肥満患者に人工膝関節全置換術を施行する際に得られるアライメントにおけるナビゲーションの使用の効果
NAOBE is a randomized, open and prospective clinical trial that evaluates the accuracy to achieve an adequate mechanical axis of the lower extremity in obese patients after total knee replacement.
調査の概要
状態
詳細な説明
Randomized, open and prospective clinical trial.
Following the surgical indication for a total knee replacement as treatment for symptomatic osteoarthritis and the confirmation of obesity (BMI equal or greater than 30 Kg/m2 ), patients will be randomly assigned (ratio 1:1) to one of the following treatments:
Control group: Total knee arthroplasty implanted with standard guides . Experimental group: Total knee arthroplasty(TKA) implanted with GPS navigation system Patient (or their legal guardian) must provide/sign the informed consent prior to inclusion in the study.
After the surgery, patients will be followed-up at 6 weeks, 3, 6 and 12 months. At those times, data regarding physical and radiological examinations, pain and functionality and health status questionnaires will be collected.
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
-
-
Madrid
-
Madrid、Madrid、スペイン、28009
- Hospital Universitario Santa Cristina
-
Majadahonda、Madrid、スペイン、28222
- Hospital Universitario Puerta de Hierro Majadahonda
-
-
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 over 18 years old.
- Written informed consent according to ICH / GCP and Spanish legislation, obtained before any study procedure.
- Patient with a BMI equal to or greater than 30 Kg / m2
- Patients with clinical and radiological criteria of knee osteoarthritis.
- Patients with indication for primary TKA according to medical criteria.
Exclusion Criteria:
- Pregnancy or lactation.
- Inability to give informed consent in the absence of a legal representative.
- Subjects that are participating in a study with medicines or other medical devices.
- Those who show inability to follow the instructions or collaborate during the development of the study.
- If in the opinion of the researcher there are findings in the physical examination, abnormalities in the results of the clinical analyzes or other medical, social or psychosocial factors that could have a negative influence
- Having had a previous surgical procedure on or around the knee in the last 12 months (such as proximal tibial osteotomy, femoral osteotomy, open reduction and internal fixation for a fracture, patellectomy or patellar realignment).
- Need a simultaneous bilateral TKA.
- Have a varus angle or valgus ≥ 15 °.
- Total revision knee arthroplasty.
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 |
|---|---|
|
実験的：Experimental
Total knee arthroplasty implanted with GPS navigation system. |
Obese patients undergoing Total Knee Arthroplasty, GPS achieved alignment |
|
アクティブコンパレータ：Control
Total knee arthroplasty implanted with standard guides. |
Obese patients undergoing Total Knee Arthroplasty, alignment achieved by using standard guides |
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 |
|---|---|---|
|
Deviation in a mechanical axis of knees
時間枠：12 months
|
Proportion of knees after surgery with a mechanical axis with a deviation greater than 3º |
12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Radiological axes (femoral)
時間枠：12 months
|
Position angle of the femoral component: angle formed between the anatomical axis of the femur and the articular surface of the femoral component of the TKA (α). |
12 months
|
|
Radiological axes (tibial)
時間枠：12 months
|
Position angle of the tibial component: angle formed between the anatomical axis of the tibia and the proximal surface of the tibial component of the TKA (β). |
12 months
|
|
Surgical procedure time
時間枠：Week 1
|
Surgical time |
Week 1
|
|
Admission (hospital) duration
時間枠：Week 1
|
Number of days of the hospital admission |
Week 1
|
|
Number of Surgical complications (Intraoperative)
時間枠：Week 1
|
Intraoperative complications |
Week 1
|
|
Number of Surgical complications (perioperative)
時間枠：1 to 6 weeks
|
perioperative complications |
1 to 6 weeks
|
|
Number of Surgical complications (post-operative)
時間枠：1-12 months
|
postoperative complications |
1-12 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Knee Society Score Questionaire
時間枠：6 weeks-12 months
|
KSS Questionaire, developed by the Knee Society, assesses the function of the knee replacement and the functional capabilities of patients after their implantation. It has to separate sections ("Knee Score" and "Functional Score") that are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. |
6 weeks-12 months
|
|
Range of Motion
時間枠：6 weeks-12 months
|
The maximum extension and flexion |
6 weeks-12 months
|
|
Visual Analogic Scale for pain
時間枠：1-12 months
|
VAS measure the intensity of the pain that the patient describes. It consists of a horizontal line of 10 centimeters, with 0cm being "no pain" and 10cm being "extreme pain". |
1-12 months
|
協力者と研究者
捜査官
- 主任研究者：Pedro José Torrijos Garrido, MD, PhD、Hospital Universitario Puerta de Hierro
出版物と役立つリンク
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
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