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

NCT06464705 | Recruiting

• 1 other identifier: 2024.130
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anterior Cruciate Ligament Reconstruction; Hamstring Muscle

Outcome Measures

Primary Outcomes (3)

• Isokinetic Test

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

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

• Isokinetic Test

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

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

• Isokinetic Test

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

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

Study Arms (2)

PEMF treatment

EXPERIMENTAL

Patient will receive a PEMF treatment. The involved leg will be exposed to PEMF for 10 minutes per session, and the treatment regime will run two times a week for eight weeks, summing up 16 sessions of PEMF exposure in total.

Device: PEMF treatment

Placebo treatment

PLACEBO COMPARATOR

Patient will receive a placebo treatment. The involved leg will be exposed to placebo treatment for 10 minutes per session, and the treatment regime will run two times a week for eight weeks, summing up 16 sessions of placebo exposure in total.

Device: Placebo treatment

Interventions

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.

PEMF treatment

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.

Placebo treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: June 13, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)