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Recruiting NCT06464705

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

No phase Interventional Anterior Cruciate Ligament Reconstruction Hamstring Muscle

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PEMF treatment, Placebo treatment.
Who it may be relevant to
Registry conditions: Anterior Cruciate Ligament Reconstruction, Hamstring Muscle. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

  • Device PEMF treatment
    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.
  • Device Placebo treatment
    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 outcome measures

  • Isokinetic Test [Time frame: Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 5 months]
  • Isokinetic Test [Time frame: Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 6 months]
  • Isokinetic Test [Time frame: Change from baseline (post-ACLR 4 months) hamstring muscle strength at post-ACLR 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Prince of Wales Hospital — Shatin

Identifiers

NCT: NCT06464705 · 2024.130

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗