Patellofemoral Pain SyndromeNCT03450824
Relationship Between Constitutional Varus Knee and Patellofemoral Pain
An observational study of Patellofemoral Pain Syndrome, run by 113th Hospital of Chinese People's Liberation Army at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Pain Syndrome
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2018to 15 Jun 2023
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Military personnel. Running at least 10 km per week for at least 3 months.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Orthopaedics clinic, No.113 Hospital of Chinese People's Liberation Army
Ningbo, Zhejiang, 315040
About this study
Official title: 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.
Read the 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.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- No intervention
- Keywords
- Patellofemoral Pain Syndrome, Anterior Knee Pain, Knee Varus
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
The standardized standing whole-lower-extremity radiographs, the knee lateral view and skyline view of the participants will be taken.
| Study group | Role | What they receive |
|---|---|---|
| The study group | The participants with patellofemoral pain. Receives: Other: No intervention | |
| The control group | The participants without patellofemoral pain. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The hip-knee-ankle angle
The HKA angle was determined by measuring the angle between the mechanical axis of the femur and the mechanical axis of the tibia.
Measured: 1 day
Secondary outcomes (4)
Patellar alignment
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.
Measured: 1 day
The width of of the patellofemoral joint space
The width of the joint space at the mid-point of the medial and lateral patellofemoral joint is measured on the skyline view.
Measured: 1 day
Trochlear morphology
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.
Measured: 1 day
Patellar height
The Insall-Salvati ratio is the ratio between the length of the patellar tendon and the superior-inferior length of the patella.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start23 Mar 2018
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Why it stopped: Because not enough volunteers were recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- 113th Hospital of Chinese People's Liberation Army
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Responsible party
- Sponsor
- Investigators
- Qingsheng Zhu, MD, Study director, Department of orthopaedics, Xijing hospital, Fourth Military Medical University, Xi'an, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450824
- Sponsor's protocol ID
- 113YY-LUNLI-2018002
- Status last verified
- Jun 2023
- First submitted
- 23 Feb 2018
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Relationship Between Constitutional Varus Knee and Patellofemoral Pain
- ClinicalTrials.gov ID
- NCT03450824
- Acronym / sponsor ID
- 113YY-LUNLI-2018002
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Patellofemoral Pain Syndrome, Anterior Knee Pain, Knee Varus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Because not enough volunteers were recruited.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- 113th Hospital of Chinese People's Liberation ArmyUniversity, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 1 Mar 2018 (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 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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The study group | – | Other: No interventionThe participants with patellofemoral pain. |
| The control group | – | Other: No interventionThe participants without patellofemoral pain. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Military personnel. Running at least 10 km per week for at least 3 months.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 interventionThe standardized standing whole-lower-extremity radiographs, the knee lateral view and skyline view of the participants will be taken. | Other | The control group, The study group |
Primary outcome
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.
4 secondary outcomes
Patellar alignment
Time frame: 1 day
The width of of the patellofemoral joint space
Time frame: 1 day
Trochlear morphology
Time frame: 1 day
Patellar height
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Because not enough volunteers were recruited.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 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.
Qingsheng Zhu, MD study director
Department of orthopaedics, Xijing hospital, Fourth Military Medical University, Xi'an, China
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 Patellofemoral Pain Syndrome, run by 113th Hospital of Chinese People's Liberation Army 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 3 Jul 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 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 was stopped early (reason given: Because not enough volunteers were recruited.). Results are not available in the source record.
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?
The hip-knee-ankle angle (time frame: 1 day). 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 3 Jul 2023.