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CompletedNCT04653272SKVUpdated Jan 4, 2023

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

An observational study in Knee Injuries, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-01-04.

Sponsored by University Hospital, Toulouse · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
150
Ages
16 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed 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

02

Conditions studied

  • Knee Injuries

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03

In context

Knee Injuries

249 studies on the registry are indexed under Knee Injuries; 48 are open to participants now.

This study's enrollment of 150 is above the median of 90 across 79 observational studies indexed under Knee Injuries.

Browse Knee Injuries studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 70 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients aged 16 to 40 years with ligament rupture anterior cruciate ACL, meniscal lesion, instability or anterior patella dislocation ("young" adult group), and patients over 55 years of age with gonarthrosis. ("Senior" adults group).

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No

Groups and cohorts

  • Experimental

    * Patients aged 16 to 40 years with ACL anterior cruciate ligament rupture, meniscal injury, patella instability or dislocation (Young Adult group), * Patients over 55 years of age with gonarthrosis ("Senior" adults group).

    Other: Questionnaire

  • Control

    * a group of "young" (16 to 40 years old) * "senior" (over 55 years old) adult controls * Everybody free of knee pathology.

    Other: Questionnaire

Interventions

  • OtherQuestionnaire

    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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Base line

  2. 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.

    Time frame: 2 weeks

  3. 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.

    Time frame: 2 months

  4. 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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: Base line

  2. 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.

    Time frame: 6 months

  3. 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.

    Time frame: Base line

  4. 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.

    Time frame: 6 months

  5. 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.

    Time frame: base line

  6. 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.

    Time frame: 2 weeks

  7. 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.

    Time frame: 2 months

07

Study locations

1 site
  • Etienne Cavaignac
    Toulouse, 31000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04653272
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Dec 4, 2020
Start date
Apr 1, 2020
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Jan 4, 2023

Study contacts

Etienne CAVAIGNAC, MD
principal investigator · University Hospital, Toulouse

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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