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

Knee Ligament Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06024850
• Other study ID #: IRBN342022/CHUSTE
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: March 2025

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Thomas NERI, MD PhD
• Phone: (0)477127549
• Email: Thomas.Neri[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. A clinical and functional follow up will be performed before the surgery, then at 6 months and one year.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Refusal

Related Conditions & MeSH terms

• Knee Ligament Injury

Intervention

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

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

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