Knee Positioning After Total Knee Replacement
2026년 7월 30일 업데이트: Brett Hayden, Icahn School of Medicine at Mount Sinai
The Effects of Postoperative Positioning in Knee Flexion Versus Usual Care After Total Knee Arthroplasty: A Randomized Controlled Trial
Many total knee replacements are performed each year, but there is no clear recommendation regarding knee positioning following this surgery.
While the surgical knee is usually positioned in a straight position immediately after surgery, there may be benefits of positioning it in a partially bent position.
A trial will compare the outcomes of two groups of patients: a) those whose knees are positioned in a partially bent position for a few hours after surgery and b) those who receive usual care where the knee is most likely positioned in a straight position.
The investigators are looking to see whether knee motion and pain differ for patients in the two groups.
연구 개요
상세 설명
This parallel two-arm randomized controlled trial will compare outcomes for knee flexion versus usual care in the immediate postoperative period after total knee arthroplasty.
Patients who are scheduled for elective primary unilateral total knee arthroplasty will be recruited from an academic health system, screened for inclusion/exclusion criteria, and enrolled.
The experimental group will have their surgical knee positioned in approximately 60° of flexion for 2-4 hours after surgery.
The control group will receive usual care, where the knee will generally be positioned in extension.
Other than the study intervention, both groups will receive standard perioperative, intraoperative, and postoperative care as determined by their treating clinical team.
The co-primary endpoints are 6-week knee passive total arc of motion and 7-day maximum pain intensity.
Secondary outcomes will be assessed throughout the 12 months after surgery and will include knee motion and pain intensity at other time points; oral opioid consumption; patient-reported questionnaires of knee health, quality of life, and satisfaction; healthcare utilization; and complications.
Adverse events will also be monitored for the 12 months after surgery.
Outcomes will be assessed via phone or electronic surveys; routine care visits at 2.5 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery; and chart review.
연구 유형
중재적
등록 (추정된)
150
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Brocha Stern
- 전화번호: 212-659-9650
- 이메일: brocha.stern@mountsinai.org
연구 장소
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New York
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New York, New York, 미국, 10029
- Mount Sinai Health System
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연락하다:
- Brocha Stern
- 전화번호: (212) 659-9650
- 이메일: brocha.stern@mountsinai.org
-
-
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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Males and females; Age >18 years
- Scheduled for elective primary unilateral total knee arthroplasty
- The planned arthroplasty is secondary to physician-confirmed diagnosis of knee osteoarthritis
- English- or Spanish-speaking
Exclusion Criteria:
- Patients with a history of chronic opioid use or chronic pain disorders
- Patients with a history of bleeding disorders/coagulopathy
- Patients receiving a total knee replacement secondary to trauma, avascular necrosis, tumor, or Charcot arthropathy
- Patients scheduled to undergo multiple procedures simultaneously
- Patients with cognitive impairment or inability to consent independently
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: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Knee Flexion
Participants in this arm will receive the knee flexion intervention.
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Participants will receive knee flexion postoperatively following primary total knee arthroplasty.
The surgical knee will positioned at approximately 60° flexion using an abduction pillow as a jig underneath the knee during the immediate postoperative recovery period.
Positioning will occur following surgery while the participant is still in the operating room.
This is a soft construct and a noninvasive intervention.
A goniometer will be used to approximate 60° of flexion as closely as possible.
It is expected that the knee will be positioned for 2-4 postoperative hours until a physical therapist comes to mobilize the patient.
However, the duration may vary because of the pragmatic context.
There is no minimum or maximum positioning time that would make the intervention duration ineligible.
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활성 비교기: Usual Care
Participants in this arm will receive usual care.
No specific attention will be placed to knee positioning in the immediate period after surgery.
However, the current usual practice in the health system is that the knee is positioned in extension.
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Participants in this arm will receive usual care.
No specific attention will be placed to knee positioning in the immediate period after surgery.
However, the current usual practice in the health system is that the knee is positioned in extension.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Knee Passive Total Arc of Motion
기간: At 6 weeks after surgery
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Passive total arc of motion will be evaluated through goniometric assessment of maximal passive knee flexion and passive knee extension.
Both measures will be recorded, but a single endpoint will be derived by subtracting available extension from available flexion.
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At 6 weeks after surgery
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Maximum Pain Intensity
기간: At 7 days after surgery
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Pain intensity will be evaluated via the patient-reported Numeric Rating Scale (NRS) for pain.
The rating is from 0 to 10, with a higher score indicating worse pain.
The worst (i.e., maximum) pain intensity will be used.
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At 7 days after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Knee Passive Total Arc of Motion
기간: At 2.5 weeks, 3 months, 6 months, and 12 months after surgery
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Passive total arc of motion will be evaluated through goniometric assessment of maximal passive knee flexion and passive knee extension.
Both measures will be recorded, but a single endpoint will be derived by subtracting available extension from available flexion.
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At 2.5 weeks, 3 months, 6 months, and 12 months after surgery
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Maximum Pain Intensity
기간: At 0 days, 1 day, 2 days, 3 days, 10 days, 14 days, 2.5 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery
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Pain intensity will be evaluated via the patient-reported Numeric Rating Scale (NRS) for pain.
The rating is from 0 to 10, with a higher score indicating worse pain.
The worst (i.e., maximum) pain intensity will be used.
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At 0 days, 1 day, 2 days, 3 days, 10 days, 14 days, 2.5 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery
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Total Opioid Consumption
기간: Postoperative days 0 through 14
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Consumption of opioids standardized in oral morphine milligram equivalents based on medical records for in-hospital administration, prescriptions, and patient report for at-home consumption.
Consumption will be summed across days, with higher numbers indicating greater opioid consumption.
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Postoperative days 0 through 14
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Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
기간: At 6 weeks, 3 months, 6 months, and 12 months after surgery
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The Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) is a patient-reported measure of knee health (i.e., pain and function).
Scores range from 0 to 100, with higher scores indicating better health.
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At 6 weeks, 3 months, 6 months, and 12 months after surgery
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Veterans RAND 12-item Health Survey
기간: At 6 weeks, 3 months, 6 months, and 12 months after surgery
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The Veterans RAND 12-item Health Survey (VR-12) is a patient-reported measure of global physical and mental health.
It provides a physical component summary score and a mental component summary score.
These are T-scores with a mean of 50, and higher scores indicate better health.
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At 6 weeks, 3 months, 6 months, and 12 months after surgery
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Goodman Satisfaction Score
기간: 12 months after surgery
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The Goodman Satisfaction Score assesses patient satisfaction with total hip or knee arthroplasty outcomes.
Scores range from 0 to 100, with higher scores indicating greater satisfaction.
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12 months after surgery
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Length of Hospital Stay
기간: Through hospital discharge, average of 1 day, up to 30 days after surgery
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Number of days the patient stays in the hospital after the index surgery.
This information will be extracted from the medical record.
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Through hospital discharge, average of 1 day, up to 30 days after surgery
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Percentage of Participants with an Emergency Department Visit
기간: Within 7 days, 30 days, and 90 days after surgery
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Percentage of participants with an all-cause emergency department visit after surgery.
This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint.
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Within 7 days, 30 days, and 90 days after surgery
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Percentage of Participants with a Hospital Readmission
기간: Within 30 days and 90 days after surgery
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Percentage of participants with an all-cause hospital readmission after surgery.
This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint.
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Within 30 days and 90 days after surgery
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Percentage of Participants with Deep Vein Thrombosis
기간: Within 30 days and 90 days after surgery
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Percentage of participants who have deep vein thrombosis after surgery.
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Within 30 days and 90 days after surgery
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Percentage of Participants with a Pulmonary Embolism
기간: Within 30 days and 90 days after surgery
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Percentage of participants who have a pulmonary embolism after surgery.
This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint.
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Within 30 days and 90 days after surgery
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Percentage of Participants with a Venous Thromboembolism
기간: Within 30 days and 90 days after surgery
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Percentage of participants who have a venous thromboembolism after surgery.
This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint.
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Within 30 days and 90 days after surgery
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Percentage of Participants with a Coronary Event
기간: Within 30 days and 90 days after surgery
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Percentage of participants who have a myocardial infarction or other coronary event after surgery.
This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint.
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Within 30 days and 90 days after surgery
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Percentage of Participants with a Stroke
기간: Within 30 days and 90 days after surgery
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Percentage of participants who have a stroke after surgery.
This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint.
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Within 30 days and 90 days after surgery
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Percentage of Participants with a Blood Transfusion
기간: Within 30 days after surgery
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Percentage of participants who receive a blood transfusion after surgery.
This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint.
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Within 30 days after surgery
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Percentage of Participants with a Wound Dehiscence
기간: Within 30 days and 90 days after surgery
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Percentage of participants who have a wound dehiscence after surgery.
This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint.
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Within 30 days and 90 days after surgery
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Percentage of Participants with a Mechanical Complication
기간: Within 30 days and 90 days after surgery
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Percentage of participants who have a mechanical complication after surgery.
This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint.
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Within 30 days and 90 days after surgery
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Percentage of Participants with a Manipulation under Anesthesia
기간: Within 12 months after surgery
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Percentage of participants who undergo a manipulation under anesthesia after surgery.
This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint.
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Within 12 months after surgery
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Percentage of Participants with a Knee Revision Surgery
기간: Within 12 months after surgery
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Percentage of participants who undergo a knee revision surgery after the index surgery.
This information will be extracted from the medical record, with supplementation by participant queries during the postoperative visit after the respective timepoint.
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Within 12 months after surgery
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Brett Hayden, MD, Icahn School of Medicine at Mount Sinai
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 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2028년 2월 1일
연구 완료 (추정된)
2029년 2월 1일
연구 등록 날짜
최초 제출
2026년 7월 30일
QC 기준을 충족하는 최초 제출
2026년 7월 30일
처음 게시됨 (실제)
2026년 8월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 30일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- Study 26-00680
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
No individual participant data is planned to be shared with other researchers.
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아니
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. .