NCT04982679

Brief Summary

Patellofemoral pain is a common disease, and it often couples with patellar malalignment. Previously, imbalance of the different quadriceps muscle heads was believed to be a causative factor of patellar malignment. However, findings from electromyography studies on quadriceps activities and patellar alignment in the last two decades were inconsistent. In order to better understand the relationship between quadriceps muscle imbalance and patellar malalignment, shear wave elastography (SWE), which can measure the passive and active muscle stiffness, may shed some new lights to this area. This study aims to examine whether the quadriceps muscle stiffness can predict the patellar position. The healthy young adult will be recruited in this study. Active and passive quadriceps muscle stiffness will be measured with the SWE in different conditions and the result will be correlated with the patellar position measured with magnetic resonance imaging (MRI). Also, electromyography (EMG) activity will be measured during the active stiffness measurement so as to establish the level of agreement between the EMG and SWE data. Linear regression will be used to calculate the relationship between different factors. The total number of subjects needed will be 55 by setting an effect size of 0.15 with two predictors, 80% power, and α at 0.05 in the linear regression. This project will be conducted at PolyU campus and an MRI clinic in Hong Kong. Hopefully, it could be started in July 2021 and will last for 1 year.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 20, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

November 26, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2022

Completed
Last Updated

March 16, 2022

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

July 20, 2021

Last Update Submit

March 15, 2022

Conditions

Keywords

muscle stiffnesspatellofemoral alignment

Outcome Measures

Primary Outcomes (2)

  • Patellofemoral Joint Alignment measured by MRI scanning

    Patellar displacement, patellar Alta/Baja and patellar tilt angle

    Within 1 hour

  • Muscle stiffness measured by ultragraph using shear wave elastography

    Raw data of vastus lateralis, rectus femoris and vastus medialis obliquus shear modulus

    Within 1 hour

Secondary Outcomes (2)

  • Muscle activity measured by electromyography

    Within 1 hour

  • Muscle strength

    Within 0.5 hour

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy subject without patellofemoral joint problem

You may qualify if:

  • Healthy and in the range between 18 and 45 years.

You may not qualify if:

  • Knee pain in the last 3 months;
  • Previous history of knee surgery;
  • People with contraindications to having MRI scanning.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Polytechnic University

Hung Hom, 000000, Hong Kong

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2021

First Posted

July 29, 2021

Study Start

November 26, 2021

Primary Completion

February 9, 2022

Study Completion

February 9, 2022

Last Updated

March 16, 2022

Record last verified: 2021-07

Locations