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NCT04222933 Clinical Trial

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

Cryotherapy Effect Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04222933
Other study ID # Hanyang university cryo
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date January 1, 2021

Study information
Verified date June 2021
Source Hanyang University Seoul Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date January 1, 2021
Est. primary completion date March 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Motorized cryotherapy
application of motorized cryotherapy after ACL reconstruction
• Classical cryotherapy
application of an ice bag

Locations
Country Name City State
Korea, Republic of Department of Orthopaedic Surgery, Hanyang University, College of Medicine Seoul

Sponsors (1)
Lead Sponsor Collaborator
Hanyang University Seoul Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain after surgery VAS pain scale (0 to 10 points, higher the worse pain) postoperative day 4
Secondary Effusion after surgery Effusion by thigh circumference (cm), MRI measurement (cc) baseline, postoperative day 4, 7, 14, 6 weeks
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