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

NCT06024850 | Recruiting

• 1 other identifier: IRBN342022/CHUSTE
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Ligament Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Functional score : Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Months : 0, 6 and 12

• Visual Analogue Scale (VAS) scale

  Months: 0, 6 and 12

• Laxity

  Month : 12

• Joint amplitudes

  Months: 0, 6 and 12

• Clinical data

  Month : 0

Study Arms (1)

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

Interventions

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

multiligamentar knee reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Refusal

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Knee Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Knee Injuries; Leg Injuries

Study Officials

• Thomas NERI, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas NERI, MD PhD

CONTACT

(0)477127549; Thomas.Neri@chu-st-etienne.fr

Pierre-Henri VERMOREL, resident

CONTACT

(0)477127549; vermoph@hotmail.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: September 6, 2023
• Study Start: February 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)