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NCT Number: NCT06464705

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

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.

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Key information

Conditions

Anterior Cruciate Ligament Reconstruction Hamstring Muscle

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female with age ≥ 18 years at the time of surgery
  • First ACLR with HT autograft
  • Both knees without a history of injury/prior surgery
  • LSI for hamstring strength <85% of contralateral leg at 4-month isokinetic assessment (70)
  • Voluntarily agreed to participate and signed the informed consent form

Exclusion criteria

  • Any concomitant bone fracture, major meniscus injury or full-thickness chondral injuries requiring altered rehabilitation program post-op
  • Preoperative radiographic signs of arthritis
  • Other associated injuries (fractures and other ligament involvement such as neurovascular bundles injury)
  • Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent, an insulin pump
  • Pregnant or breastfeeding
  • Inability to give informed consent

Treatment and study plan

PEMF treatment

Device

Pulsed electromagnetic field (PEMF) therapy is an emerging modality for the treatment of musculoskeletal disorders. Time-varying magnetic pulses are generated by passing an electrical current through a coil. PEMF has been shown to be effective in vitro and in vivo studies for tissue repair and accelerating muscle regeneration. In each treatment, you need to put the reconstructed limb into the machine for 10 minutes.

Placebo treatment

Device

In this study the placebo group uses the same PEMF machine, but it does not generate any electrical current that have treatment effect. As the active PEMF device does not produce heat or cause any sensation to the tissue, participants are blinded to the treatment. In each treatment, you need to put the reconstructed limb into the machine for 10 minutes.

Primary outcomes

  1. Isokinetic Test

    Time frame: Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 5 months

    The Cybex dynamometer will be used to test the hamstring muscle strength.

  2. Isokinetic Test

    Time frame: Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 6 months

    The Cybex dynamometer will be used to test the hamstring muscle strength.

  3. Isokinetic Test

    Time frame: Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 12 months

    The Cybex dynamometer will be used to test the hamstring muscle strength.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Effect of Pulsed Electromagnetic Fields on Promoting Hamstring Muscle Strength After Anterior Cruciate Ligament Reconstruction With Hamstring Autograft: A Double-Blind, Placebo-Controlled, Randomised Clinical Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 18, 2024
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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