Predictive Factors of Good Results After Multiligamentar Knee Reconstruction (MLKR)

September 19, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients will also benefit of a Magnetic Resonance Imaging (MRI) and isokinetic evaluations at one year.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Pierre-Henri VERMOREL, resident
  • Phone Number: +33 (0)477127549
  • Email: vermoph@hotmail.fr

Study Locations

  • France
      • Saint-Étienne, France
        • Recruiting
        • CHU Saint-étienne
        • Principal Investigator:
          • Thomas NERI, MD PhD
        • Sub-Investigator:
          • Pierre-Henri VERMOREL, resident

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Any patient who benefits of a multiligamentar knee reconstruction at hospital of Saint-Etienne will be included.

Description

Inclusion Criteria:

  • Any patient who benefits of a multiligamentar knee reconstruction at hospital of Saint-Etienne

Exclusion Criteria:

  • Refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Datas collected

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Months : 0, 6 and 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional score : Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Months : 0, 6 and 12
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.
Months : 0, 6 and 12
Visual Analogue Scale (VAS) scale
Time Frame: Months: 0, 6 and 12
Analysis of the Visual Analogue Scale (VAS) scale (from 0 to 10, 10 = pain ++)
Months: 0, 6 and 12
Laxity
Time Frame: Month : 12
Laxity assessed by Magnetic Resonance Imaging (MRI)
Month : 12
Joint amplitudes
Time Frame: Months: 0, 6 and 12
Joint amplitudes assessed by the iso-cinetic test
Months: 0, 6 and 12
Clinical data
Time Frame: Month : 0
Data collected at inclusion
Month : 0
Recovery of muscle function
Time Frame: Month : 12
Recovery of muscle function measured by iso kinetic muscle assessment
Month : 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Thomas NERI, MD PhD, CHU Saint-étienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

September 6, 2023

Study Record Updates

Last Update Posted (Actual)

September 20, 2024

Last Update Submitted That Met QC Criteria

September 19, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRBN342022/CHUSTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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