NCT04222933

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

June 22, 2021

Status Verified

June 1, 2021

Enrollment Period

11 months

First QC Date

January 5, 2020

Last Update Submit

June 16, 2021

Conditions

Cryotherapy Effect

Outcome Measures

Primary Outcomes (1)

  • Pain after surgery

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

    postoperative day 4

Secondary Outcomes (1)

  • Effusion after surgery

    baseline, postoperative day 4, 7, 14, 6 weeks

Study Arms (2)

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

Motorized cryotherapyDEVICE

application of motorized cryotherapy after ACL reconstruction

Motorized cryotherapy
Classical cryotherapyDEVICE

application of an ice bag

Classical cryotherapy

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Acute ACL ruptured patient

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedic Surgery, Hanyang University, College of Medicine

Seoul, 133-792, South Korea

Location

Study Officials

  • JIN KYU LEE, PHD

    Hanyang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 5, 2020

First Posted

January 10, 2020

Study Start

April 1, 2019

Primary Completion

March 1, 2020

Study Completion

January 1, 2021

Last Updated

June 22, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)