- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07655726
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Bertrand SONNERY-COTTET
- Telefonnummer: + 33 4 37 53 00 22
- E-post: sonnerycottet@aol.com
Studieorter
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-
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Lyon, Frankrike, 69008
- Hôpital privé Jean Mermoz
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Kontakt:
- Bertrand SONNERY-COTTET, MD
- Telefonnummer: + 33 4 37 53 00 22
- E-post: sonnerycottet@aol.com
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Knee cinematics
Tidsram: 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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Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026-A00868-43
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