NCT05294783

Brief Summary

Patients with anterior cruciate ligament (ACL) injury often suffer knee instability, which can be visualized as a wobbling knee during weight bearing exercises, such as the single leg squat. We propose to use the single-leg-squat-and-hold (SLSH) task with kinematic analysis to objectively evaluate dynamic knee stability in ACL injured patients. The aim of this study is (1) to compare knee kinematic variations capturing knee wobbling during SLSH between ACL subjects and healthy controls; and (2) to detect the changes in knee kinematic variations during SLSH following ACL reconstruction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

Typical duration 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

Study Start

First participant enrolled

July 1, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

3.5 years

First QC Date

March 10, 2022

Last Update Submit

March 21, 2022

Conditions

Keywords

single leg squatknee instabilityACL reconstructionKinematics

Outcome Measures

Primary Outcomes (6)

  • Changes from baseline knee range of flexion-extension at 3 months after ACLR

    knee range of flexion-extension will be measured during 10s holding phase of the single leg squat and hold test

    three months post-operatively

  • Changes from baseline knee range of varus-valgus at 3 months after ACLR

    knee range of virus-valgus will be measured during 10s holding phase of the single leg squat and hold test

    three months post-operatively

  • Changes from baseline knee range of internal-external rotation at 3 months after ACLR

    knee range of internal-external rotation will be measured during 10s holding phase of the single leg squat and hold test

    one month pre-operatively and three months post-operatively

  • Changes from baseline frequency of knee flexion-extension at 3 months after ACLR

    the frequency of the relative flexion-extension movements will be quantified by the number of peak appearances during 10s holding phase of the single leg squat and hold test

    three months post-operatively

  • Changes from baseline frequency of knee varus-valgus at 3 months after ACLR

    the frequency of the relative varus-valgus movements will be quantified by the number of peak appearances during 10s holding phase of the single leg squat and hold test

    three months post-operatively

  • Changes from baseline frequency of knee internal-external rotation

    he frequency of the relative internal-external movements will be quantified by the number of peak appearances during 10s holding phase of the single leg squat and hold test

    three months post-operatively

Secondary Outcomes (1)

  • Changes from baseline International Knee Documentation Committee(IKDC) score at 3 months after ACLR

    three months post-operatively

Study Arms (1)

ACL injured patients

All the ACL injured patients recruited underwent ACL reconstruction with the same group of surgeons lead by the same chief surgeon.

Procedure: ACL reconstruction

Interventions

ACL reconstruction is a standard surgery for ACL injured patients

ACL injured patients

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Elite or recreational athletes with ACL injury who suffer knee instability and require surgical reconstruction

You may qualify if:

  • Aged 18-35;
  • Participate in level I or level II sports with a Tegner score of more than 6 before injury(level I: sports involving jumping, cutting and pivoting, e.g.football, basketball etc; Level II: sports involving lateral movements, less pivoting than Level I eg. racket sports)
  • Scheduled for ACLR because of unilateral ACL injury;
  • Failure to meet any single criteria for a potential coper;
  • Contralateral knee without history of injury.

You may not qualify if:

  • Concomitant fracture, meniscus injury or full-thickness chondral injuries;
  • preoperative radiographic signs of arthritis;
  • Revision ACL surgery;
  • With ankle pain, hip pain, low back pain or spine pathology;
  • Woman with pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Xin HE, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 24, 2022

Study Start

July 1, 2018

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

March 24, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations