Knee InjuriesSKVNCT04653272
Simple Knee Value, a Simple Score for Functional Assessment of the Knee
An observational study of Knee Injuries, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Knee Injuries
- What is being tested?
- Questionnaire
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- Child, Adult, Older adult
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).
Who may be able to join
- 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 :
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simple Knee Value, a Simple Score for Functional Assessment of the Knee - Study SKV
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
- Conditions
- Knee Injuries
- Being tested
- Questionnaire
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Questionnaire | |
| Control | * a group of "young" (16 to 40 years old)
* "senior" (over 55 years old) adult controls
* Everybody free of knee pathology. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (7)
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.
Measured: Base line
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.
Measured: 6 months
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.
Measured: Base line
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.
Measured: 6 months
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.
Measured: base line
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.
Measured: 2 weeks
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Apr 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne CAVAIGNAC, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653272
- Sponsor's protocol ID
- RC31/19/0350
- Acronym
- SKV
- Status last verified
- Jan 2023
- First submitted
- 3 Nov 2020
- Last updated
- 4 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simple Knee Value, a Simple Score for Functional Assessment of the Knee - Study SKV
- ClinicalTrials.gov ID
- NCT04653272
- Acronym / sponsor ID
- SKV / RC31/19/0350
- Conditions
- Knee Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Other: Questionnaire* 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). |
| Control | – | Other: Questionnaire* a group of "young" (16 to 40 years old) * "senior" (over 55 years old) adult controls * Everybody free of knee pathology. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (9 listed)
- 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).
- 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.
- Understanding French
- Having given its non-opposition and for minors having obtained the non-opposition of one of the holders of parental authority
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairePatients 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). | Other | Control, Experimental |
Primary outcome
SKV and score
Time frame: Base line
The analysis of the correlations between the SKV and the validated Functional Scores is based on the calculation of Spearman correlation coefficients.
SKV and score
Time frame: 2 weeks
The analysis of the correlations between the SKV and the validated Functional Scores is based on the calculation of Spearman correlation coefficients.
SKV and score
Time frame: 2 months
The analysis of the correlations between the SKV and the validated Functional Scores is based on the calculation of Spearman correlation coefficients.
SKV and score
Time frame: 6 months
The analysis of the correlations between the SKV and the validated Functional Scores is based on the calculation of Spearman correlation coefficients.
7 secondary outcomes
SKV reproducibility
Time frame: Base line
SKV reproducibility
Time frame: 6 months
SKV sensitivity
Time frame: Base line
SKV sensitivity
Time frame: 6 months
SKV quality
Time frame: base line
SKV quality
Time frame: 2 weeks
SKV quality
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne CAVAIGNAC, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Injuries, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SKV and score (time frame: Base line). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.