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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05294783
Other study ID # 2018.134
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2018
Est. completion date December 30, 2021

Study information

Verified date March 2022
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Injuries to the anterior cruciate ligament (ACL) are common in pivoting sports such as soccer, handball, basketball and rugby. The ultimate goal of ACL reconstruction for most athletes is return-to-play. Despite successful surgery and a demanding rehabilitation process, some athletes still failed to return to play, and for those who returned to play, some would suffer a second ACL injury. With surgical reconstruction of the ACL, static knee stability can be restored, but dynamic knee stability may not . Patients with ACL injury often experience symptoms such as knee instability, feelings of "giving way" during activities. Biomechanically, dynamic knee stability is considered as the ability to control the relative tibiofemoral displacements during loading. Regular monitoring of the knee stability before and after ACL reconstruction is necessary for medical personnel to design the most suitable rehabilitation program. In contrast to jumping and hopping tasks, squatting tasks present a similar weight bearing profile during knee flexion, but without the potentially risky landing phase. As poor knee dynamic knee stability can be visualized as a wobbling knee (frequent knee movements). In order to quantitatively and objectively evaluate dynamic knee stability from observing the knee wobbling motion, we propose a single leg squat and hold task(SLSH) with kinematic analysis. Kinematic curve derived from the SLSH involves both the magnitudes and the frequency of the motion fluctuation. This study aims (1) to compare knee kinematic variations capturing knee wobbling during SLSH between ACL-deficient patients who are scheduled for ACLR and healthy controls; and(2)to detect the changes in knee kinematic variations during SLSH following ACLR. We hypothesize that the ACL-deficient patients demonstrate greater knee kinematic variation than the healthy subjects and the knee kinematic variation will reduce after ACLR.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: 1. Aged 18-35; 2. 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) 3. Scheduled for ACLR because of unilateral ACL injury; 4. Failure to meet any single criteria for a potential coper; 5. Contralateral knee without history of injury. Exclusion Criteria: 1. Concomitant fracture, meniscus injury or full-thickness chondral injuries; 2. preoperative radiographic signs of arthritis; 3. Revision ACL surgery; 4. With ankle pain, hip pain, low back pain or spine pathology; 5. Woman with pregnancy.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
ACL reconstruction
ACL reconstruction is a standard surgery for ACL injured patients

Locations

Country Name City State
Hong Kong The Chinese University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Changes from baseline International Knee Documentation Committee(IKDC) score at 3 months after ACLR The IKDC is consisted of 10 questions about symptoms and activity ranging from 0 to 100 where 100 implies perfect knee function three months post-operatively
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