The Role of Patient Expectations in Traumatic Orthopedic Outcomes-TEFTOM EURASIA
The Role of Patient Expectations in Traumatic Orthopedic Outcomes TEFTOM: The Trauma Expectation Factor - Trauma Outcomes Measure TEFTOM EURASIA
Design:
Prediction trial, up to 10 sites in Asia and Europe
Goal:
To better understand the "success" or "failure" after orthopedic trauma surgery by developing a model that can be applied clinically as a user-friendly "baseline" questionnaire - capable of predicting "success" or "failure" based on a patient's pre-surgical expectations of their final outcome and to validate a novel outcomes measure (TOM).
Primary aim:
To assess the psychometric properties of predictive validity, internal consistency and reproducibility of the trauma expectation factor (TEF) in the Eurasian population.
Secondary aim:
To assess the psychometric properties of criterion validity, internal consistency,reproducibility, and sensitivity to change of the TOM in the Eurasian population.
Key questions related to patient and surgeon expectations:
- How different, or similar, are patient and surgeon expectations?
- Do expectations change over time?
- Do patient expectations predict outcomes in validated measures use today?
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Bangalore、インド、560025
- HOSMAT Hospital
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Luzern、スイス、6000
- Kantonsspital Luzern
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Zürich、スイス、8063
- Stadtspital Triemli
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Girona、スペイン、17007
- Hospital Universitari de Girona Doctor Josep Trueta
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Köln、ドイツ、50931
- Universitätsklinikum Köln
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Hong Kong、中国
- Queen Mary Hospital
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Shanghai、中国、200233
- Shanghai Sixth People's Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Isolated ankle or distal tibia fracture
Scheduled for and undergoing one of the following surgeries for their fracture:
- Open fracture and internal fixation (ORIF)
- external fixation (EF)
- EF followed by ORIF
- 18 years of age or older
- Understand and read country national language at elementary level
- Able to understand the purpose of the clinical trial,
- Able and willing to conduct all follow-up visits
- Signed informed consent
Exclusion Criteria:
- Subject has previously undergone internal fixation surgery for this ankle/distal tibia fracture.
- Subject has disease entity, or condition that precludes likelihood of bony union (e.g., metastatic cancer, metabolic bone disease).
- Subject has severe dementia or other severe mental health problem that may preclude him/her from completing study questionnaires.
- Subject is participating in other competing clinical research that may interfere with participation in this research.
- Subject is unlikely to attend study related follow-up visits.
- Subject has poly-trauma (more than one organ system compromised)
- Subject has additional fracture(s) other than ankle fracture
- Subject is a prisoner
- Fracture occurred more than 28 days before surgery
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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TEFTOM
Patient outcome measure
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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 |
時間枠 |
|---|---|
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Teftom Questionnaire
時間枠：one year
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one year
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協力者と研究者
捜査官
- 主任研究者：Reto Babst, MD、Luzerner Kantonsspital
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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。