ACL - Anterior Cruciate Ligament RuptureCINEGENNCT07655726
Intraoperative Analysis of Knee Kinematics During ACL Reconstruction - an Exploratory Study
A study testing Knee Cinematics in people with ACL - Anterior Cruciate Ligament Rupture, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- ACL - Anterior Cruciate Ligament Rupture
- What is being tested?
- Knee Cinematics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2027to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Privé Jean Mermoz
Lyon, 69008
Bertrand SONNERY-COTTET, MD, + 33 4 37 53 00 22, sonnerycottet@aol.com
About this study
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.
Read the detailed description
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.
- Conditions
- ACL - Anterior Cruciate Ligament Rupture
- Being tested
- Knee Cinematics
- Keywords
- ACL rupture, Knee cinematics
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee CinematicsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Knee cinematics | Experimental | Intraoperative morpho-functional analysis of the injured knee Receives: Procedure: Knee Cinematics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study startJul 2027 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL - Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655726
- Sponsor's protocol ID
- 2026-A00868-43
- Acronym
- CINEGEN
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Analysis of Knee Kinematics During ACL Reconstruction - an Exploratory Study
- ClinicalTrials.gov ID
- NCT07655726
- Acronym / sponsor ID
- CINEGEN / 2026-A00868-43
- Conditions
- ACL - Anterior Cruciate Ligament Rupture
- Keywords
- ACL rupture, Knee cinematics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- Jul 2027 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee cinematics | Experimental | Procedure: Knee CinematicsIntraoperative morpho-functional analysis of the injured knee |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knee CinematicsThe 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. | Procedure or surgery | Knee cinematics |
Primary outcome
Knee cinematics
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee Cinematics in people with ACL - Anterior Cruciate Ligament Rupture, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bertrand SONNERY-COTTET (+ 33 4 37 53 00 22, sonnerycottet@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee cinematics (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.