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?
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Köln, 독일, 50931
- Universitätsklinikum Köln
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Luzern, 스위스, 6000
- Kantonsspital Luzern
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Zürich, 스위스, 8063
- Stadtspital Triemli
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Girona, 스페인, 17007
- Hospital Universitari de Girona Doctor Josep Trueta
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Bangalore, 인도, 560025
- HOSMAT Hospital
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Hong Kong, 중국
- Queen Mary Hospital
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Shanghai, 중국, 200233
- Shanghai Sixth People's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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TEFTOM
Patient outcome measure
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Teftom Questionnaire
기간: one year
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one year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Reto Babst, MD, Luzerner Kantonsspital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .