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

Not Applicable

Completed

• Conditions: Cryotherapy Effect
• Interventions: Device: Motorized cryotherapy; Device: Classical cryotherapy

• Registration Number: NCT04222933
• Lead Sponsor: Hanyang University Seoul Hospital

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2020-01-05
• Study First Submitted QC: 2020-01-07
• Study First Posted: 2020-01-10
• Primary Completion: 2020-03-01
• Study Completion: 2021-01-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-16
• Last Update Posted: 2021-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motorized cryotherapy	Motorized cryotherapy	Application of motorized cryotherapy after ACL reconstruction for 6 postoperative days
Classical cryotherapy	Classical cryotherapy	Application of ice bags for 6 postoperative days

Primary Outcome Measures

Name	Time	Method
Pain after surgery	postoperative day 4	VAS pain scale (0 to 10 points, higher the worse pain)

Secondary Outcome Measures

Name	Time	Method
Effusion after surgery	baseline, postoperative day 4, 7, 14, 6 weeks	Effusion by thigh circumference (cm), MRI measurement (cc)

Trial Locations

Locations (1)

Department of Orthopaedic Surgery, Hanyang University, College of Medicine; 🇰🇷 Seoul, Korea, Republic of