NCT04653272

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

1.8 years

First QC Date

November 3, 2020

Last Update Submit

January 2, 2023

Conditions

Knee Injuries

Outcome Measures

Primary Outcomes (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.

    Base line

  • 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

  • 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

  • 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 Outcomes (7)

  • SKV reproducibility

    Base line

  • SKV reproducibility

    6 months

  • SKV sensitivity

    Base line

  • SKV sensitivity

    6 months

  • SKV quality

    base line

  • +2 more secondary outcomes

Study Arms (2)

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

QuestionnaireOTHER

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).

ControlExperimental

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • For the patients:
  • Patients aged 16 to 40 years with ligament rupture anterior cruciate ACL, meniscal lesion, instability or anterior patella dislocation ("young" adult group),
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etienne Cavaignac

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Knee Injuries

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Etienne CAVAIGNAC, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2020

First Posted

December 4, 2020

Study Start

April 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 4, 2023

Record last verified: 2023-01

Locations

FR(1)