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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Colombes、フランス
- Louis Mourier Hospital (AP-HP)
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Inclusion Criteria:
- bariatric surgery
- IMC >= 35
Exclusion Criteria:
- those of bariatric surgery
- contra-indication to MRI
- pregnancy
説明
Inclusion Criteria:
- bariatric surgery
- IMC >= 35
Exclusion Criteria:
- those of bariatric surgery
- contra-indication to MRI
- pregnancy
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
knee MRI
knee MRI for all patients undergoing bariatric surgery as usual care
|
knee MRI before surgery (inclusion) and one year after
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
variation of knee joint space thickness
時間枠：24 hours, one year
|
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
|
|
proportion of patients with pain
時間枠：1 year
|
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.
|
1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
prevalence of atherosis
時間枠：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
時間枠：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
|
|
evolution of KOOS score after surgery
時間枠：6 months, 1 year and two years
|
Among the 80 patients undergoing surgery, comparison of KOOS function score before surgery versus 6 months, 1 year and two years after surgery.
|
6 months, 1 year and two years
|
|
evolution of pain scores after surgery
時間枠：6 months, 1 year, 2 years
|
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
|
|
evolution of the proportion of patients in pain
時間枠：6 months, 1 year and two years
|
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
|
|
evolution of knee MRI parameters after surgery
時間枠：6 months, 1 year and two years
|
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
|
協力者と研究者
捜査官
- 主任研究者：Elisabeth Dion, MD, Phd、Louis Mourier University Hospital (AP-HP)
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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