Anterior Cruciate Ligament RuptureNCT06379308
Anterior Cruciate Ligament (ACL) Revision Surgery: French National Study
An observational study of Anterior Cruciate Ligament Rupture, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
This is a national multicentric study led by the French Arthroscopy Society (SFA) evaluating clinical practice in anterior cruciate ligament (ACL) revision surgery (epidemiological data, morphological data, operative data, clinical and functional outcomes, and surgical complication rates). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- questionaries and datas of medical record
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to Apr 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with an anterior cruciate ligament (ACL) revision will be included.
Who may be able to join
- Patient with an anterior cruciate ligament (ACL) revision, defined as "all surgical procedures involving replacement of the anterior cruciate ligament (ACL) graft with a new graft".
Who cannot join
- multil-igament injuries
- any procedure where the ACL was not revised and where any additional graft was inserted
- Patients who had already undergone their first revision anterior cruciate ligament (ACL) procedure
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, 1 recruiting
- Recruiting
CHU Saint-Etienne
Saint-Etienne
Thomas NERI, MD PhD, (0)477120784 ext. +33, thomas.neri@chu-st-etienne.fr
Thomas NERI, MD PhD
About this study
This is a national multicentric study led by the French Arthroscopy Society (SFA) evaluating clinical practice in anterior cruciate ligament (ACL) revision surgery (epidemiological data, morphological data, operative data, clinical and functional outcomes, and surgical complication rates).
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- questionaries, datas of medical record
- Keywords
- Knee, ACL, revision, surgery
- 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.
questionariesOther
Questionaries will be administered :
- Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI)
- Tegner Activity Scale (TAS)
- Simple Knee Value (SKV)
- International Knee Documentation Commitee (IKDC)
datas of medical recordOther
datas of medical record will be collected : epidemiological data, morphological data, operative data, clinical and functional outcomes, and surgical complication.
| Study group | Role | What they receive |
|---|---|---|
| Patient with Anterior Cruciate Ligament (ACL) revision | Patient with Anterior Cruciate Ligament (ACL) revision will be included. Questionary will be administrated and datas will be collected by medical record. Receives: Other: questionaries; Other: datas of medical record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of Functional score questionary Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI)
Results of Functional score questionary Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI) will be analyzed.
questionary Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI) has 12 questions (min = 0, max = 100). Greater psychological preparation is indicated by higher scores.
Measured: Months: 0, 6, 12 and 24
Results of Functional score questionary Tegner Activity Scale (TAS)
Results of Functional score questionary Tegner Activity Scale (TAS) will be analyzed.
The Tegner Activity Scale (TAS) is a scale of sporting and professional physical activities: from 0 (professional disability due to knee) to 10 (competitive sport such as soccer or rugby at national or international level).
Measured: Months: 0, 6, 12 and 24
Results of Functional score questionary Simple Knee Value (SKV)
Results of Functional score questionary Simple Knee Value (SKV) will be analyzed.
Scale from 0 to 100 to evaluate the knee function in daily life (0 is no function and 100 is normal function)
Measured: Months: 0, 6, 12 and 24
Results of Functional score questionary International Knee Documentation Commitee (IKDC)
Results of Functional score questionary Knee Documentation Commitee (IKDC) will be analyzed.
Subjective evaluation of the knee function (from 0 to 100%, 0 is no function and 100 is normal function)
Measured: Months: 0, 6, 12 and 24
Secondary outcomes (1)
Surgical complications
Report of surgical complications during the 2 months following the surgery
Measured: From surgery to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 Jan 2024
- Primary completionApr 2025 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas NERI, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379308
- Sponsor's protocol ID
- IRBN552024/CHUSTE.
- Status last verified
- Jul 2024
- First submitted
- 18 Apr 2024
- Last updated
- 22 Jul 2024
- 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 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Cruciate Ligament (ACL) Revision Surgery: French National Study
- ClinicalTrials.gov ID
- NCT06379308
- Acronym / sponsor ID
- IRBN552024/CHUSTE.
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- Knee, ACL, revision, surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 23 Apr 2024 (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 national multicentric study led by the French Arthroscopy Society (SFA) evaluating clinical practice in anterior cruciate ligament (ACL) revision surgery (epidemiological data, morphological data, operative data, clinical and functional outcomes, and surgical complication rates).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with Anterior Cruciate Ligament (ACL) revision | – | Other: questionaries, Other: datas of medical recordPatient with Anterior Cruciate Ligament (ACL) revision will be included. Questionary will be administrated and datas will be collected by medical record. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with an anterior cruciate ligament (ACL) revision will be included.
Key inclusion criteria (1 listed)
- Patient with an anterior cruciate ligament (ACL) revision, defined as "all surgical procedures involving replacement of the anterior cruciate ligament (ACL) graft with a new graft".
Key exclusion criteria (3 listed)
- multil-igament injuries
- any procedure where the ACL was not revised and where any additional graft was inserted
- Patients who had already undergone their first revision anterior cruciate ligament (ACL) procedure
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 |
|---|---|---|
| questionariesQuestionaries will be administered : * Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI) * Tegner Activity Scale (TAS) * Simple Knee Value (SKV) * International Knee Documentation Commitee (IKDC) | Other | Patient with Anterior Cruciate Ligament (ACL) revision |
| datas of medical recorddatas of medical record will be collected : epidemiological data, morphological data, operative data, clinical and functional outcomes, and surgical complication. | Other | Patient with Anterior Cruciate Ligament (ACL) revision |
Primary outcome
Results of Functional score questionary Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI)
Time frame: Months: 0, 6, 12 and 24
Results of Functional score questionary Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI) will be analyzed. questionary Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI) has 12 questions (min = 0, max = 100). Greater psychological preparation is indicated by higher scores.
Results of Functional score questionary Tegner Activity Scale (TAS)
Time frame: Months: 0, 6, 12 and 24
Results of Functional score questionary Tegner Activity Scale (TAS) will be analyzed. The Tegner Activity Scale (TAS) is a scale of sporting and professional physical activities: from 0 (professional disability due to knee) to 10 (competitive sport such as soccer or rugby at national or international level).
Results of Functional score questionary Simple Knee Value (SKV)
Time frame: Months: 0, 6, 12 and 24
Results of Functional score questionary Simple Knee Value (SKV) will be analyzed. Scale from 0 to 100 to evaluate the knee function in daily life (0 is no function and 100 is normal function)
Results of Functional score questionary International Knee Documentation Commitee (IKDC)
Time frame: Months: 0, 6, 12 and 24
Results of Functional score questionary Knee Documentation Commitee (IKDC) will be analyzed. Subjective evaluation of the knee function (from 0 to 100%, 0 is no function and 100 is normal function)
1 secondary outcome
Surgical complications
Time frame: From surgery to 2 months
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 22 Jul 2024.
- 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.
Thomas NERI, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Anterior Cruciate Ligament Rupture, run by Centre Hospitalier Universitaire de Saint Etienne 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 22 Jul 2024. 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 Thomas NERI, MD PhD ((0)477120784 ext. +33, thomas.neri@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results of Functional score questionary Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI) (time frame: Months: 0, 6, 12 and 24). The study lists 4 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 22 Jul 2024.