- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02982785
Knee Replacement Outcome Predicted by Physiotherapists
Knee Replacement Outcome Predicted by Physiotherapists: A Prospective Cohort
The aim is to assess if physiotherapists attending inpatients at elective orthopaedic wards can predict the future course (post hospitalisation) of recovery of patients undergoing KA. The prediction is made at hospital discharge using a 1-10 numerical rating scale (1=poor prognosis; 10=best prognosis).
To identify candidate prognostic factors, the therapist are asked to qualify their prognosis narratively, by listing at least 3-5 factors that they consider important for their projected prognosis score. There will be no maximum number of factors the physiotherapist can list.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Copenhagen, 덴마크, 2400
- Bispebjerg Hospital, Department of Physical and Occupational Therapy
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Copenhagen, 덴마크, 2900
- Gentofte Hospital, Department of Physical Therapy
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients undergoing primary total knee arthroplasty (TKA) for treatment of knee osteoarthritis. All patients from december 2016 to december 2017 will be invited to participate.
If it is not possible to reach the set sample size within the set timeframe, recruitment will continue until the numbers specified in the a priori sample size calculation are reached. Should the set sample size be reached ahead of time, recruitment will stop.
설명
Inclusion Criteria:
- Received primary knee replacement surgery for knee OA
- Age ≥ 18 years
- Reads and speaks Danish
- Has an email address
- Signed informed consent
Exclusion Criteria:
- Cognitive impairments that preclude reliable answers to online questionnaires (e.g. dementia)
- Revision surgery
공부 계획
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디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Oxford Knee Score
기간: 6 months after surgery
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6 months after surgery
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Oxford Knee Score
기간: 12 months after surgery
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12 months after surgery
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Patient Acceptable Symptom State
기간: 6 and 12 months after surgery
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6 and 12 months after surgery
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EuroQoL questionnaire
기간: 6 and 12 months after surgery
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6 and 12 months after surgery
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Questionnaire regarding postoperative rehabilitation
기간: 6 and 12 months after surgery
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This is a questionnaire that includes questions regarding the postoperative rehabilitation (i.e., setting, participation, type, duration, frequency, and degree of supervision).
Details from post-operative rehabilitation provided at one of the investigational sites will be obtained from the patients' hospital records
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6 and 12 months after surgery
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Transition ratings of global perceived effect
기간: 6 and 12 months after surgery
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This is a transition questionnaire on which the participants initially answers if their current state is "unchanged, worse" or "better" compared to pre-surgery.
An "unchanged" equals a transition score of 0. If the participant answers "worse", the participant is asked to rate the degree of worsening on a 7 point Likert scale, and the corresponding scores range from -1 to -7.
Correspondingly, if a participant answers "better", the participant is asked to rate the degree of improvement on a 7 point Likert scale, and the corresponding scores range from 1 to 7. Thus the global perceived effect score range from -7 (worsening) to 7 (improvement), with the mid-point - 0 - representing no change.
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6 and 12 months after surgery
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Adverse events
기간: 6 and 12 months after surgery
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Survey of the participants for events that patients have experienced during the observation period.
These events will be self-reported using a questionnaire with ample space for free text.
An event will be defined as causing limitations in daily activities, Sports/Recreational activities or work limitations together with symptoms causing participants to seek medical care.
The events may be unrelated to the knee (such as development or exacerbation of comorbidities) and the events are not necessarily causally linked to the knee surgery
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6 and 12 months after surgery
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Marius Henriksen, PT, PhD, Department of Physical and Occupational Therapy, Bispebjerg-Frederiksberg Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 (실제)
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. .