The Knee Usual Care Evaluation Study (KUCE)
2017年11月29日 更新者：Hospital for Special Surgery, New York
Title: The Study of Intra-articular Interventions of Platelet Rich Plasma or Hyaluronic Acid Compounds vs. Usual Care (Exercise/Diet/Supplements) in the Medical Management of Knee OA- Effects on Pain and Function; Effects on Articular Cartilage; Effects on Time to Partial or Total Knee Arthroplasty: The Knee Usual Care Evaluation (KUCE) Study
The purpose of this prospective data collection is to track patients who are treated at HSS who are confirmed with knee osteoarthritis. The registry will collect prospective patient related and functional outcomes (including use of assistive devices), medication use and imaging data on patients with confirmed osteoarthritis, and the effect of different medical interventions that include PRP, Synvisc / Orthovisc /Euflexxa, bracing, suggested exercises, supplements, and diet. Information from the data collection will be used to compare outcomes of non-surgical alternatives with the end point being knee arthroplasty. The information results will enhance our knowledge of the long-term efficacy and effectiveness of non-surgical interventions intended to treat the progression of osteoarthritis.
Hypotheses:
- Different non-surgical interventions such as PRP, Synvisc®, Orthrovisc®, Euflexxa, bracing, physical therapy, and a prescribed combination of exercise, diet, and supplements will demonstrate statistically significant differences in patient pain and functional outcomes compared to usual interventions including use of NSAIDs, corticosteroid injections, and use of assistive devices such as canes.
- Non-operative interventions for knee osteoarthritis will be associated with different rates of breakdown of articular cartilage and different rates of progression of osteoarthritis as evidenced by MRI or joint space narrowing on standing knee films?
- Education about available non-operative treatment methods may change time the end point of total or partial knee replacement for patients with knee osteoarthritis of varying severity.
- Different non-operative interventions will be associated with different times to total or partial knee arthroplasty in patient with knee osteoarthritis of similar severity.
- An electronic data capture system (EDC) for osteoarthritis patients will improve patient care and patient outcomes.
調査の概要
状態
終了しました
条件
詳細な説明
Specific Aims:
- To ascertain the long term success of non-surgical interventions intended to alleviate symptoms or slow progression of osteoarthritis of the knee.
- To ascertain if non-operative interventions for knee osteoarthritis improve patient pain, function, and quality of life.
- To ascertain if non-operative interventions for knee osteoarthritis affect the breakdown of articular cartilage and slow progression of osteoarthritis as evidenced by MRI or joint space narrowing on standing knee films?
- To ascertain the amount of time between the initial entry into care at HSS and the end point of total or partial knee replacement for patients with knee osteoarthritis of varying severity.
- To ascertain if non-operative interventions for knee osteoarthritis prolong time to knee replacement surgery.
- To implement at electronic data capture system (EDC) for osteoarthritis patients which will store validated patient reported outcomes, physical findings, and imaging results.
研究の種類
観察的
入学 (実際)
906
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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New York
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New York、New York、アメリカ、10021
- Hospital for Special Surgery
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
30年～80年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Hospital for Special Surgery knee osteoarthritis patients
説明
Inclusion Criteria:
- Age greater than 30 years and less than 80 years
- Knee pain for at least 6 weeks
- Pain rate greater than or equal to 4/10 on a visual analog scale
- Morning stiffness less than 30 minutes
- Crepitus on active motion of the knee, bony tenderness, or bony enlargement of the knee
- Willing and able to consider all medical treatment options used to manage osteoarthritis of the knee
- No contraindications to knee radiographs or MRI
- Willing to participate in a registry
- Able to understand and sign a consent
- Able to answer registry questions independently
Exclusion Criteria:
- Diagnosis of a systemic rheumatic disease or crystalline arthritis (ie RA, SLE, systemic sclerosis, psoriatic arthritis or psoriasis, gout, pseudogout, lyme arthritis, reactive arthritis, viral arthritis
- pregnant or nursing
- unable to give informed consent
- contraindication to MRI such as indwelling paemaker or cochlear implant
- requirement of metal equipment (such as oxygen)
- known claustrophobia
- gadolinium allergy
- lack of fluency in English. Unfortunately, we do not have the financial resources to offer full translation services
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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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Short Form (12) Health Survey (SF-12)
時間枠：6 months, 12 months, 24 months, 36 months, 48 months and 60 months.
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Change is being assessed.
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6 months, 12 months, 24 months, 36 months, 48 months and 60 months.
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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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Knee injury and Osteoarthritis Outcome Score (KOOS)
時間枠：6 months, 12 months, 24 months, 36 months, 48 months and 60 months.
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Change is being assessed.
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6 months, 12 months, 24 months, 36 months, 48 months and 60 months.
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Whole-Organ MRI Scoring (WORMS)
時間枠：baseline, 1 year, 2 years, 5 years
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Changes in MRI will be measured by a chance in the Whole-Organ MRI Scoring (WORMS) score of femur and tibia, and Outerbridge score for cartilage.
The Boston Osteoarthritis Knee Study defined cartilage loss using the WORMS score as "an increase in the score at any sub-region compared to baseline in any of the 14 subregions of the knee scored for cartilage in each knee."
For patients who have only standing radiographs available a 0.7 mm loss of joint space will be considered a significant loss over 3 years.
Bruyere et al predicted that "the cut off for minimum JSN maximizing sensitivity and specificity for predicting future surgery was a change of 0.7 mm or more in minimum joint space width over a period of three years."
Note: change is being assessed.
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baseline, 1 year, 2 years, 5 years
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X-ray with Kellgren-Lawrence Grading
時間枠：baseline, 4 years
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Change is being assessed.
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baseline, 4 years
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- Roos EM, Roos HP, Lohmander LS. WOMAC Osteoarthritis Index--additional dimensions for use in subjects with post-traumatic osteoarthritis of the knee. Western Ontario and MacMaster Universities. Osteoarthritis Cartilage. 1999 Mar;7(2):216-21. doi: 10.1053/joca.1998.0153.
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年7月1日
一次修了 (実際)
2014年3月21日
研究の完了 (実際)
2014年3月21日
試験登録日
最初に提出
2013年7月16日
QC基準を満たした最初の提出物
2013年7月19日
最初の投稿 (見積もり)
2013年7月23日
学習記録の更新
投稿された最後の更新 (実際)
2017年12月2日
QC基準を満たした最後の更新が送信されました
2017年11月29日
最終確認日
2017年11月1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。