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

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: Knee Ligament Injury
• Intervention / Treatment: Other: Datas collected

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

• Study Contact: Name: Thomas NERI, MD PhD; Phone Number: +33 (0)477127549; Email: Thomas.Neri@chu-st-etienne.fr
• 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-Etienne
    • Principal Investigator: Thomas NERI, MD PhD
    • Sub-Investigator: Pierre-Henri VERMOREL, resident

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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)	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)	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	Analysis of the Visual Analogue Scale (VAS) scale (from 0 to 10, 10 = pain ++)	Months: 0, 6 and 12
Laxity	Laxity assessed by Magnetic Resonance Imaging (MRI)	Month : 12
Joint amplitudes	Joint amplitudes assessed by the iso-cinetic test	Months: 0, 6 and 12
Clinical data	Data collected at inclusion	Month : 0
Recovery of muscle function	Recovery of muscle function measured by iso kinetic muscle assessment	Month : 12

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Thomas NERI, MD PhD, CHU Saint-Etienne

Study record dates

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: knee; injury; magnetic resonance imaging (MRI); Multiligamentar; knee reconstruction; knee dislocation
• 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