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NCT Number: NCT06024850

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.

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Key information

Conditions

Knee Ligament Injury Joint Diseases Joint Dislocations Knee Dislocation Knee Injuries Leg Injuries Musculoskeletal Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint-Etienne

Saint-Etienne, France

Location status: Recruiting

Location contact

Pierre-Henri VERMOREL, resident

SUB_INVESTIGATOR

Thomas NERI, MD PhD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Refusal

Treatment and study plan

Datas collected

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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 ++)

  3. Laxity

    Time frame: Month : 12

    Laxity assessed by Magnetic Resonance Imaging (MRI)

  4. Joint amplitudes

    Time frame: Months: 0, 6 and 12

    Joint amplitudes assessed by the iso-cinetic test

  5. Clinical data

    Time frame: Month : 0

    Data collected at inclusion

  6. Recovery of muscle function

    Time frame: Month : 12

    Recovery of muscle function measured by iso kinetic muscle assessment

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre-Henri VERMOREL, resident

CONTACT

[email protected]

(0)477127549 ext. +33

Thomas NERI, MD PhD

CONTACT

[email protected]

(0)477127549 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 6, 2023
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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