- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01832272
Reinflation After Early Tourniquet Release in Total Knee Arthroplasty
2014년 5월 18일 업데이트: Tae Kyun Kim, Seoul National University Hospital
The Effects of Tourniquet Reinflation After Early Tourniquet Release in Total Knee Arthroplasty
This study is aimed to determine the efficacy and the safety of the tourniquet reinflation after early tourniquet release in total knee arthroplasty, compared to the method of early deflation without reinflation.
The investigators hypothesized that the reinflation after early release of the tourniquet would be effective in terms of improved visualization of the surgical field and decreased operation time and blood loss, whereas it would increase tourniquet-related complication due to longer tourniquet-use time.
연구 개요
상세 설명
Total knee arthroplasty(TKA) is mostly performed with tourniquet applied, because it allows decreased intraoperative blood loss, better visualization of surgical field and better cement fixation of the implants, compared to the TKA without using tourniquet.
However, there remains a controversy about the timing of tourniquet release, so the tourniquet may be unreleased throughout the whole operation time or released early just after cement fixation of the implants, atc.
Early tourniquet release is generally aimed to control hidden arterial bleeding which would not be revealed if the tourniquet was unreleased.
This method was reported to reduce arterial bleeding and its related complications, but it was also known that increase intraoperative bleeding, incidence of transfusion, and operation time.
On the other hand, late tourniquet release, which the tourniquet is unreleased until the wound is closed, is reported to increase tourniquet-use time and related complications owing to longer tourniquet time, although it gives shorter operation time.
The investigators have been used a way of reinflation of tourniquet after early release, once the arterial bleeding was controlled sufficiently, to balance the advantages and disadvantages of the early tourniquet release.
The investigators were able to control arterial bleeding during the time the tourniquet was released, and the remained procedures were performed conveniently with good visualization of the surgical field after the tourniquet was reinflated again.
However, there was no previous studies about the efficacy and the safety of the way of reinflation after early release of the tourniquet in the literature.
Therefore, the investigators ask in this study whether the reinflation after early tourniquet release has advantages over the method of early tourniquet release without reinflation, in terms of efficacy and safety.
연구 유형
중재적
등록 (예상)
174
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Gyeonggi-do
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Seongnam-Si, Gyeonggi-do, 대한민국, 463-707
- 모병
- Joint Reconstruction Center, Seoul National University Bundang Hospital
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연락하다:
- Tae Kyun Kim, MD, PhD
- 전화번호: 82-31-787-7196
- 이메일: osktk@snubh.org
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
40년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Diagnosis of primary osteoarthritis of the knee
- Scheduled for elective total knee arthroplasty
- Written signed consent
Exclusion Criteria:
- Revision TKA
- Diagnosis other than primary osteoarthritis
- Intra-articular indwelling drainage
- Refusing participate
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Reinflation after early deflation
The tourniquet is released after cement implant fixation, and then reinflated, once arterial bleeding was controlled (Reinflation after early tourniquet deflation).
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The tourniquet is released after cement implant fixation, and then reinflated, once arterial bleeding was controlled
다른 이름들:
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간섭 없음: No reinflation after early deflation
The tourniquet is released after cement implant fixation, and remained deflated without reinflation, even after hemostasis.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Operation time
기간: from skin incision to wound closure
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Total time between initial skin incision and wound closure
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from skin incision to wound closure
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Tourniquet time
기간: total sum of time between inflation and deflation of tourniquet
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Total time of tourniquet-use during the operation which defined from skin incision to the wound closure
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total sum of time between inflation and deflation of tourniquet
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Difficulty of the operation
기간: from skin incision to wound closure
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Measured by the number of operative field clearance using gauze to make the remained procedure convenient
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from skin incision to wound closure
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Incidence of transfusion
기간: within 2weeks after surgery
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The incidence of allogenic or autologous (preoperative autologous blood donation) transfusion after surgery due to significant hemoglobin drop within 2weeks after surgery
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within 2weeks after surgery
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Wound complications
기간: on the 2nd and 14th day after surgery
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wound complications evaluated on the 2nd and 14th day after surgery, such as ecchymosis, subcutaneous hematoma, hemarthrosis, and oozing
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on the 2nd and 14th day after surgery
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Thigh complications
기간: within 2 weeks
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Thigh complication due to the tourniquet, such as ecchymosis, skin bullae, and skin necrosis around the area of tourniquet application
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within 2 weeks
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Venous thromboembolism
기간: within 2 weeks
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symptomatic deep vein thrombosis and pulmonary embolism, detected within 2weeks after surgery
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within 2 weeks
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Postoperative pain (VAS)
기간: on the 2nd and 5th day after surgery.
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An independent investigator who was blinded to randomization assessed knee and thigh pain level using 0 to 10 visual analog scale (VAS) that ranged from 0 (no pain) to 10 (worst imaginable pain) on the 2nd and 5th day after surgery.
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on the 2nd and 5th day after surgery.
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More painful site
기간: on the 2nd and 5th day after surgery
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An independent investigator who was blinded to randomization assessed the more painful site either knee (operation site) or thigh (tourniquet application site) on the 2nd and 5th day after surgery.
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on the 2nd and 5th day after surgery
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More painful side in SBTKA
기간: on the 2nd and 5th day after surgery.
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An independent investigator who was blinded to randomization assessed the more painful side in patients undergoing simultaneous bilateral TKA (SBTKA), whose each knee will be allocated into experimental and control group, respectively.
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on the 2nd and 5th day after surgery.
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Amount of drainage
기간: Until the drainage removal, average of 1 to 2 days after surgery
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Total amount of subcutaneous indwelled drainage before removal of it.
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Until the drainage removal, average of 1 to 2 days after surgery
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Hemoglobin drop on the 2nd day after surgery
기간: On the 2nd day after surgery
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The hemoglobin drop calculated by subtracting hemoglobin level of postoperative 2nd day from the preoperative value
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On the 2nd day after surgery
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Hemoglobin drop on the 5th day after surgery
기간: On the 5th day after surgery
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The hemoglobin drop calculated by subtracting hemoglobin level of postoperative 5th day from the preoperative value
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On the 5th day after surgery
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Tae Kyun Kim, MD, PhD, Joint Reconstruction Center, Seoul National University Bundang Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2013년 2월 1일
기본 완료 (예상)
2014년 12월 1일
연구 완료 (예상)
2015년 1월 1일
연구 등록 날짜
최초 제출
2013년 2월 20일
QC 기준을 충족하는 최초 제출
2013년 4월 15일
처음 게시됨 (추정)
2013년 4월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 5월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 5월 18일
마지막으로 확인됨
2014년 5월 1일
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. .