Journey II vs Persona Knee Systems - RCT
Comparison of Patients-reported Outcome After Total Knee Arthroplasty With Use of Bi-cruciate Stabilized and Personalized Implant Design - Randomized Controlled Trial
調査の概要
詳細な説明
The aim of this study is to assess patient-reported outcome, survivorship and radiological analysis in patients after total knee arthroplasty, who will undergo the surgery with the use of either Zimmer Biomet PERSONA Posterior Stabilized (PS) system and Smith&Nephew Journey II Bi-Cruciate Stabilized (BCS) system.
To this study 45 consecutive patients undergoing total knee arthroplasty will be recruited to each group. Study protocol is designed as a prospective, blinded, parallel-group, superiority trial, with balanced randomization [1:1]. All participants will be operated in single clinical orthopedic department, by single high-volume surgeon, who performed more than 3000 total knee arthroplasties in his professional career.
Before the surgery patients will fulfill the author's questionnaire concerning their age, height and body mass, level of activity, WOMAC and KOOS scales.
1-day posteoperatively patients will undergo standard computed tomography examination to assess components placement
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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Mazovia
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Warsaw、Mazovia、ポーランド、04-749
- Department of Othopedics and Rehabilitation, Medical University of Warsaw
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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:
- Listed for a primary total knee replacement (TKR) at the Orthopaedic and Rehabilitation Department Medical University of Warsaw
- Indication for the TKR is primary osteoarthritis of the knee joint involving one or more compartments
- Aged 18 or over
- Patient willing to provide full informed consent to the trial
Exclusion Criteria:
- Listed for a single-stage bilateral TKR procedure
- Severe symptoms in the contralateral knee so as to require staged bilateral knee replacements within 6 months of the primary procedure
- Fixed flexion deformity of 15 degrees or greater who will require excessive resection of the distal femur
- Clinically assessed uncorrectable varus/valgus deformity of 15 degrees or greater
- Any co-morbidity which, in the opinion of the investigator, is severe enough to present an unacceptable risk to the patient's safety
- Inflammatory arthritis
- Previous septic arthritis in the affected knee joint
- Previous surgery to the collateral ligaments of the affected knee
- Patients on warfarin or novel oral anticoagulants (NOACs)
- Will not be resident in the catchment area for at least 6 months post-surgery
- Undertaking the surgery as a private patient
- Patients who, in the opinion of the clinical staff, do not have capacity to consent
- Patients who are pregnant
- Unable to understand written and spoken Polish
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:ダブル
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:PERSONA
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Zimmer Biomet PERSONA system
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Participant will undergo total knee replacement performed via anterior parapatellar approach with either PERSONA PS or JOURNEY II BCS
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アクティブコンパレータ:Journey II
Patients undergoing total knee replacement for treatment of primary knee ostearthritis with use of Smith&Nephew Journey II system
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Participant will undergo total knee replacement performed via anterior parapatellar approach with either PERSONA PS or JOURNEY II BCS
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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 |
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Changes in patients reported outcome measures - KOOS Score (Knee injury and Osteoarthritis Outcome Score)
時間枠:baseline (preoperatively) and 1 year postoperatively
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To explore differences between outcome in patients treated with use of with Journey II and Persona prosthesis.
Results range from 0 to 100, with higher scores corresponding to better outcomes.
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baseline (preoperatively) and 1 year postoperatively
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Changes in patients reported outcome measures - WOMAC Score (Knee injury and Osteoarthritis Outcome Score)
時間枠:baseline (preoperatively) and 1 year postoperatively
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To explore differences between outcome in patients treated with use of with Journey II and Persona prosthesis.
Results range from 0 to 96, with higher scores corresponding to worse outcomes.
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baseline (preoperatively) and 1 year postoperatively
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Values of components rotation
時間枠:1-day postoperatively
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Values of external or internal rotation of components measured in computed tomography postoperatively.
Values in degrees in regards to anatomic bone landmarks
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1-day postoperatively
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協力者と研究者
捜査官
- 主任研究者:Artur Stolaerczyk, MD, PhD、Department of Orthopedics and Rehabilitation, Medical University of Warsaw
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 (実際)
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
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。
Total Knee Replacementの臨床試験
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Stryker South Pacificまだ募集していません
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University of OxfordUniversity of Copenhagen; Zimmer Biometわからない
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Stryker Orthopaedics完了関節形成術、交換、膝オランダ, イギリス, オーストリア, ドイツ
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Smith & Nephew, Inc.Nor Consult完了Journey II CR トータルニーシステムアメリカ
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Smith & Nephew, Inc.完了Journey II BCS トータルニーシステムアメリカ, ベルギー, ニュージーランド