Evaluations, Diagnostic SelfNCT04953455
Translation and Verification of English Lysholm Knee Scoring Scale
An observational study of Evaluations, Diagnostic Self, run by Peking University Third Hospital at 1 site in China.
Trial summary
Through the translation and verification of the Lysholm Knee Score Scale, a Chinese version of the Lysholm Knee Score Scale supported by experimental data was obtained. And on this basis, explore the knee joint score scale that fits the Chinese situation Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Evaluations, Diagnostic Self
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 30 Sep 2017
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Through the diagnosis of MRI and clinicians, patients who are determined to be ligament rupture, patella dislocation, meniscus injury or total knee replacement surgery before and after surgery, the patient should have the ability to read or communicate with others normally, and the age range is 18-80 years old .
Who may be able to join
- Patients with ruptured ligaments, dislocation of the patella, meniscus injury or total knee replacement before and after surgery, and have the ability to read or communicate with others normally.
Who cannot join
- Patients with other injuries to the joints of the lower limbs, or patients who do not have the ability to read or communicate with others normally.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking university third hospital
Beijing, Beijing Municipality, 100191
About this study
Through the translation and verification of the Lysholm Knee Score Scale, a Chinese version of the Lysholm Knee Score Scale supported by experimental data was obtained. And on this basis, explore the knee joint score scale that fits the Chinese situation
Read the detailed description
Lysholm Knee Scoring Scale needs to be translated and back translated into Chinese version of Lysholm Knee Scoring Scale. Through data collection and analysis, the reliability, validity and sensitivity of the Chinese version of the Lysholm Knee Score Scale were studied, and on this basis, the advantages and disadvantages of the scale were analyzed, and a new knee score scale was developed based on the domestic situation.
- Conditions
- Evaluations, Diagnostic Self
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| pre-operation | Within one month before operation of diagnoses with a ligament rupture, patella dislocation, meniscus injury, or total knee replacement surgery Receives: Other: no intervention | |
| early after operation | Within three months after operation of ligament rupture, patella dislocation, meniscus injury, or total knee replacement surgery Receives: Other: no intervention | |
| lately after operation | within three months to one year after operation of ligament rupture, patella dislocation, meniscus injury, or total knee replacement Receives: Other: no intervention | |
| healthy volunteers | Healthy people without abnormalities Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese version of Lysholm Knee Score Scale
Chinese version of Lysholm Knee Score Scale
Measured: 1 year after operation
IKDC Knee Joint Score Scale
IKDC Knee Joint Score Scale
Measured: 1 year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Apr 2017
- Primary completion11 Apr 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluations, Diagnostic SelfStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yingfang ao, M.D., Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953455
- Sponsor's protocol ID
- M2016001
- Status last verified
- Jul 2021
- First submitted
- 28 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Verification of English Lysholm Knee Scoring Scale
- ClinicalTrials.gov ID
- NCT04953455
- Acronym / sponsor ID
- M2016001
- Conditions
- Evaluations, Diagnostic Self
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 11 Apr 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 8 Jul 2021 (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.
Through the translation and verification of the Lysholm Knee Score Scale, a Chinese version of the Lysholm Knee Score Scale supported by experimental data was obtained. And on this basis, explore the knee joint score scale that fits the Chinese situation
Detailed description
Lysholm Knee Scoring Scale needs to be translated and back translated into Chinese version of Lysholm Knee Scoring Scale. Through data collection and analysis, the reliability, validity and sensitivity of the Chinese version of the Lysholm Knee Score Scale were studied, and on this basis, the advantages and disadvantages of the scale were analyzed, and a new knee score scale was developed based on the domestic situation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| pre-operation | – | Other: no interventionWithin one month before operation of diagnoses with a ligament rupture, patella dislocation, meniscus injury, or total knee replacement surgery |
| early after operation | – | Other: no interventionWithin three months after operation of ligament rupture, patella dislocation, meniscus injury, or total knee replacement surgery |
| lately after operation | – | Other: no interventionwithin three months to one year after operation of ligament rupture, patella dislocation, meniscus injury, or total knee replacement |
| healthy volunteers | – | Other: no interventionHealthy people without abnormalities |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Through the diagnosis of MRI and clinicians, patients who are determined to be ligament rupture, patella dislocation, meniscus injury or total knee replacement surgery before and after surgery, the patient should have the ability to read or communicate with others normally, and the age range is 18-80 years old .
Key inclusion criteria (1 listed)
- Patients with ruptured ligaments, dislocation of the patella, meniscus injury or total knee replacement before and after surgery, and have the ability to read or communicate with others normally.
Key exclusion criteria (1 listed)
- Patients with other injuries to the joints of the lower limbs, or patients who do not have the ability to read or communicate with others normally.
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 |
|---|---|---|
| no interventionno intervention | Other | early after operation, healthy volunteers, lately after operation, pre-operation |
Primary outcome
Chinese version of Lysholm Knee Score Scale
Time frame: 1 year after operation
Chinese version of Lysholm Knee Score Scale
IKDC Knee Joint Score Scale
Time frame: 1 year after operation
IKDC Knee Joint Score Scale
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 8 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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.
yingfang ao, M.D. study chair
Peking University Third Hospital
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 Evaluations, Diagnostic Self, run by Peking University Third Hospital at 1 site in China.
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 1 inclusion and 1 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 8 Jul 2021. 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 China. 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?
Chinese version of Lysholm Knee Score Scale (time frame: 1 year after operation). The study lists 2 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 8 Jul 2021.