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

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

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

Study Overview

• Status: Completed
• Conditions: Cryotherapy Effect
• Intervention / Treatment: Device: Motorized cryotherapy; Device: Classical cryotherapy

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 133-792
    • Department of Orthopaedic Surgery, Hanyang University, College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motorized cryotherapy; Application of motorized cryotherapy after ACL reconstruction for 6 postoperative days	Device: Motorized cryotherapy; application of motorized cryotherapy after ACL reconstruction
Active Comparator: Classical cryotherapy; Application of ice bags for 6 postoperative days	Device: Classical cryotherapy; application of an ice bag

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain after surgery	VAS pain scale (0 to 10 points, higher the worse pain)	postoperative day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effusion after surgery	Effusion by thigh circumference (cm), MRI measurement (cc)	baseline, postoperative day 4, 7, 14, 6 weeks

Collaborators and Investigators

• Sponsor: Hanyang University Seoul Hospital
• Investigators: Principal Investigator: JIN KYU LEE, PHD, Hanyang University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: January 5, 2020
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Hanyang university cryo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No