NCT03450824

Brief 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. 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

March 23, 2018

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

5.2 years

First QC Date

February 23, 2018

Last Update Submit

June 28, 2023

Conditions

Keywords

Patellofemoral Pain SyndromeAnterior Knee PainKnee Varus

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (4)

  • Patellar alignment

    1 day

  • The width of of the patellofemoral joint space

    1 day

  • Trochlear morphology

    1 day

  • Patellar height

    1 day

Study Arms (2)

The study group

The participants with patellofemoral pain.

Other: No intervention

The control group

The participants without patellofemoral pain.

Other: No intervention

Interventions

The standardized standing whole-lower-extremity radiographs, the knee lateral view and skyline view of the participants will be taken.

The control groupThe study group

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Military personnel. Running at least 10 km per week for at least 3 months.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedics clinic, No.113 Hospital of Chinese People's Liberation Army

Ningbo, Zhejiang, 315040, China

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Qingsheng Zhu, MD

    Department of orthopaedics, Xijing hospital, Fourth Military Medical University, Xi'an, China

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 1, 2018

Study Start

March 23, 2018

Primary Completion

June 15, 2023

Study Completion

June 15, 2023

Last Updated

July 3, 2023

Record last verified: 2023-06

Locations