Ligament Plastic SurgeryLIGANALYSNCT04361201
Analysis of the Ligamentization Process in the Anatomical Ligamentoplasty of the Lateral Ankle Plane to the Hamstrings
An observational study of Ligament Plastic Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This is a prospective bi-centric study, which evaluate the evolution of RMI signal of transplant till 12 months after ligament plasty surgery. As the primary objective, the study aims to define the post-operative timeframe needed to obtain an optimal quality of repair, especially in their restarting of sportive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ligament Plastic Surgery
- What is being tested?
- Ligament plastic surgery and RMI and ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2021to 30 Mar 2022
- Phase
- Observational
- 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
Study population: Patients underwent a ligament plastic surgery of lateral ankle plane under arthroscopy.
Who may be able to join
- Patient treated priorly by ligament plastic surgery of lateral ankle plane under arthroscopy;
- Affiliated to or covered by the French social security - welfare system in France;
- Have provided written informed consent for the study;
- Be >/= 18 years of age on day of signing informed consent.
Who cannot join
- Patients who undergo iterative surgery or have history of contralateral surgery;
- Patient under guardianship or curatorship;
- Unable to understand the proposed study or provide written informed consent for the study;
- Foreign patients under AME schema, a medical help from the state in France;
- Pregnant or breastfeeding woman;
- Patient refusal.
Trial locations and contacts
1 site in 1 country.
France1 site
Orthopaedic Surgery Department, Ambroise Paré hospital, APHP
Boulogne-Billancourt, 92100
About this study
This is a prospective bi-centric study, which evaluate the evolution of RMI signal of transplant till 12 months after ligament plasty surgery.
As the primary objective, the study aims to define the post-operative timeframe needed to obtain an optimal quality of repair, especially in their restarting of sportive activities, by analysis of RMI signal and biomechanic features modifications.
Read more
As secondary objectives, the study aims to:
- study the correlation between the RMI signal of plasty and the Young's modulus;
- study the evolution of RMI of plasty at M3, M6 and M12;
- study the evolution of Young's modulus at M3, M6 and M12;
- evaluate the reproductibility between 2 lector of RMI measurements;
- evaluate the reproductibility between 2 lector of elastography measurements of LTFA;
- evaluate the optimal delay of return to sport after ligament plasty surgery of ankle;
- develope a score of type SNQ for ankle ligament plasty surgery;
- evolution of AOFAS and EVA scores.
Read the detailed description
The eligible patients will be enrolled in the department of orthopaedic surgery of Ambroise Paré hospital, each patient will undergo a 12-months follow-up in the department of orthopaedic surgery in Armand Trousseau hospital for the elastography evaluations.
- Conditions
- Ligament Plastic Surgery
- Being tested
- Ligament plastic surgery, RMI and ultrasound
- Keywords
- ligament injury, ligamentization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ligament plastic surgeryProcedure or surgery
Ligament plastic surgery of ankle under arthroscopy for recurrent instable ankle reason and failure of medical treatment.
RMI and ultrasoundDiagnostic test
RMI examination at 3 months on operated ankle, and 3 CT scan examinations with elastography module will be performed at planned timeframes.
| Study group | Role | What they receive |
|---|---|---|
| Ligament plastic surgery ankle | Patient treated priorly by ligament plastic surgery of lateral ankle plane under arthroscopy Receives: Procedure: Ligament plastic surgery; Diagnostic Test: RMI and ultrasound | |
| Control group | Controlateral ankle Receives: Procedure: Ligament plastic surgery; Diagnostic Test: RMI and ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification of RMI signal
The classification of RMI signal will be defined as:
- frank hyposignal: stage 1;
- intermediary signal (close to muscles of T2): stage 2;
- moderate hypersignal (close to cartilage of T2): stage 3;
- intensive hypersignal (close tointra-articular liquid of T2): stage 4.
Measured: At 3 months
Classification of RMI signal
The classification of RMI signal will be defined as:
- frank hyposignal: stage 1;
- intermediary signal (close to muscles of T2): stage 2;
- moderate hypersignal (close to cartilage of T2): stage 3;
- intensive hypersignal (close tointra-articular liquid of T2): stage 4.
Measured: At 6 months
Classification of RMI signal
The classification of RMI signal will be defined as:
- frank hyposignal: stage 1;
- intermediary signal (close to muscles of T2): stage 2;
- moderate hypersignal (close to cartilage of T2): stage 3;
- intensive hypersignal (close tointra-articular liquid of T2): stage 4.
Measured: At 12 months
Secondary outcomes (5)
Anterior talofibular ligament measurement
anterior talofibular ligament measurement will be performed by RMI
Measured: At 3, 6 and 12 months
Calcaneofibular ligament measurement
calcaneofibular ligament measurement will be performed by RMI
Measured: At 3, 6 and 12 months
Elastography
Elastography measurements: Young's Modulu
Measured: At 3, 6 and 12 months
Pain evaluation
By the American Orthopedic Foot and Ankle Score (AOFAS) to evaluate the pain.
Measured: At baseline and 3, 6 and 12 months
Pain evaluation
By the visual analog scale (VAS) to evaluate the pain.
Measured: At baseline and 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Feb 2021
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Why it stopped: Physician investigator has decided to terminate the study becasuse he has left APHP hospital.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ligament Plastic SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre HARDY, MD, Principal investigator, Orthopaedic Surgery Department, Ambroise Paré hospital, APHPThomas BAUER, MD, Study director, Orthopaedic Surgery Department, Ambroise Paré hospital, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361201
- Sponsor's protocol ID
- APHP200788
- Other IDs
- 2020-A01317-32
- Acronym
- LIGANALYS
- Status last verified
- Jul 2026
- First submitted
- 20 Apr 2020
- Last updated
- 16 Jul 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Ligamentization Process in the Anatomical Ligamentoplasty of the Lateral Ankle Plane to the Hamstrings
- ClinicalTrials.gov ID
- NCT04361201
- Acronym / sponsor ID
- LIGANALYS / APHP200788
- Conditions
- Ligament Plastic Surgery
- Keywords
- ligament injury, ligamentization
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Physician investigator has decided to terminate the study becasuse he has left APHP hospital.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 24 Apr 2020 (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.
This is a prospective bi-centric study, which evaluate the evolution of RMI signal of transplant till 12 months after ligament plasty surgery.
As the primary objective, the study aims to define the post-operative timeframe needed to obtain an optimal quality of repair, especially in their restarting of sportive activities, by analysis of RMI signal and biomechanic features modifications.
As secondary objectives, the study aims to:
- study the correlation between the RMI signal of plasty and the Young's modulus;
- study the evolution of RMI of plasty at M3, M6 and M12;
- study the evolution of Young's modulus at M3, M6 and M12;
- evaluate the reproductibility between 2 lector of RMI measurements;
- evaluate the reproductibility between 2 lector of elastography measurements of LTFA;
- evaluate the optimal delay of return to sport after ligament plasty surgery of ankle;
- develope a score of type SNQ for ankle ligament plasty surgery;
- evolution of AOFAS and EVA scores.
Detailed description
The eligible patients will be enrolled in the department of orthopaedic surgery of Ambroise Paré hospital, each patient will undergo a 12-months follow-up in the department of orthopaedic surgery in Armand Trousseau hospital for the elastography evaluations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ligament plastic surgery ankle | – | Procedure: Ligament plastic surgery, Diagnostic Test: RMI and ultrasoundPatient treated priorly by ligament plastic surgery of lateral ankle plane under arthroscopy |
| Control group | – | Procedure: Ligament plastic surgery, Diagnostic Test: RMI and ultrasoundControlateral ankle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent a ligament plastic surgery of lateral ankle plane under arthroscopy.
Key inclusion criteria (4 listed)
- Patient treated priorly by ligament plastic surgery of lateral ankle plane under arthroscopy;
- Affiliated to or covered by the French social security - welfare system in France;
- Have provided written informed consent for the study;
- Be >/= 18 years of age on day of signing informed consent.
Key exclusion criteria (6 listed)
- Patients who undergo iterative surgery or have history of contralateral surgery;
- Patient under guardianship or curatorship;
- Unable to understand the proposed study or provide written informed consent for the study;
- Foreign patients under AME schema, a medical help from the state in France;
- Pregnant or breastfeeding woman;
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 |
|---|---|---|
| Ligament plastic surgeryLigament plastic surgery of ankle under arthroscopy for recurrent instable ankle reason and failure of medical treatment. | Procedure or surgery | Control group, Ligament plastic surgery ankle |
| RMI and ultrasoundRMI examination at 3 months on operated ankle, and 3 CT scan examinations with elastography module will be performed at planned timeframes. | Diagnostic test | Control group, Ligament plastic surgery ankle |
Primary outcome
Classification of RMI signal
Time frame: At 3 months
The classification of RMI signal will be defined as: * frank hyposignal: stage 1; * intermediary signal (close to muscles of T2): stage 2; * moderate hypersignal (close to cartilage of T2): stage 3; * intensive hypersignal (close tointra-articular liquid of T2): stage 4.
Classification of RMI signal
Time frame: At 6 months
The classification of RMI signal will be defined as: * frank hyposignal: stage 1; * intermediary signal (close to muscles of T2): stage 2; * moderate hypersignal (close to cartilage of T2): stage 3; * intensive hypersignal (close tointra-articular liquid of T2): stage 4.
Classification of RMI signal
Time frame: At 12 months
The classification of RMI signal will be defined as: * frank hyposignal: stage 1; * intermediary signal (close to muscles of T2): stage 2; * moderate hypersignal (close to cartilage of T2): stage 3; * intensive hypersignal (close tointra-articular liquid of T2): stage 4.
5 secondary outcomes
Anterior talofibular ligament measurement
Time frame: At 3, 6 and 12 months
Calcaneofibular ligament measurement
Time frame: At 3, 6 and 12 months
Elastography
Time frame: At 3, 6 and 12 months
Pain evaluation
Time frame: At baseline and 3, 6 and 12 months
Pain evaluation
Time frame: At baseline and 3, 6 and 12 months
Results and safety
The study was stopped early (reason given: Physician investigator has decided to terminate the study becasuse he has left APHP hospital.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Ligament Plastic Surgery
Not yet recruiting
Evaluation of the Evolution of Proprioceptive Reweighting Abilities Following Anterior Cruciate Ligament Reconstruction Surgery
Anterior Cruciate Ligament Rupture With Ligamentoplasty
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.
Alexandre HARDY, MD principal investigator
Orthopaedic Surgery Department, Ambroise Paré hospital, APHP
Thomas BAUER, MD study director
Orthopaedic Surgery Department, Ambroise Paré hospital, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ligament Plastic Surgery, run by Assistance Publique - Hôpitaux de Paris 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 6 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: stopped early, as of the sponsor's last update on 16 Jul 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 was stopped early (reason given: Physician investigator has decided to terminate the study becasuse he has left APHP hospital.). Results are not available in the source record.
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?
Classification of RMI signal (time frame: At 3 months). The study lists 3 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 16 Jul 2026.