- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01849445
Targeted Rehabilitation to Improve Outcome After Knee Replacement- A Physiotherapy Study (TRIO-Physio)
Targeted Rehabilitation to Improve Outcome After Knee Replacement- A Physiotherapy Study (TRIO-Physio)
The TRIO-physio study is looking at how well patients with osteoarthritis recover after knee replacement surgery (also known as Total Knee Arthroplasty (TKA)). Currently around 20% of patients are not satisfied after TKA. This project will look to find out if the research team can identify patients who will not recover well at an earlier stage, so that these patients can be helped sooner.
The study will try to determine if doing intense physiotherapy with patients who are not doing well at the first review (6 weeks after their operation) can improve how well they have recovered at one year.
연구 개요
상세 설명
The study is a randomised controlled trial comparing the effect of intensive physiotherapy compared to current standard of care therapy, targeted to patients performing poorly at 6 weeks following total knee replacement.
All patients will be made aware of the study pre-operatively at the recruiting centres. Prior to surgery they will complete the routine pre-operative outcome assessment questionnaires (Oxford Knee Score and EQ-5D) as part of the national PROMS program and then undergo the local standard total knee replacement and immediate post-operative care pathway.
All patients will be routinely reviewed 6 weeks post-operatively by the usual clinical teams. At this review the Oxford Knee Score will again be assessed. Those patients who report a score of 26 or less (on the 0-48 OKS scoring system), which is defined as poor by the Kalairajah classification (Kalairajah, 2005), will be approached to consent. If consent is given and the patient is eligible to enter the trial, randomisation into one of the following groups will occur: to standard care (encompassing a one off physiotherapy review, 6 weeks of home exercise prescription and final review) or to an interventional arm, where 18 sessions of structured physiotherapy will be administered over a 6 week period, where 6 of these sessions will be 'contact sessions' performed under the supervision of the physiotherapist.
All trial participants will be reviewed immediately post intervention (i.e. at 14 weeks post operation) and then by postal questionnaire at 26 and 52 weeks post-operation.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Aberdeen, 영국, AB24 2ZN
- NHS Grampian
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Doncaster, 영국
- Doncaster Royal Infirmary
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Edinburgh, 영국, EH16 4SA
- NHS Lothian
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Oxford, 영국, OX3 7HE
- Oxford University Hospitals NHS Trust
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Portsmouth, 영국, PO3 6AD
- Kim Brown
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Weston Super Mare, 영국
- Weston Super Mare
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Undergoing primary total knee arthroplasty for osteoarthritis.
- Defined poor outcome (Oxford Knee Score less than or equal to 26) at first post-op review (6 weeks).
- Patients are able to consent and willing to comply with the study protocol
Exclusion Criteria:
- Patients undergoing revision knee arthroplasty or fully constrained knee arthroplasty
- Knee replacement for a diagnosis other than osteoarthritis
- Patients unable to attend the study physiotherapy intervention centre
- Procedures done purely for pain relief (such as for patients with no walking capacity)
- Patients already receiving ongoing structured post-operative exercise rehabilitation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Intensive physiotherapy
Participants will visit hospital for physiotherapy sessions once a week for 6 weeks in addition to completing prescribed exercises twice a week at home on their own.
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Participants will visit hospital for physiotherapy sessions once a week for 6 weeks in addition to completing prescribed exercises twice a week at home on their own.
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활성 비교기: Home physiotherapy excercises
Patients will be asked to complete prescribed exercises at home on their own 3 times a week for 6 weeks.
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Patients will be asked to complete prescribed exercises at home on their own 3 times a week for 6 weeks.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Oxford Knee Score
기간: 52 weeks post-operation
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Primary analysis will be 52 week outcome (Oxford Knee Score) in the enhanced physiotherapy intervention group compared to the current standard of care physiotherapy treatment group.
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52 weeks post-operation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Patient satisfaction
기간: 52 weeks post-operation
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Assess patient satisfaction with knee arthroplasty. Assessed with a specific patient satisfaction question: Are you satisfied with your knee replacement? (Possible responses: very satisfied, satisfied, dissatisfied, very dissatisfied) Specific satisfaction with pain relief and functional ability will also be assessed. 4 additional sub-questions relating to facets of satisfaction:
(Possible answers: excellently, very well, well, fairly, poorly) |
52 weeks post-operation
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Knee function
기간: week 8 and week 14
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Assess the actual physical function of the patient as a result of the differing physiotherapy interventions.
Timed-get-up-and-go-test, assessed prior to (8-weeks post op) and following 6 week physiotherapy protocol (14 weeks post-op).
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week 8 and week 14
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Cost effectiveness
기간: 52 weeks post
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To evaluate the cost effectiveness of enhanced targeted physiotherapy.
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52 weeks post
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공동 작업자 및 조사자
수사관
- 수석 연구원: Hamish Simpson, University of Edinburgh
간행물 및 유용한 링크
일반 간행물
- Hamilton DF, Beard DJ, Barker KL, Macfarlane GJ, Tuck CE, Stoddart A, Wilton T, Hutchinson JD, Murray GD, Simpson AHRW; TRIO investigators. Targeting rehabilitation to improve outcomes after total knee arthroplasty in patients at risk of poor outcomes: randomised controlled trial. BMJ. 2020 Oct 13;371:m3576. doi: 10.1136/bmj.m3576.
- Simpson AH, Hamilton DF, Beard DJ, Barker KL, Wilton T, Hutchison JD, Tuck C, Stoddard A, Macfarlane GJ, Murray GD. Targeted rehabilitation to improve outcome after total knee replacement (TRIO): study protocol for a randomised controlled trial. Trials. 2014 Feb 1;15:44. doi: 10.1186/1745-6215-15-44.
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. .
무릎 골관절염에 대한 임상 시험
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University Hospital Inselspital, BerneDeka Medical, Inc.모집하지 않고 적극적으로
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Catherine Vandepitte, M.D.Pacira Pharmaceuticals, Inc완전한
Intensive physiotherapy에 대한 임상 시험
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Centre Hospitalier Universitaire de Saint Etienne종료됨