Anterior Cruciate Ligament RuptureNCT04781920
Follow-up of Anterior Cruciate Ligament Reconstruction
An observational study of Anterior Cruciate Ligament Rupture, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Rupture of Anterior Cruciate Ligament (ACL) is a common pathology, but is subject to variability of associated lesions, surgical management and rehabilitation. 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?
- datas collection
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to Sep 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: Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction will be included.
Who may be able to join
- Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction
Who cannot join
- None
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
Rémi PHILIPPOT, MD PhD
About this study
Rupture of Anterior Cruciate Ligament (ACL) is a common pathology, but is subject to variability of associated lesions, surgical management and rehabilitation.
Read the detailed description
In this study, a collect data of patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction in order to evaluate the clinical, functional and morphological results of this intervention, in order to improve the management of the patient.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- datas collection
- Keywords
- Anterior Cruciate Ligament, reconstruction, Operative report, Consultation report, Isokinetic tests, Clinical surveys
- 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.
datas collectionOther
data collection in history medical : operative report, clinical examination, questionnaires, imaging, isokinetic tests
| Study group | Role | What they receive |
|---|---|---|
| Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction | Patients having undergone an ACL reconstruction will be included. Receives: Other: datas collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of Magnetic Resonance Imaging (MRI) results
Collected in medical records
Measured: Pre-operative and Month: 12
Secondary outcomes (4)
Analysis of operative report results
Collected in medical records
Measured: Month: 12
Analysis of consultation report
Collected in medical records
Measured: pre-operative and Months: 1,5 , 3, 6, 12
Analysis of isokinetic tests
Collected in medical records
Measured: Months: 9, 12
Analysis of clinical surveys
Collected in medical records
Measured: pre-operative and Months: 3, 6, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Mar 2021
- Primary completionSep 2025 (estimated)
- Study completionSep 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
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas NERI, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781920
- Sponsor's protocol ID
- IRBN162021/CHUSTE
- Status last verified
- Aug 2024
- First submitted
- 25 Feb 2021
- Last updated
- 29 Aug 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 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT04781920
- Acronym / sponsor ID
- IRBN162021/CHUSTE
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- Anterior Cruciate Ligament, reconstruction, Operative report, Consultation report, Isokinetic tests, Clinical surveys
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 4 Mar 2021 (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.
Rupture of Anterior Cruciate Ligament (ACL) is a common pathology, but is subject to variability of associated lesions, surgical management and rehabilitation.
Detailed description
In this study, a collect data of patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction in order to evaluate the clinical, functional and morphological results of this intervention, in order to improve the management of the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction | – | Other: datas collectionPatients having undergone an ACL reconstruction will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction will be included.
Key inclusion criteria (1 listed)
- Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| datas collectiondata collection in history medical : operative report, clinical examination, questionnaires, imaging, isokinetic tests | Other | Patients having undergone an Anterior Cruciate Ligament (ACL) reconstruction |
Primary outcome
Analysis of Magnetic Resonance Imaging (MRI) results
Time frame: Pre-operative and Month: 12
Collected in medical records
4 secondary outcomes
Analysis of operative report results
Time frame: Month: 12
Analysis of consultation report
Time frame: pre-operative and Months: 1,5 , 3, 6, 12
Analysis of isokinetic tests
Time frame: Months: 9, 12
Analysis of clinical surveys
Time frame: pre-operative and Months: 3, 6, 12
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 29 Aug 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 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 1 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 29 Aug 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 ((0)477127849 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?
Analysis of Magnetic Resonance Imaging (MRI) results (time frame: Pre-operative and Month: 12). 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 29 Aug 2024.