Comparison of Clinical Outcomes and Performance of Total Knee Replacement Patients Before and After Surgery (TKR)
Comparison of Clinical Scales and Quantitative Knee Motion Data in Assessing the Clinical Outcomes and Performance of Total Knee Replacement Patients Before and After Surgery
This study is to determine the relevancy of clinical scales for outcome measures as compared to flexion angle and other gait measures. Clinical outcomes measures in the form of the Knee Society Score and the WOMAC Score will be obtained from patients. Gait data will also be obtained from total knee replacement (TKR) patients at pre-operative and post-operative times. Gait data will be measured on unaffected normal controls as a second baseline.
The hypothesis is that the subjects clinical outcome measures do not accurately reflect gait dependent outcomes amd functional performance of the total knee replacement.
調査の概要
状態
詳細な説明
Patients scheduled to undergo unilateral total knee replacement (TKR) surgery will be the subjects of the study. A control group of Healthy volunteers, will serve as a control group. The control group will be matched as close as possible by age and gender to the TKR group. Both pre and post-operative (3 weeks, 6, 9 and 12 months follow-up) measurements will be performed on the TKR group.
A Intelligent Device for Energy Expenditure and Activity (IDEEA) will be used to record body motion, the sensors for the IDEEA device will be placed on the patient and secured with adhesive tape(if not allergic) once the IDEEA device is properly placed on the patient, measuring and calibrating can start.
The patient will be required to perform tasks, walking at a normal pace for approximately 100 feet on a level surface, walk up and down moderate incline ramp, climb stairs 7 to 8 steps, sit and rise from two chairs. Parameters will be measured on each subject, knee flexion angle( walking, stair climbing and sitting), velocity ( walking and stair climbing), Stride length (walking), Energy (walking, stair climbing, and sitting), other parameters will be added as needed.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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California
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San Bernardino、California、アメリカ、92408
- Loma Linda University Healthcare, Deptartment of Orthopaedic Surgery
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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
説明
Inclusion Criteria:
- Healthy
- needs unilateral total knee replacement
Exclusion Criteria:
- Active infection
- Autoimmune disease/ parkinson's disease
- HIV
- psychosocial disorders that would preclude accurate evaluation or substance abuse
- allergic to
- pregnant
- active malignancy
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
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 |
|---|---|---|
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Comparison of Clinical Outcomes and Performance of Total Knee Replacement Patient before and after surgery
時間枠：36 months
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To determine the relevancy of clinical scales for outcome measures as compared to flexion angle and other gait measures.
Clinical measures in the form of the Knee Society Score and the WOMAC Score will be obtained from patients.
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36 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Gary D. Botimer, M.D.、Loma Linda University Medical Center
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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痛みの臨床試験
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Dexa Medica Group完了