Simple Knee Value, a Simple Score for Functional Assessment of the Knee

Knee Injuries Clinical Trial

— SKV  

Official title:

Simple Knee Value, a Simple Score for Functional Assessment of the Knee - Study SKV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04653272
• Other study ID #: RC31/19/0350
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The pre- and post-operative functional assessment of patients' knees is of great interest for the practitioner, whether it is in his or her daily practice to determine the appropriate management of the patient, or to conduct clinical studies. The scores used are established in several languages to provide a uniformly accepted unit of measurement.

Description:

The pre- and post-operative functional assessment of patients' knees is of great interest for the practitioner, whether it is in his or her daily practice to determine the appropriate management of the patient, or to conduct clinical studies. The scores used are established in several languages to provide a uniformly accepted unit of measurement.

A large number of functional knee scores already exist. These include scores for Lysholm-Tegner, International Knee Documentation Committee (IKDC) and Knee injury and Osteoarthritis Outcome Score (KOOS), but these can be difficult to apply in practice. daily due to their length, which may be too time-consuming for the clinician when consultations for example.

Shoulder surgeons are familiar with the Simple Shoulder Value (SSV) score, which simply consists of asking the patient how much they value their shoulder on the day of the exam, compared to a normal shoulder in percentage terms. It has been shown to produce results that are close to Constant score or Rowe and American Shoulder Score and Elbow score Surgeons Score after shoulder surgery. It is, since its description, very much used in daily practice by shoulder surgeons because of its speed and simplicity of execution.

No such assessment exists to our knowledge for the knee. The validation of a score of this type for the knee joint would allow the use of a new practical tool for a better patient management while saving the practitioner and the patient money. time in consultation.

The investigators would like to propose a functional knee score similar to the ISS for the shoulder that would allow a self-assessment of the condition of a knee, compared to a normal knee in percentage terms.

The hypothesis is that the SKV (Simple Knee Value) is a valid score giving results of equivalent to the various scores already used in the functional assessment of the knee in the different pathological situations in adult and paediatric populations

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

For the patients:

1. Patients aged 16 to 40 years with ligament rupture anterior cruciate ACL, meniscal lesion, instability or anterior patella dislocation ("young" adult group),

2. Patients over 55 years of age with gonarthrosis. ("Senior" adults group).

For the controls:

In order to test the discriminating qualities of the SKV score, a group young" (16 to 40 years old) and "senior" (16 to 40 years old) adult witnesses, and 55 years old) with no problems with one of their knees.

For all participants :

• Understanding French

• Having given its non-opposition and for minors having obtained the non-opposition of one of the holders of parental authority

• Affiliation to a social security scheme

Exclusion Criteria:

For all participants :

• Memory disorders,

• Psychiatric disorders,

• Patient refusal to participate in the study,

• Patient under the protection of adults (guardianship, guardianship, safeguarding of justice),

• Pregnant and/or breastfeeding woman

Related Conditions & MeSH terms

• Knee Injuries

Intervention

Other:
• Questionnaire
Patients will be evaluated identically to routine care with reference tests (Lysholm-Tegner, and Knee injury and Osteoarthritis Outcome Score (KOSS) and, IKDC (Evaluation of knee ligament injuries). This is filled in without any external help. The questionnaire includes the Lysholm-Tegner (young adult group), IKDC and KOOS scores (young and senior adult groups).

Locations

Country	Name	City	State
France	Etienne Cavaignac	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SKV and score	The analysis of the correlations between the SKV and the validated Functional Scores is based on the calculation of Spearman correlation coefficients.	Base line
Primary	SKV and score	The analysis of the correlations between the SKV and the validated Functional Scores is based on the calculation of Spearman correlation coefficients.	2 weeks
Primary	SKV and score	The analysis of the correlations between the SKV and the validated Functional Scores is based on the calculation of Spearman correlation coefficients.	2 months
Primary	SKV and score	The analysis of the correlations between the SKV and the validated Functional Scores is based on the calculation of Spearman correlation coefficients.	6 months
Secondary	SKV reproducibility	The analysis of the reproducibility of the SKV score is based on the calculation of intraclass correlation coefficients in order to evaluate the concordance between the SKV score at inclusion and preoperatively in patients with a surgical indication.	Base line
Secondary	SKV reproducibility	The analysis of the reproducibility of the SKV score is based on the calculation of intraclass correlation coefficients in order to evaluate the concordance between the SKV score at inclusion and preoperatively in patients with a surgical indication.	6 months
Secondary	SKV sensitivity	The analysis of the sensitivity to change in the SKV score is based on paired serial comparison tests (Wilcoxon test) of the SKV score at baseline and at 6 months postoperative follow-up in patients with a surgical indication.	Base line
Secondary	SKV sensitivity	The analysis of the sensitivity to change in the SKV score is based on paired serial comparison tests (Wilcoxon test) of the SKV score at baseline and at 6 months postoperative follow-up in patients with a surgical indication.	6 months
Secondary	SKV quality	The analysis of the discriminating qualities of the SKV score (and other functional scores) is based on a comparison of the distribution of the SKV score (and other functional scores) measured at inclusion in adult patients and adult controls.	base line
Secondary	SKV quality	The analysis of the discriminating qualities of the SKV score (and other functional scores) is based on a comparison of the distribution of the SKV score (and other functional scores) measured at inclusion in adult patients and adult controls.	2 weeks
Secondary	SKV quality	The analysis of the discriminating qualities of the SKV score (and other functional scores) is based on a comparison of the distribution of the SKV score (and other functional scores) measured at inclusion in adult patients and adult controls.	2 months