NCT07655726

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jul 2027

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
1 year until next milestone

Study Start

First participant enrolled

July 1, 2027

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

8 months

First QC Date

June 13, 2026

Last Update Submit

June 13, 2026

Conditions

Keywords

ACL ruptureKnee cinematics

Outcome Measures

Primary Outcomes (1)

  • Knee cinematics

    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

Study Arms (1)

Knee cinematics

EXPERIMENTAL

Intraoperative morpho-functional analysis of the injured knee

Procedure: Knee Cinematics

Interventions

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.

Knee cinematics

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Privé Jean Mermoz

Lyon, 69008, France

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Central Study Contacts

Bertrand SONNERY-COTTET

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2026

First Posted

June 18, 2026

Study Start (Estimated)

July 1, 2027

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

June 18, 2026

Record last verified: 2026-06

Locations