリカ、38401
    - Tennessee Orthopaedic Alliance
    - コンタクト：
      
      Vani Sabesan, MD
      
      電話番号：754-233-3658
      
      メール：sabesanorthoresearch@gmail.com

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

大人
高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホートグループ/コホート生物医学的または健康上の結果について評価される観察研究の参加者のグループまたはサブグループ。
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
American Shoulder and Elbow Surgeons (ASES) Score 時間枠：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 時間枠：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

二次結果の測定

結果測定	メジャーの説明	時間枠
Simple Shoulder Test score 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Vani Sabesan

協力者

DePuy Synthes

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2028年1月1日

研究の完了 (推定)

2028年8月1日

試験登録日

最初に提出

2026年8月31日

QC基準を満たした最初の提出物

2026年9月8日

最初の投稿 (実際)

2026年9月11日

学習記録の更新

投稿された最後の更新 (実際)