ACL InjuryTRACTOLCANCT05806034
Evaluation of Anterior Cruciate Ligament Tears Using Diffusion Tractography
A study testing tractography MRI sequence protocol in people with ACL Injury and MRI, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Knees injuries commonly affect the ACL. French current methodology is based on MRI focused on the knee with morphological sequences (T1, DP fat sat) allowing the study of ACL as follows: No lesion / Partial tear / Complete tear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACL Injury, MRI, Tractography
- What is being tested?
- tractography MRI sequence protocol
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2023to 21 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old,
- Patient referred for non-enhanced knee MRI for traumatism.
- Affiliation to a social security program,
Who cannot join
- Person under guardianship or curators,
- Any contraindications to MRI
Trial locations and contacts
1 site in 1 country.
About this study
Knees injuries commonly affect the ACL. French current methodology is based on MRI focused on the knee with morphological sequences (T1, DP fat sat) allowing the study of ACL as follows: No lesion / Partial tear / Complete tear.
The treatment (kinesitherapy, surgery, no intervention) is defined taking into account several factors such as age, knee laxity, physical activity and outcome of the radiology analysis (partial or complete tear). However, if the classification is straightforward in case of complete tear, it is not possible to establish a quantitative impact on the ACL in case of partial tear. As a consequence, the investigators will analyze the anisotropy coefficient with diffusion tractography. Any patient who undergo a posttraumatic knee MRI at the CHU Amiens Picardie will have an appointment at the 3T "Signa" MRI that has the knee-centric diffusion tractography sequence.
- Conditions
- ACL Injury, MRI, Tractography
- Being tested
- tractography MRI sequence protocol
- Keywords
- ACL Injury, MRI, tractography
- 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.
tractography MRI sequence protocolOther
tractography MRI sequence protocol does not require injection of contrast agent.
What is being measured
The primary outcome is the main question the study is designed to answer.
Anisotropy score after tractography MRI sequence
Anisotropy coefficient value is between 0 (isotropic medium) to 1 (fibrillar medium) .
Anisotropy coefficient =0 is for total ACL rupture Anisotropy coefficient between 0 end 0.8 is for partial ACL rupture
Measured: one day
Correlation between anisotropy coefficient and ACL lesion state
Anisotropy coefficient value is between 0 (isotropic medium) to 1 (fibrillar medium) .
Anisotropy coefficient =0 is for total ACL rupture ACL lesion state are No lesion, Partial tear or Complete tear
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start8 Feb 2023
- Primary completion21 Jan 2026
- Study completion21 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806034
- Sponsor's protocol ID
- PI2022_843_0098
- Acronym
- TRACTOLCA
- Status last verified
- Jun 2026
- First submitted
- 28 Mar 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anterior Cruciate Ligament Tears Using Diffusion Tractography
- ClinicalTrials.gov ID
- NCT05806034
- Acronym / sponsor ID
- TRACTOLCA / PI2022_843_0098
- Conditions
- ACL Injury, MRI, Tractography
- Keywords
- ACL Injury, MRI, tractography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 21 Jan 2026 (actual)
- Study completion
- 21 Jan 2026 (actual)
- First posted
- 10 Apr 2023 (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.
Knees injuries commonly affect the ACL. French current methodology is based on MRI focused on the knee with morphological sequences (T1, DP fat sat) allowing the study of ACL as follows: No lesion / Partial tear / Complete tear.
The treatment (kinesitherapy, surgery, no intervention) is defined taking into account several factors such as age, knee laxity, physical activity and outcome of the radiology analysis (partial or complete tear). However, if the classification is straightforward in case of complete tear, it is not possible to establish a quantitative impact on the ACL in case of partial tear. As a consequence, the investigators will analyze the anisotropy coefficient with diffusion tractography. Any patient who undergo a posttraumatic knee MRI at the CHU Amiens Picardie will have an appointment at the 3T "Signa" MRI that has the knee-centric diffusion tractography sequence.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old,
- Patient referred for non-enhanced knee MRI for traumatism.
- Affiliation to a social security program,
Key exclusion criteria (2 listed)
- Person under guardianship or curators,
- Any contraindications to MRI
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 |
|---|---|---|
| tractography MRI sequence protocoltractography MRI sequence protocol does not require injection of contrast agent. | Other | – |
Primary outcome
Anisotropy score after tractography MRI sequence
Time frame: one day
Anisotropy coefficient value is between 0 (isotropic medium) to 1 (fibrillar medium) . Anisotropy coefficient =0 is for total ACL rupture Anisotropy coefficient between 0 end 0.8 is for partial ACL rupture
Correlation between anisotropy coefficient and ACL lesion state
Time frame: one year
Anisotropy coefficient value is between 0 (isotropic medium) to 1 (fibrillar medium) . Anisotropy coefficient =0 is for total ACL rupture ACL lesion state are No lesion, Partial tear or Complete tear
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tractography MRI sequence protocol in people with ACL Injury and MRI, run by Centre Hospitalier Universitaire, Amiens 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 11 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anisotropy score after tractography MRI sequence (time frame: one day). The study lists 2 primary outcomes in all. 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 11 Jun 2026.