Assessment of Knee Arthrosis After Bariatric Surgery (BASIK)
Assessment of Knee Arthrosis in Severely Obese Patients After Bariatric Surgery.
Impact of loss of weight on knee arthrosis has not been thoroughly studied. The primary goal of this study is to compare the MRI parameters (aspect of cartilage and oedema of spongious sub-chondral bone) before and one year after bariatric surgery.
Knee MRI is not currently part of the investigations preceding bariatric surgery.
연구 개요
상세 설명
Assessment of knee arthrosis in severely obese patients after bariatric surgery.
Impact of loss of weight on knee arthrosis has not been thoroughly studied. The primary goal of this study is to compare the MRI parameters (aspect of cartilage and oedema of spongious sub-chondral bone) before and one year after bariatric surgery.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Colombes, 프랑스
- Louis Mourier Hospital (AP-HP)
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Inclusion Criteria:
- bariatric surgery
- IMC >= 35
Exclusion Criteria:
- those of bariatric surgery
- contra-indication to MRI
- pregnancy
설명
Inclusion Criteria:
- bariatric surgery
- IMC >= 35
Exclusion Criteria:
- those of bariatric surgery
- contra-indication to MRI
- pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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knee MRI
knee MRI for all patients undergoing bariatric surgery as usual care
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knee MRI before surgery (inclusion) and one year after
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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variation of knee joint space thickness
기간: 24 hours, one year
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Joint space variation in percentages (mean joint space variation calculated for each patient group).
Mean joint space comparison between 2 groups of obese patients: patients with Bypass surgery versus patients without surgery.
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24 hours, one year
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proportion of patients with pain
기간: 1 year
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proportion of patients with Pain Scores on the Visual Analog Scale ≥ 30/100 (for at least one knee).
Comparison at one year after bariatric surgery versus inclusion.
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1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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prevalence of atherosis
기간: 24 hours
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Pain Scores on the Visual Analog Scale >= 3 and/or radiological signs of atherosis
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24 hours
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mean pain and disability
기간: 24 hours
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mean Pain Scores on the Visual Analog Scale and mean value of KOOS index for knee function.
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24 hours
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evolution of KOOS score after surgery
기간: 6 months, 1 year and two years
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Among the 80 patients undergoing surgery, comparison of KOOS function score before surgery versus 6 months, 1 year and two years after surgery.
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6 months, 1 year and two years
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evolution of pain scores after surgery
기간: 6 months, 1 year, 2 years
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Among the 80 patients undergoing surgery, comparison of mean Pain Scores on the Visual Analog Scale before surgery versus 6 months, 1 year and two years after surgery.
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6 months, 1 year, 2 years
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evolution of the proportion of patients in pain
기간: 6 months, 1 year and two years
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Among the 80 patients undergoing surgery, comparison of the proportion of patients with Pain Scores on the Visual Analog Scale ≥ 30/100 before surgery versus 6 months, 1 year and two years after surgery.
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6 months, 1 year and two years
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evolution of knee MRI parameters after surgery
기간: 6 months, 1 year and two years
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Among the 80 patients undergoing surgery, comparison of the MRI parameters (T2, cartilage volume, œdema of sub-chondral spongious bone) before surgery versus 6 months, 1 year and two years after surgery.
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6 months, 1 year and two years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Elisabeth Dion, MD, Phd, Louis Mourier University Hospital (AP-HP)
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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