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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.

Studieoversigt

Status

Ikke rekrutterer endnu

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

      • Lyon, Frankrig, 69008
        • Hôpital privé Jean Mermoz
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Knee cinematics
Intraoperative morpho-functional analysis of the injured knee
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Knee cinematics
Tidsramme: Day 0

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:

  • Femoro-tibial distance for the insertion of the LLE
  • Femoro-tibial distance for the insertion of the LLI
  • Femoro-tibial distance for the insertion of the ACL (before graft placement)
  • Distance between the centres of the intra-articular openings of the femoral and tibial tunnels (after graft placement)
  • Femoro-tibial distance for the insertion of the PCL
Day 0

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2027

Primær færdiggørelse (Anslået)

1. marts 2028

Studieafslutning (Anslået)

1. marts 2028

Datoer for studieregistrering

Først indsendt

13. juni 2026

Først indsendt, der opfyldte QC-kriterier

13. juni 2026

Først opslået (Faktiske)

18. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-A00868-43

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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