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

Last updated: June 17, 2024
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Placebo treatment

PEMF treatment

Pulsed electromagnetic field (PEMF)

Clinical Study ID

NCT06464705
2024.130
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male and female with age ≥ 18 years at the time of surgery

  2. First ACLR with HT autograft

  3. Both knees without a history of injury/prior surgery

  4. LSI for hamstring strength <85% of contralateral leg at 4-month isokineticassessment (70)

  5. Voluntarily agreed to participate and signed the informed consent form

Exclusion

Exclusion Criteria:

  1. Any concomitant bone fracture, major meniscus injury or full-thickness chondralinjuries requiring altered rehabilitation program post-op

  2. Preoperative radiographic signs of arthritis

  3. Other associated injuries (fractures and other ligament involvement such asneurovascular bundles injury)

  4. Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, aneurostimulator, cochlear implant, a stent, an insulin pump

  5. Pregnant or breastfeeding

  6. Inability to give informed consent

Study Design

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: Placebo treatment
Phase:
Study Start date:
June 13, 2024
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Prince of Wales Hospital

    Sha Tin,
    Hong Kong

    Active - Recruiting

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