Comparison of Conventional, Patient-Specific, and Augmented Reality Navigation in Reverse Total Shoulder Arthroplasty (STEP-AR)
Comparison of Conventional, Patient-Specific, and Augmented Reality Navigation in Reverse Total Shoulder Arthroplasty: CT-Based Glenoid Positioning Accuracy and Functional Outcomes
調査の概要
状態
条件
詳細な説明
This study investigates the accuracy and clinical relevance of different planning and implementation techniques in reverse total shoulder arthroplasty. Patients treated at a single orthopedic center between 2021 and 2024 were included. Three established surgical approaches were analyzed: conventional instrumentation, patient-specific instrumentation, and augmented reality navigation.
Initial data collection included retrospective and prospective assessment of preoperative planning parameters and their intraoperative implementation. Postoperative evaluation included low-dose CT imaging to assess glenoid component positioning accuracy.
The current phase of the study focuses on long-term clinical outcomes, with a standardized 2-year follow-up including clinical examination and validated functional outcome scores. No additional imaging is performed as part of the follow-up phase.
Patients were not randomized; group allocation reflects the surgical technique used at the time of treatment.
研究の種類
入学 (推定)
連絡先と場所
研究場所
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-
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Linz、オーストリア、4020
- Ordensklinikum Linz - Barmherzige Schwestern
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-
参加基準
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Age ≥ 18 years
- Reverse total shoulder arthroplasty performed between 2021 and 2024
- Available preoperative imaging and planning (X-ray and/or CT)
- Available postoperative CT imaging
- Written informed consent
Exclusion Criteria:
- Major perioperative complications not related to the shoulder procedure affecting outcomes
- Incomplete imaging or clinical data
研究計画
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 |
|---|
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Conventional Instrumentation
Patients who underwent reverse total shoulder arthroplasty using conventional surgical techniques.
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Patient-Specific Instrumentation
Patients who underwent reverse total shoulder arthroplasty using patient-specific instrumentation based on preoperative planning.
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Augmented Reality Navigation
Patients who underwent reverse total shoulder arthroplasty using augmented reality-assisted navigation (NEXTAR system).
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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 |
|---|---|---|
|
Accuracy of Glenoid Component Positioning
時間枠：up to 2years postoperatively
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Comparison of preoperative planning parameters with postoperative CT-based measurements of glenoid component positioning, including inclination, version, implant size, and screw placement.
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up to 2years postoperatively
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Constant-Murley Score (Constant Score)
時間枠：2 years postoperatively
|
The Constant Score is a comprehensive shoulder function assessment.
The total score ranges from 0 to 100 points.
Higher scores indicate better shoulder performance and function; lower scores indicate greater functional impairment and symptoms.
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2 years postoperatively
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American Shoulder and Elbow Surgeons (ASES)
時間枠：2 years postoperatively
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Shoulder pain and function will be assessed using the American Shoulder and Elbow Surgeons Score.
The total score ranges from 0 to 100 points.
Higher scores indicate less pain and better shoulder function.
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2 years postoperatively
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Disabilities of the Arm, Shoulder and Hand Score (DASH)
時間枠：2 years postoperatively
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The Disabilities of the Arm, Shoulder and Hand Score measures disability and symptoms affecting the upper extremity, including the arm, shoulder, and hand.
The total score ranges from 0 to 100 points.
Lower scores indicate better upper-limb function and fewer symptoms; higher scores indicate greater disability and functional limitations.
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2 years postoperatively
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Complications and Revision Surgery
時間枠：Up to 2 years postoperatively
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Occurrence of complications or revision procedures.
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Up to 2 years postoperatively
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 1264/2023
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。