Lateral Patellar Compression SyndromeNCT04454593
Novel Method for Diagnosing Lateral Patellar Compression Syndrome Using X-ray: a Retrospective Case-Control Study
An observational study of Lateral Patellar Compression Syndrome, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study evaluates whether the patellar axial radiograph of lateral patellar curvature angle （LPCA）with knee flexion at 30 ° can be used as a new diagnostic surrogate of lateral patellar compression syndrome（LPCS）. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lateral Patellar Compression Syndrome
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2020to 22 May 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We enrolled 87 patients between 2016 and 2019 and divided them as per diagnosis into three groups of 29 each: LPCS, patellar dislocation (PD, control), and meniscus tear (MT, negative control) groups.
Who may be able to join
- Patients were diagnosed as LPCS ，MT and PD respectively
Who cannot join
- patients with ligament injury, malunion of patella fracture, free bodies in the joint, surgical contraindications, and with both knees affected.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
This study evaluates whether the patellar axial radiograph of lateral patellar curvature angle （LPCA）with knee flexion at 30 ° can be used as a new diagnostic surrogate of lateral patellar compression syndrome（LPCS）. We believe that the new index LPCA has high sensitivity and specificity in initial diagnosis of LPCS using axial patellar radiograph with knee flexion at 30 ° , and has high application value.
Read the detailed description
Background: A well-established reference is lacking for diagnosing lateral patellar compression syndrome (LPCS), and this diagnosis currently depends on clinicians' subjective judgment and several examination results. X-rays are primarily used to diagnose LPCS, but they have low detection rates of patellar tilt using the congruence angle (CA) and patellar tilting angle (PTA).
Purpose: To investigate whether patellar axial radiography of the lateral patellar curvature angle (LPCA) of knee in 30° flexion can diagnose LPCS.
Methods: We enrolled 87 patients between 2016 and 2019 and divided them as per diagnosis into three groups of 29 each: LPCS, patellar dislocation (PD, control), and meniscus tear (MT, negative control) groups. A senior radiologist and the chief physician of sports medicine examined their patellar axial radiographs of the knee in 30° flexion using a computer imaging system, measuring LPCA, PTA, and CA. Univariate analysis of variance and Kruskal-Wallis H test were used to compare measurement data with normal distribution and non-normal distribution, respectively. Bonferroni correction was used to analyze different indicators for different groups. The area under the curve (AUC) was calculated to verify the value of LPCA in initial diagnosis of LPCS.
- Conditions
- Lateral Patellar Compression Syndrome
- Being tested
- no intervention
- Keywords
- Lateral patellar compression syndrome, Lateral patellar curvature angle, Patellar axial radiographs, The area under the curve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
This is an observation study,with no intervention
| Study group | Role | What they receive |
|---|---|---|
| Lateral patellar compression syndrome | Patients diagnosed with lateral patellar compression syndrome between February 2016 and April 2019 Receives: Other: no intervention | |
| patellar dislocation | Patients diagnosed with patellar dislocation between February 2016 and April 2019 Receives: Other: no intervention | |
| meniscus tear | Patients diagnosed with meniscus tear between February 2016 and April 2019 Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
lateral patellar curvature angle
lateral patellar curvature angle in three groups was compared
Measured: between 2016 and 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start22 Mar 2020
- Primary completion22 Apr 2020
- Study completion22 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Patellar Compression SyndromeStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yang Yu-ping, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454593
- Sponsor's protocol ID
- M2019464
- Status last verified
- Jun 2020
- First submitted
- 29 Jun 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Method for Diagnosing Lateral Patellar Compression Syndrome Using X-ray: a Retrospective Case-Control Study
- ClinicalTrials.gov ID
- NCT04454593
- Acronym / sponsor ID
- M2019464
- Conditions
- Lateral Patellar Compression Syndrome
- Keywords
- Lateral patellar compression syndrome, Lateral patellar curvature angle, Patellar axial radiographs, The area under the curve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 22 Mar 2020 (actual)
- Primary completion
- 22 Apr 2020 (actual)
- Study completion
- 22 May 2020 (actual)
- First posted
- 1 Jul 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.
This study evaluates whether the patellar axial radiograph of lateral patellar curvature angle （LPCA）with knee flexion at 30 ° can be used as a new diagnostic surrogate of lateral patellar compression syndrome（LPCS）. We believe that the new index LPCA has high sensitivity and specificity in initial diagnosis of LPCS using axial patellar radiograph with knee flexion at 30 ° , and has high application value.
Detailed description
Background: A well-established reference is lacking for diagnosing lateral patellar compression syndrome (LPCS), and this diagnosis currently depends on clinicians' subjective judgment and several examination results. X-rays are primarily used to diagnose LPCS, but they have low detection rates of patellar tilt using the congruence angle (CA) and patellar tilting angle (PTA).
Purpose: To investigate whether patellar axial radiography of the lateral patellar curvature angle (LPCA) of knee in 30° flexion can diagnose LPCS.
Methods: We enrolled 87 patients between 2016 and 2019 and divided them as per diagnosis into three groups of 29 each: LPCS, patellar dislocation (PD, control), and meniscus tear (MT, negative control) groups. A senior radiologist and the chief physician of sports medicine examined their patellar axial radiographs of the knee in 30° flexion using a computer imaging system, measuring LPCA, PTA, and CA. Univariate analysis of variance and Kruskal-Wallis H test were used to compare measurement data with normal distribution and non-normal distribution, respectively. Bonferroni correction was used to analyze different indicators for different groups. The area under the curve (AUC) was calculated to verify the value of LPCA in initial diagnosis of LPCS.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lateral patellar compression syndrome | – | Other: no interventionPatients diagnosed with lateral patellar compression syndrome between February 2016 and April 2019 |
| patellar dislocation | – | Other: no interventionPatients diagnosed with patellar dislocation between February 2016 and April 2019 |
| meniscus tear | – | Other: no interventionPatients diagnosed with meniscus tear between February 2016 and April 2019 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We enrolled 87 patients between 2016 and 2019 and divided them as per diagnosis into three groups of 29 each: LPCS, patellar dislocation (PD, control), and meniscus tear (MT, negative control) groups.
Key inclusion criteria (1 listed)
- Patients were diagnosed as LPCS ，MT and PD respectively
Key exclusion criteria (1 listed)
- patients with ligament injury, malunion of patella fracture, free bodies in the joint, surgical contraindications, and with both knees affected.
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 interventionThis is an observation study,with no intervention | Other | Lateral patellar compression syndrome, meniscus tear, patellar dislocation |
Primary outcome
lateral patellar curvature angle
Time frame: between 2016 and 2019
lateral patellar curvature angle in three groups was compared
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 1 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Yang Yu-ping 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 Lateral Patellar Compression Syndrome, 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 1 Jul 2020. 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?
lateral patellar curvature angle (time frame: between 2016 and 2019). 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 1 Jul 2020.