Loaded and Unloaded Magnetic Resonance (MR) Imaging of Meniscus-Cartilage-Trabecular Bone in Osteoarthritis
調査の概要
詳細な説明
Variables of gait mechanics during walking have been linked to the onset and progression of knee osteoarthritis (OA). The knee adduction moment is one key variable that has been identified as an important indicator of medial compartment loads across the knee joint. Use of gait-retraining strategies to alter gait movement patterns and lower the knee adduction movement in persons with knee OA is a new and promising direction for the potential intervention in a population in which few strategies have worked successfully.
Factors that affect cartilage composition are crucial to understanding the disease mechanisms in knee OA. A multi-scale approach towards understanding the knee OA disease process by evaluating tissue compositional changes, joint contact mechanics, whole-body neuromuscular dynamics, and functional performance. The results will be the first to show the association between cartilage composition and daily function (performance and patterns) which are implicated in OA development and progression. With the addition of comprehensive muscle testing (cross sectional area/volume assessment using MR, strength testing, muscle activation and co-contraction patterns during daily activities), it will be possible to study the interaction between all major tissues around the knee.
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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San Francisco、California、アメリカ、94107
- China Basin Imaging 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:
- Men and women
- At least 35 years of age
- Mild OA patients with arthritic knee symptoms and KL score of 1-2
- Severe OA patients with arthritic knee symptoms and KL score of 3-4
- Knee symptoms in OA patients is defined as pain, aching, or stiffness on most days of a month during the past year or use of medication for treatment of knee pain on most days of a month during the past year
- self reported knee pain (defined as medial compartment knee pain at least 1 day per week during each of the 6 weeks prior to participation) and at least 3 of the following 6 clinical indicators: Age>50 years; morning stiffness<30 minutes duration; crepitus on active motion; tenderness of the bony margins of the knee joint; bony enlargement at the knee; and lack of palpable warmth of the synovium
Exclusion Criteria:
- current use of investigational drug
- conditions other than OA which limit lower extremity function and mobility and/or would confound the evaluation of function (e.g., clinically significant spinal disc degeneration, painful or dysfunctional feet, peripheral vascular disease, lumbar radiculopathy, trochanteric bursitis, hip pain, lumbar pain)
- Patients with metallic fragments in the eyes, vascular clips, pacemakers, and other contraindications to MRI
- History of joint replacement, intra-articular fracture, osteotomy, arthroplasty or meniscectomy of the signal knee
- History of other disease that may involve the study joint including systemic inflammatory disease, crystalline disease, knee infection of the signal knee, avascular necrosis, Paget's disease or tumors
- Self reported heart condition that limits any daily physical activity
- Patients who are pregnant
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：防止
- 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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アクティブコンパレータ：Moderate gait retraining
a moderate 7 degree toe-in modification
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アクティブコンパレータ：Mild gait retraining
A 2 degree toe-in gait retraining
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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 |
|---|---|---|
|
Effects of moderate versus mild gait retraining on pain, function,and kinematics and kinetics during gait and stair climing in persons with symptomatic knee OA
時間枠：up to 6 months
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Everybody walks a little different. Some people walk with their toes pointed outwards (duck-footed) and other with their toes pointed straight or even inward(pigeon-toed). We will work with participants to teach you how to walk with slightly different toe angle. Participants will be randomly assign to each group and will be taught on this new walking pattern. Gait modification is a non-surgical treatment that can reduce the KAM (knee adduction moment). Changes to foot progression angle, tibia angle, hip adduction/internal rotation and trunk sway can reduce the KAM from baseline. Modifications involving simultaneous changes to multiple gait parameters have also been shown to reduce KAM. |
up to 6 months
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協力者と研究者
捜査官
- 主任研究者：Sharmila Majumdar, PhD、UCSF, Department of Radiology and Biomedical Imaging
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 (実際)
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最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。