Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06464705

To Investigate the Effect of PEMF for Pateitns After Anterior Cruciate Ligament Reconstruction With Hamstring Autograft

Led by Chinese University of Hong Kong · Updated on 2024-06-20

60

Participants Needed

1

Research Sites

145 weeks

Total Duration

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AI-Summary

What this Trial Is About

Anterior cruciate ligament (ACL) tear is common. It accounts for over 50% of all knee injuries. Anterior cruciate ligament reconstruction (ACLR) with hamstring tendon (HT) autograft is the common graft choice for ACLR. However, the outcomes of donor site healing and recovery of muscle strength of HT are not satisfactory, resulting in hamstring muscle weakness and hamstring strength deficit during deep knee flexion, which may lead to hamstring strain after ACLR. Moreover, activation of the hamstring muscle is vital for maintaining dynamic knee joint stability and preventing excessive ACL shear forces. The presence of hamstring muscle deficits after surgery therefore affects the function of the reconstruction ACL. A previous study has reported that the hamstring muscle showed nearly 20% strength deficit at 4 months after ACLR with hamstring autograft Pulsed electromagnetic field (PEMF) treatment is a non-invasive therapy that has been shown to enhance muscle cell activity and accelerate tissue repair. In clinic, PEMF treatment has been reported to be safe. This study aims to conduct a double-blinded, placebo-controlled randomised clinical trial to investigate the effects of PEMF therapy for improving the tissue regeneration and strength of the HT donor site in ACLR patients with HT autograft.

CONDITIONS

Official Title

To Investigate the Effect of PEMF for Pateitns After Anterior Cruciate Ligament Reconstruction With Hamstring Autograft

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female aged 18 years or older at time of surgery
  • First anterior cruciate ligament reconstruction with hamstring tendon autograft
  • Both knees have no history of injury or prior surgery
  • Hamstring strength less than 85% of the opposite leg at 4 months after surgery
  • Voluntarily agreed to participate and signed informed consent form
Not Eligible

You will not qualify if you...

  • Any bone fracture, major meniscus injury, or full-thickness cartilage injury requiring changed rehabilitation after surgery
  • Signs of arthritis on preoperative X-rays
  • Other injuries such as fractures or ligament damage including neurovascular injury
  • Having a pacemaker, implantable defibrillator, neurosurgical clips, neurostimulator, cochlear implant, stent, or insulin pump
  • Pregnant or breastfeeding
  • Unable to give informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Prince of Wales Hospital

Shatin, Hong Kong

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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