Intraoperative Analysis of Knee Kinematics During ACL Reconstruction - an Exploratory Study (CINEGEN)
Reconstruction of anterior cruciate ligament (ACL) is a common procedure in orthopaedic surgery, aimed at restoring stability to your knee. This procedure involves performing an anterior cruciate ligament (ACL) graft and an anterolateral ligament (ALL) graft.
Despite technological advances and improvements in surgical techniques, failure rates remain high. In this context, a better understanding of knee movements (the position of the femur and tibia, as well as the ligaments) during flexion whilst reconstructing your ACL could improve the precision of reconstructions and reduce the long-term failure rate.
Using a surgical navigation system, it is possible to record data on the positioning of the femur and tibia during flexion and extension. This type of morpho-functional analysis of knee kinematics during ACL reconstruction has never been carried out before.
調査の概要
詳細な説明
Anterior cruciate ligament reconstruction is a common procedure in orthopaedic surgery, aimed at restoring knee stability following a ligament rupture. Despite technological advances and improvements in surgical techniques, failure rates remain a cause for concern.
There are many causes of ligament reconstruction failure, including biological factors (e.g. poor graft integration), repeated trauma and technical errors. Among the latter, poor tunnel positioning is the main cause, accounting for up to 29% of errors, the majority of which (75%) involve the femoral tunnel. Biomechanical studies have confirmed that inadequate positioning of the femoral tunnel alters knee kinematics, increasing stress on the graft and predisposing it to secondary rupture. In this context, a better understanding of intra-articular knee movements and the tension/relaxation profiles of the knee ligaments during flexion movements in surgery could improve the accuracy of reconstructions and reduce the long-term failure rate.
Using a surgical navigation system, it is possible to record data on the dynamic positioning of the femur and tibia during flexion and extension. MRI imaging also makes it possible to generate a digital twin of the patient's knee, including the patient's ligaments and their bony attachments. Aligning this digital twin with the positions of the femur and tibia recorded using intraoperative navigation makes it possible to determine, at different angles of flexion, the position of the digital twin and thus to measure the distance between the ligament insertions in the knee. This type of morpho-functional analysis of the 3D kinematics of the knee has not been published. This is why this research is initiated.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Bertrand SONNERY-COTTET
- 電話番号:+ 33 4 37 53 00 22
- メール:sonnerycottet@aol.com
研究場所
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Lyon、フランス、69008
- Hôpital Privé Jean Mermoz
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コンタクト:
- Bertrand SONNERY-COTTET, MD
- 電話番号:+ 33 4 37 53 00 22
- メール:sonnerycottet@aol.com
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patient, male or female, aged between 18 and 40
- Patient eligible for ACL and LAL reconstruction
- Patient who is member of or covered by a social security scheme
- Patient who speaks French and has signed an informed consent form
Exclusion Criteria:
- Patient with a contraindication to MRI
- Patient with osteoarthritis of the joint
- Patient with a BMI > 30
- Patient with history of trauma or previous knee surgery
- Patient with knee trauma other than a sprain
- Patient under legal guardianship: an adult under guardianship, curatorship or other legal protection, or deprived of liberty by judicial or administrative order
- Pregnant or breastfeeding woman
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:基礎科学
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- 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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実験的:Knee cinematics
Intraoperative morpho-functional analysis of the injured knee
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The pins used for ACL reconstruction will serve as a mount for the optical markers used to record the position data of the femur and tibia during ACL reconstruction.
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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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Knee cinematics
時間枠:Day 0
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The kinematic changes in the knee resulting from ACL reconstruction in flexion (at 90° and 45°) and in extension will be assessed intraoperatively, based on the following distances measured before and after placement of the ACL graft:
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Day 0
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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。