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Completed

NCT Number: NCT04222933

Effect of Motorized Cryotherapy on Early Effusion, Swelling, and Pain After Anterior Cruciate Ligament Reconstruction

To test the efficacy of motorized cryotherapy on early effusion, and pain after ACL reconstruction

Completed

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Key information

Conditions

Cryotherapy Effect

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopaedic Surgery, Hanyang University, College of Medicine

Seoul, 133-792, South Korea

About this study

To test the efficacy of motorized cryotherapy on early effusion, and pain after ACL reconstruction compared to classical ice bagging

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Acute ACL ruptured patient

Exclusion criteria

  • Combined meniscal injury requiring surgery
  • Combined ligament injury requiring surgery
  • Combined chondral injury requiring surgery
  • Previous surgery history on corresponding knee
  • Allergic to cold

Treatment and study plan

Motorized cryotherapy

Device

application of motorized cryotherapy after ACL reconstruction

Classical cryotherapy

Device

application of an ice bag

Primary outcomes

  1. Pain after surgery

    Time frame: postoperative day 4

    VAS pain scale (0 to 10 points, higher the worse pain)

Secondary outcomes

  1. Effusion after surgery

    Time frame: baseline, postoperative day 4, 7, 14, 6 weeks

    Effusion by thigh circumference (cm), MRI measurement (cc)

Sponsors and collaborators

Lead sponsor

Hanyang University Seoul Hospital

Other

Registry information

Official study title

Effect of Motorized Cryotherapy on Early Effusion, Swelling, and Pain After Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jan 10, 2020
Registry last updated
Jun 22, 2021

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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