- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03450824
Relationship Between Constitutional Varus Knee and Patellofemoral Pain
June 28, 2023 updated by: 113th Hospital of Chinese People's Liberation Army
Research on the Relationship Between Constitutional Varus Knee and Patellofemoral Pain
This study aims to research on the relationship between constitutional varus knee and patellofemoral pain.
The standardized standing whole-lower-extremity radiographs, the knee lateral view and skyline view of the participants will be taken.
The hip-knee-ankle angle will be obtained from the radiographs.
According to the hip-knee-ankle angle, the knees will be labelled knee varus or knee nonvarus.
The knee varus incidences of the two groups will be determined and compared.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The patellofemoral joint will be assessed in the skyline view and lateral view.
The hip-knee-ankle angle will be obtained from the standing whole-lower-extremity radiographs.
According to the hip-knee-ankle angle, the knees will be labelled knee varus or knee nonvarus.
The knee varus incidences of the two groups will be determined and compared.
It is hypothesized that constitutional varus knee is a risk factor for patellofemoral pain.
Study Type
Observational
Enrollment (Actual)
21
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Zhejiang
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Ningbo, Zhejiang, China, 315040
- Orthopaedics clinic, No.113 Hospital of Chinese People's Liberation Army
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Military personnel.
Running at least 10 km per week for at least 3 months.
Description
Inclusion Criteria:
- Patellofemoral pain during physical activities such as running, jumping, squatting, and going up or down stairs for at least 4 weeks.
- The onset of pain is required to be atraumatic in nature.
- Exhibit two of the following clinical criteria on assessment: pain on direct compression of the patella against the femoral condyles with the knee in full extension, tenderness of the posterior surface of the patell on palpation, pain on resisted knee extension, and pain with isometric quadriceps muscle contraction against suprapatellar resistance with the knee in 15° of flexion.
- Negative findings in the examination of knee ligaments, menisci, bursae, synovial plicae, Hoffa's fat pad, iliotibial band, and the hamstring, quadriceps, and patellar tendons and their insertions.
Exclusion Criteria:
- With patellofemoral instability, or With other knee diagnoses.
- Any previous surgery or severe trauma in the affected limb.
- Inflammatory joint disease or tumors in the affected limb.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
The study group
The participants with patellofemoral pain.
|
The standardized standing whole-lower-extremity radiographs, the knee lateral view and skyline view of the participants will be taken.
|
The control group
The participants without patellofemoral pain.
|
The standardized standing whole-lower-extremity radiographs, the knee lateral view and skyline view of the participants will be taken.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The hip-knee-ankle angle
Time Frame: 1 day
|
The HKA angle was determined by measuring the angle between the mechanical axis of the femur and the mechanical axis of the tibia.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patellar alignment
Time Frame: 1 day
|
The lateral displacement of the patella was defined as the proportion of the distance from the lateral edge of the patella to a line drawn perpendicular to a line passing along the most anterior margin of the medial and lateral trochlear facets, by the length of the maximum width of the patella.
The tilting angle of the patella was defined as the angle formed by a line joining the maximum width of the patella and a line passing along the most anterior margin of the medial and lateral trochlear facets.
|
1 day
|
The width of of the patellofemoral joint space
Time Frame: 1 day
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The width of the joint space at the mid-point of the medial and lateral patellofemoral joint is measured on the skyline view.
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1 day
|
Trochlear morphology
Time Frame: 1 day
|
The sulcus angle was defined as the angle between the medial and lateral trochlear facets.
The vertex of the angle was the deepest portion of the trochlea.
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1 day
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Patellar height
Time Frame: 1 day
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The Insall-Salvati ratio is the ratio between the length of the patellar tendon and the superior-inferior length of the patella.
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1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Qingsheng Zhu, MD, Department of orthopaedics, Xijing hospital, Fourth Military Medical University, Xi'an, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 23, 2018
Primary Completion (Actual)
June 15, 2023
Study Completion (Actual)
June 15, 2023
Study Registration Dates
First Submitted
February 23, 2018
First Submitted That Met QC Criteria
February 24, 2018
First Posted (Actual)
March 1, 2018
Study Record Updates
Last Update Posted (Actual)
July 3, 2023
Last Update Submitted That Met QC Criteria
June 28, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 113YY-LUNLI-2018002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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