- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01186211
Feasibility of Outpatient Total Knee Arthroplasty
연구 개요
상태
정황
상세 설명
Consecutive patients presenting for elective TKA at the General (Dr. Dervin) will be approached for enrollment.
Dr Dervin will present the study to their patients who are appropriate for the study when first confirmed for joint replacement after clinic assessment. If the patient has indicated that they are interested, the surgeon will inform the research coordinator who will then continue the consenting process. The research coordinator will confirm patient's eligibility to ensure that all inclusion and no exclusion criteria are met. The study will be explained in detail to qualify patients and they will be provided with a copy of the consent form. The consent form will also provide a clause of confidentiality informing patient privacy. All questions will be answered. Patients may also talk to the investigators with any additional questions.
Patients will be advised preoperatively about an accelerated path while in hospital that will share many attributes of the standard TOH care map,but with several additions, chosen to help reduce pain and hemarthrosis, both felt to be the major impediments to faster recuperation.
- Surgery will be performed with a muscle sparing subvastus approach, chosen because of evidenced decreased pain.
- Tranexamic acid ( 10 mg/kg) intravenously will be administered to further reduce blood loss at time of tourniquet deflation.
The "Game Ready" cold - compression device will be used post operatively to help reduce pain and minimize swelling.
.
Timeline:
Outcome data collection is expected to be completed by July 1, 2018 to allow for a minimum 6 month follow up.
Outcomes (Metrics):
The outcome measures are provided and are summarized here.
- Length of stay: We will measure LOS for these patients as compared to a cohort that is comparable in demographics who are being treated concurrently on the service
- Analgesic use in hospital and at home (where pt will maintain a 28 day pain diary to record analgesics taken and quality of life recovery questions) to be captured with special interest to any opioid sparing effect
- Physiotherapy will measure the Physical parameters such as range of motion and quadriceps strength during stay and at discharge, 2 weeks , and 1 , 2 and 3 months
- Patient satisfaction questionnaire outcome: after 6 months to evaluate
Health care resource requirement
- Physiotherapy visits
- Use of mobility aids duration
- Time to return to work where applicable
Benefits to patient The benefits to the patient will be substantial by improving the pace of recovery with less physical burden and quicker achievement of goals and resumption of normal activity.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Ontario
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Ottawa, Ontario, 캐나다, H1H 8L6
- The Ottawa General 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:
- Must be candidate for Total knee arthroplasty
- Patient of Dr Dervin
- Male or Female
- Age range between 50-75yrs,
- A Subvastus approach can be used
Patients who do not meet any exclusion criteria.
Exclusion Criteria:
- Over 75 of age
- Poor health issues
- Revised surgery on same knee
- Pt with evidence of active infection
- Pt with a BMI larger than 30kg/m2
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Patients presenting for elective TKA
Patients will be advised preoperatively about an accelerated path while in hospital that will share many attributes of the standard TOH care map but with several additions, chosen to help reduce pain and hemarthrosis, both felt to be the major impediments to faster recuperation.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Pain dairy
기간: 28 days
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measuring pain location,pain intensity, quality of pain, satisfaction with pain management, report any side effects, Quality of recovery, Pain medication schedule, Cryocuff schedule for Game Ready device
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28 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Geoffrey Dervin, MD,MSc,FRCSC, OHRI / The Ottawa 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. .
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