The Role of Muscle in Knee Stability

November 11, 2020 updated by: Xin He, Chinese University of Hong Kong

The Role of Quadriceps and Hamstring Muscles in Knee Stability During Single Leg Hop Landing in Patients With Anterior Cruciate Ligament Reconstruction

This project aims to compare the difference in muscle strength, muscle elasticity and muscle coordination of quadriceps and hamstring muscle and their association with knee biomechanics during single leg hop landing in patients with anterior cruciate ligament reconstruction.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

In Hong Kong, over 3000 cases of Anterior Cruciate Ligament Reconstruction (ACLR) are operated annually to restore knee stability. Despite recovery of knee passive laxity and muscle strength, dynamic knee stability is often not restored. In additional to muscle strength, muscle elasticity and muscle coordination may also play an important role in knee stability. However, there is no evidence regarding the changes in muscle elasticity after ACLR and its contribution to dynamic knee stability. This study is a cross-sectional study designed to compare the the difference in muscle strength, muscle elasticity and muscle coordination of quadriceps and hamstring muscle in 30 ACLR patients and investigate its relationship with knee biomechanics during single leg hop landing. Patient selection was base on medical records and subjective knee functional scores. Patient enrollment and informed consent was conducted first. Muscle strength was measured by isokinetic muscle testing(Biodex) at two speeds. Muscle elasticity was assessed by ultrasound shear wave elastography. Muscle coordination evaluated by electromyography(EMG) and knee biomechanics including kinematics and kinetics was measured by 3D motion analysis system(VICON) and all the assessments were done in CUHK-ORT Sports Injury Research Laboratory in the Prince of Wales Hospital, Hong Kong. All data was collected and analyzed by qualified personnel.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

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

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Chinese University of Hong Kong

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Young and active ACL patients within their post-ACLR 6-18 months

Description

Inclusion Criteria:

  • (1) Male aged 18-35 (2) With pre-injury activity level of more than 6 in Tegner score (3) Within their post-operative 6-18 months (4) Without injury history for the contralateral limb

Exclusion Criteria:

  • (1) With concomitant fracture, meniscus injury or chondral lesion (2) With preoperative radiographic signs of arthritis (3) With revision ACL surgery (4) With injury history of the spine or hamstring strain during the past 6 months.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
knee biomechanics during single leg hop landing
Time Frame: post-operatively 6-18 months
knee kinematics(peak knee flexion, knee valgus, knee internal rotation, knee flexion excursion, valgus excursion and internal excursion) and kinetics(vertical ground reaction force, knee extension moment, knee valgus moment) were collected by 3D motion analysis system(VICON) during the landing phase of single leg hop test
post-operatively 6-18 months
muscle strength
Time Frame: post-operatively 6-18 months
muscle peak torque of knee extension and knee flexion at 60°/s and 180°/s tested with isokinetic mode by Biodex
post-operatively 6-18 months
muscle elasticity
Time Frame: post-operatively 6-18 months
muscle shear elastic modulus of vastus medialis, rectus femoris, vastus lateralis, semimembranosus,semitendinosus and biceps femoris was measured by ultrasound shear wave elastography
post-operatively 6-18 months
muscle coordination
Time Frame: post-operatively 6-18 months
muscle activity level and onset time of vastus medialis, vastus lateralis, semimembranosus,and biceps femoris was assessed by electromyography(EMG) during the landing phase of single leg hop test
post-operatively 6-18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
knee laxity
Time Frame: post-operatively 6-18 months
anterior displacement of the tibia was measured using the KT-1000 arthrometerat 134 N with knee flexed at around 20°
post-operatively 6-18 months
subjective knee function
Time Frame: post-operatively 6-18 months
International Knee Documentation Committee (IKDC) scoring system, which is consisted of 10 questions about symptoms and activity ranging from 0 to 100
post-operatively 6-18 months
Psychological readiness for return-to-play
Time Frame: post-operatively 6-18 months
Anterior Cruciate Ligament-Return to Sport after Injury(ACL-RSI)-on a scale from 0 to 100
post-operatively 6-18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019.100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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