Knee Ligament InjuryNCT06024850
Predictive Factors of Good Results After Multiligamentar Knee Reconstruction (MLKR)
An observational study of Knee Ligament Injury, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Multiligamentar knee injury has consequences on knee function (instability, arthritis, life disagreement). Surgical reconstructions have known recent evolutions. The goal of this study is to evaluate functional and clinical results at one year of those new surgical technics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Ligament Injury
- What is being tested?
- Datas collected
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2022to Mar 2025
- 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: Any patient who benefits of a multiligamentar knee reconstruction at hospital of Saint-Etienne will be included.
Who may be able to join
- Any patient who benefits of a multiligamentar knee reconstruction at hospital of Saint-Etienne
Who cannot join
- Refusal
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Saint-Etienne
Saint-Etienne
Thomas NERI, MD PhD
Pierre-Henri VERMOREL, resident
About this study
Multiligamentar knee injury has consequences on knee function (instability, arthritis, life disagreement). Surgical reconstructions have known recent evolutions. The goal of this study is to evaluate functional and clinical results at one year of those new surgical technics. A clinical and functional follow up will be performed before the surgery, then at 6 months and one year.
Read the detailed description
Patients will also benefit of a Magnetic Resonance Imaging (MRI) and isokinetic evaluations at one year.
- Conditions
- Knee Ligament Injury
- Being tested
- Datas collected
- Keywords
- Multiligamentar, injury, knee, magnetic resonance imaging (MRI), knee reconstruction, knee dislocation
- Medical subject headings
- Wounds and Injuries, Knee Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Datas collectedOther
Datas collected by medical record: medical data (weight, height, smoking status, history) and socio-demographic data (age, occupation, type of injury) information, assessment of knee function before surgery, at 6 months and 1 year after surgery, magnetic resonance imaging (MRI) and radiological imaging at 1 year after surgery, results of the Iso-kinetic Muscle Assessment Test at 1 year after surgery to objectively determine the recovery of muscle function
The data collected will be used to perform a statistical analysis to evaluate the factors predicting a good long-term post-surgical evolution
| Study group | Role | What they receive |
|---|---|---|
| multiligamentar knee reconstruction | Any patient who benefits of a multiligamentar knee reconstruction at hospital of Saint-Etienne will be included.
Datas collected by medical record. Receives: Other: Datas collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional score : International Knee Documentation Committee (IKDC)
The International Knee Documentation Committee (IKDC) is a questionnaire that assigns patients an overall functional score. Three categories are examined by the questionnaire: symptoms, sports activity and knee function, on a scale of 0 to 100.
Measured: Months : 0, 6 and 12
Secondary outcomes (6)
Functional score : Knee Injury and Osteoarthritis Outcome Score (KOOS)
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is used to assess immediate and long-term patient outcomes after knee injury. Five outcomes are assessed by the self-administered KOOS: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life, on a scale of 0 to 100.
Measured: Months : 0, 6 and 12
Visual Analogue Scale (VAS) scale
Analysis of the Visual Analogue Scale (VAS) scale (from 0 to 10, 10 = pain ++)
Measured: Months: 0, 6 and 12
Laxity
Laxity assessed by Magnetic Resonance Imaging (MRI)
Measured: Month : 12
Joint amplitudes
Joint amplitudes assessed by the iso-cinetic test
Measured: Months: 0, 6 and 12
Clinical data
Data collected at inclusion
Measured: Month : 0
Recovery of muscle function
Recovery of muscle function measured by iso kinetic muscle assessment
Measured: Month : 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Feb 2022
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Ligament InjuryStudies 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
- 80 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
- NCT06024850
- Sponsor's protocol ID
- IRBN342022/CHUSTE
- Status last verified
- Sep 2024
- First submitted
- 21 Jul 2023
- Last updated
- 20 Sep 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 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Good Results After Multiligamentar Knee Reconstruction (MLKR)
- ClinicalTrials.gov ID
- NCT06024850
- Acronym / sponsor ID
- IRBN342022/CHUSTE
- Conditions
- Knee Ligament Injury
- Keywords
- Multiligamentar, injury, knee, magnetic resonance imaging (MRI), knee reconstruction, knee dislocation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 6 Sep 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.
Multiligamentar knee injury has consequences on knee function (instability, arthritis, life disagreement). Surgical reconstructions have known recent evolutions. The goal of this study is to evaluate functional and clinical results at one year of those new surgical technics. A clinical and functional follow up will be performed before the surgery, then at 6 months and one year.
Detailed description
Patients will also benefit of a Magnetic Resonance Imaging (MRI) and isokinetic evaluations at one year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| multiligamentar knee reconstruction | – | Other: Datas collectedAny patient who benefits of a multiligamentar knee reconstruction at hospital of Saint-Etienne will be included. Datas 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
- Any patient who benefits of a multiligamentar knee reconstruction at hospital of Saint-Etienne will be included.
Key inclusion criteria (1 listed)
- Any patient who benefits of a multiligamentar knee reconstruction at hospital of Saint-Etienne
Key exclusion criteria (1 listed)
- Refusal
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 collectedDatas collected by medical record: medical data (weight, height, smoking status, history) and socio-demographic data (age, occupation, type of injury) information, assessment of knee function before surgery, at 6 months and 1 year after surgery, magnetic resonance imaging (MRI) and radiological imaging at 1 year after surgery, results of the Iso-kinetic Muscle Assessment Test at 1 year after surgery to objectively determine the recovery of muscle function The data collected will be used to perform a statistical analysis to evaluate the factors predicting a good long-term post-surgical evolution | Other | multiligamentar knee reconstruction |
Primary outcome
Functional score : International Knee Documentation Committee (IKDC)
Time frame: Months : 0, 6 and 12
The International Knee Documentation Committee (IKDC) is a questionnaire that assigns patients an overall functional score. Three categories are examined by the questionnaire: symptoms, sports activity and knee function, on a scale of 0 to 100.
6 secondary outcomes
Functional score : Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Months : 0, 6 and 12
Visual Analogue Scale (VAS) scale
Time frame: Months: 0, 6 and 12
Laxity
Time frame: Month : 12
Joint amplitudes
Time frame: Months: 0, 6 and 12
Clinical data
Time frame: Month : 0
Recovery of muscle function
Time frame: Month : 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 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. This study is not recruiting at the moment.
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 Knee Ligament Injury, 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: status not confirmed, as of the sponsor's last update on 20 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas NERI, MD PhD ((0)477127549 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?
Functional score : International Knee Documentation Committee (IKDC) (time frame: Months : 0, 6 and 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 20 Sep 2024.