Effect of Motorized Cryotherapy on Early Effusion, Swelli... | NCT04222933

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

NCT04222933

Sponsor

Hanyang University Seoul Hospital

Status

Completed

Last Update Posted

Jun 22, 2021Actual

Enrollment

56Actual

Phase

Not Applicable

Conditions

Cryotherapy Effect

Interventions

Motorized cryotherapy
Classical cryotherapy

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Mar 1, 2020Actual

Completion Date

Jan 1, 2021Actual

First Submitted Date

Jan 5, 2020

First Submission Date that Met QC Criteria

Jan 7, 2020

First Posted Date

Jan 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2021

Last Update Posted Date

Jun 22, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Motorized cryotherapy	Experimental	Application of motorized cryotherapy after ACL reconstruction for 6 postoperative days	Device: Motorized cryotherapy
Classical cryotherapy	Active Comparator	Application of ice bags for 6 postoperative days	Device: Classical cryotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Motorized cryotherapy	Device	application of motorized cryotherapy after ACL reconstruction	Motorized cryotherapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
JIN KYU LEE, PHD	Hanyang University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Orthopaedic Surgery, Hanyang University, College of Medicine		Seoul		133-792	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided