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Anterior Cruciate Ligament InjuriesNCT04633161

The Role of Muscle in Knee Stability

An observational study of Anterior Cruciate Ligament Injuries, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 35 years, men only
Conditions the study is for
Anterior Cruciate Ligament Injuries
How many people
30 participants
Where
1 siteHong Kong
Study dates
1 Aug 2019to 31 Jan 2020
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 18 to 35 years
  • Men only
  • Adult

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

Who may be able to join

  • (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

Who cannot join

  • (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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • The chinese University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: 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.

Read the 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.

Keywords
muscle strength, muscle elasticity, muscle coordination, knee stability
Medical subject headings
Anterior Cruciate Ligament Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. knee biomechanics during single leg hop landing

    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

    Measured: post-operatively 6-18 months

  2. muscle strength

    muscle peak torque of knee extension and knee flexion at 60°/s and 180°/s tested with isokinetic mode by Biodex

    Measured: post-operatively 6-18 months

  3. muscle elasticity

    muscle shear elastic modulus of vastus medialis, rectus femoris, vastus lateralis, semimembranosus,semitendinosus and biceps femoris was measured by ultrasound shear wave elastography

    Measured: post-operatively 6-18 months

  4. muscle coordination

    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

    Measured: post-operatively 6-18 months

Secondary outcomes (3)

  1. knee laxity

    anterior displacement of the tibia was measured using the KT-1000 arthrometerat 134 N with knee flexed at around 20°

    Measured: post-operatively 6-18 months

  2. subjective knee function

    International Knee Documentation Committee (IKDC) scoring system, which is consisted of 10 questions about symptoms and activity ranging from 0 to 100

    Measured: post-operatively 6-18 months

  3. Psychological readiness for return-to-play

    Anterior Cruciate Ligament-Return to Sport after Injury(ACL-RSI)-on a scale from 0 to 100

    Measured: post-operatively 6-18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2020
  2. Study start1 Aug 2019
  3. Primary completion31 Aug 2019
  4. Study completion31 Jan 2020

Resources

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
Cohort
Time perspective
Cross-sectional
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04633161
Sponsor's protocol ID
2019.100
Status last verified
Nov 2020
First submitted
11 Nov 2020
Last updated
18 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Anterior Cruciate Ligament Injuries, run by Chinese University of Hong Kong at 1 site in Hong Kong.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Nov 2020. 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 Hong Kong. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

knee biomechanics during single leg hop landing (time frame: post-operatively 6-18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04633161.

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 18 Nov 2020.

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