Effects of Unloader Bracing in Clinical Outcome and Cartilage Physiology Following Microfracture of Chondral Defects (Mfxbracing)
Effects of Unloader Bracing in Clinical Outcome and Articular Cartilage Physiology Following Microfracture of Isolated Chondral Defects
The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.
The surgery performed will be the same for all patients
The length of follow up and schedule of post-operative MRI will be the same for all patients.
The only difference in groups will be presence of absence of brace wear.
調査の概要
詳細な説明
The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Radiographic outcome will be assessed via MRI scans post-operatively. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.
The surgery performed will be the same for all patients
The length of follow up and schedule of post-operative MRI will be the same for all patients.
The only difference in groups will be presence of absence of brace wear.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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California
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Redwood City、California、アメリカ、94063
- Stanford University Medical Center
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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
説明
Inclusion Criteria:
- isolated chondral defect of medial or lateral femoral condyle 2cm squared or less
- age 15-40
- neutral knee alignment
Exclusion Criteria:
- prior cartilage procedures performed in the same knee
- other significant knee pathology including meniscus tears, ligament tears or inflammatory arthritis
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Unloader Bracing
This group will be randomly selected and assigned to wear an unloader brace post-operatively during the study period.
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The bracing arm patients will be randomly selected and will wear an unloader brace post-operatively during the study period.
他の名前：
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アクティブコンパレータ：Non-Bracing Arm
This group will be randomly selected and assigned to wear no brace post-operatively.
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Microfracture performed with no post-operative unloader bracing
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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 |
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome)
時間枠：2 years
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KOOS is a validated outcome score that evaluates knee symptoms, knee pain, knee use in activities of daily living, function in sport and recreation and knee-related quality of life.
Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures.
Scores between 0 and 100 represent the percentage of total possible score achieved.
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2 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Tegner Score (Clinical Outcome)
時間枠：2 years
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The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports.
The patient is asked to select the level of participation that best describes their current level of activity and that before injury.
A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports.
A score >6 can only be achieved if the person participates in recreational or competitive sport.
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2 years
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Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome)
時間枠：2 years
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SF-12 scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life.
A higher value indicates a better quality of life of the patient.
The scores range from 0 to 100.
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2 years
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Change From Baseline in Lysholm Score (Clinical Outcome)
時間枠：2 years
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The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function.
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2 years
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Change From Baseline in T2 Relaxation Time (Radiographic Outcome)
時間枠：2 years
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T2 imaging assesses hydration of cartilage as well as collagen fiber orientation and loss of type II collagen.
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2 years
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Change From Baseline in Cartilage Volume (Radiographic Outcome)
時間枠：2 years
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2 years
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Change From Baseline in Cartilage Thickness (Radiographic Outcome)
時間枠：2 years
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2 years
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Jason Dragoo, MD、Stanford University
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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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