Prospective Randomized Trial of Navigated and Conventional TKA
Prospective Randomized Trial of Navigated and Conventional TKA With Radiographic and CT Evaluations
調査の概要
詳細な説明
Component position, kinematics After skin closure lateral x-rays were done in different flexion angles in order to evaluate the kinematic behaviour of the TKA.
A full-length standing and a lateral radiograph as well as CT scans of the hip, knee and ankle joint were performed 5 to 7 days postoperatively before discharge.
- clinical outcome Patient sociodemographic and anamnestic data were collected. The written interview was complemented by the EuroQol questionnaire (release EQ-5D) and the assessment of the patients' functional status (Knee Society Score) one week before surgery and 18 to 24 month after surgery.
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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Dresden、ドイツ、01307
- University Hospital Dresden, Orthopaedic Department
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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:
- primary or secondary osteoarthritis of the knee
- indication to TKA
- a mechanical axis between 20° varus and 5° valgus
- signed informed consent
Exclusion Criteria:
- previous hemi- or total arthroplasty
- severe instability that could not be treated with an unconstrained, cruciate-retaining TKA
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：なし（オープンラベル）
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：navigated TKA
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In all patients a cemented, unconstrained, cruciate-retaining TKA with a rotating platform (ScorpioTM PCS, Stryker Orthopaedics, Mahwah, NJ) was implanted. No patellar resurfacing was performed. A medial parapatellar approach with a femur-first preparation was done in all cases. The Stryker Navigation System, Knee Navigation Software V3.1 (Stryker Orthopaedics, Mahwah, NJ) was used for computer-assisted implantation. The conventional implantation was performed with femoral intramedullary and tibial extramedullary standard alignment guides.
他の名前：
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他の：conventional TKA
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In all patients a cemented, unconstrained, cruciate-retaining TKA with a rotating platform (ScorpioTM PCS, Stryker Orthopaedics, Mahwah, NJ) was implanted. No patellar resurfacing was performed. A medial parapatellar approach with a femur-first preparation was done in all cases. The Stryker Navigation System, Knee Navigation Software V3.1 (Stryker Orthopaedics, Mahwah, NJ) was used for computer-assisted implantation. The conventional implantation was performed with femoral intramedullary and tibial extramedullary standard alignment guides.
他の名前：
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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 |
時間枠 |
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rotational component position
時間枠：postoperatively
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postoperatively
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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leg axis
時間枠：postoperatively
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postoperatively
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kinematics
時間枠：postoperatively
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postoperatively
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clinical outcome
時間枠：18 to 24 month postoperatively
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18 to 24 month postoperatively
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協力者と研究者
捜査官
- スタディディレクター：Klaus-Peter Günther, MD, PhD、Orthopaedic Department, University Hospital Dresden
出版物と役立つリンク
一般刊行物
- Lutzner J, Krummenauer F, Wolf C, Gunther KP, Kirschner S. Computer-assisted and conventional total knee replacement: a comparative, prospective, randomised study with radiological and CT evaluation. J Bone Joint Surg Br. 2008 Aug;90(8):1039-44. doi: 10.1302/0301-620X.90B8.20553.
- Beyer F, Pape A, Lutzner C, Kirschner S, Lutzner J. Similar outcomes in computer-assisted and conventional total knee arthroplasty: ten-year results of a prospective randomized study. BMC Musculoskelet Disord. 2021 Aug 18;22(1):707. doi: 10.1186/s12891-021-04556-3.
- Harman MK, Banks SA, Kirschner S, Lutzner J. Prosthesis alignment affects axial rotation motion after total knee replacement: a prospective in vivo study combining computed tomography and fluoroscopic evaluations. BMC Musculoskelet Disord. 2012 Oct 23;13:206. doi: 10.1186/1471-2474-13-206.
- Lutzner J, Krummenauer F, Gunther KP, Kirschner S. Rotational alignment of the tibial component in total knee arthroplasty is better at the medial third of tibial tuberosity than at the medial border. BMC Musculoskelet Disord. 2010 Mar 25;11:57. doi: 10.1186/1471-2474-11-57.
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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