Intervention Study on the Recovery Process of Knee Muscle Strength in Patients Following Anterior Cruciate Ligament Reconstruction

JRCT ID: jRCT1032230462

Registered date:19/11/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Anterior Cruciate Ligament injury
• Date of first enrollment: 19/11/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): The patient is placed in a resting back position on a platform, and an observer places an echo on the knee on the operative side for evaluation. The MRI results are collected from the electronic medical record at the time of examination at the affiliated hospital. Surface electromyography will evaluate quadriceps muscle activity during maximal isometric knee extension-flexion (%MVC) and isokinetic knee extension-flexion movements using a dedicated BIODEX device with the patient in a sitting position.

Outcome(s)

Primary Outcome

Evaluation of musculoskeletal muscles and non-contractile tissues around the knee joint (muscle thickness, muscle brightness) using ultrasound imaging system (echo)
Knee isokinetic knee extension and flexion muscle strength (using BIODEX system4)

Secondary Outcome

ACL Osteoarthritis Score and Ligamentization (maturity of reconstructive ligament) by magnetic resonance imaging (MRI)
Knee joint function evaluation (single leg hop test)
Quantitative evaluation of knee extensor and flexor muscles using surface electromyography (EM-701M2, Noraxon)
Subjective, patient-oriented evaluation of the knee joint; IKDC (International Knee Documentation Committee) score, KOOS (Knee Injury and Osteoarthritis Outcome Score), Tegner Activity Scale score, Lysholm Knee Questionnaire score

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who can give written consent
Patients with first-time or ACL re-tear injuries
Must be observable for the entire duration of the study

Exclude criteria

Patients who are not considered appropriate for the study by the investigator
Patients with complex injuries to ligaments other than the ACL
Patients with bleeding tendency or complications that may cause problems in training.
Patients who cannot undergo MRI imaging (e.g., after closed body metal implantation)
Patients who cannot be observed for the entire study period at the time of consent.

Related Information

• Primary Sponsor: Kikuchi Naoya