Effect of Motorized Cryotherapy on Early Effusion, Swelling, and Pain After Anterior Cruciate Ligament Reconstruction
Sponsor
Hanyang University Seoul Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04222933
Collaborator
(none)
56
1
2
21.1
2.7
Study Details
Study Description
Brief Summary
To test the efficacy of motorized cryotherapy on early effusion, and pain after ACL reconstruction
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
To test the efficacy of motorized cryotherapy on early effusion, and pain after ACL reconstruction compared to classical ice bagging
Study Design
Study Type:
Interventional
Actual Enrollment
:
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Effect of Motorized Cryotherapy on Early Effusion, Swelling, and Pain After Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial
Actual Study Start Date
:
Apr 1, 2019
Actual Primary Completion Date
:
Mar 1, 2020
Actual Study Completion Date
:
Jan 1, 2021
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Pain after surgery [postoperative day 4]
VAS pain scale (0 to 10 points, higher the worse pain)
Secondary Outcome Measures
- Effusion after surgery [baseline, postoperative day 4, 7, 14, 6 weeks]
Effusion by thigh circumference (cm), MRI measurement (cc)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Orthopaedic Surgery, Hanyang University, College of Medicine | Seoul | Korea, Republic of | 133-792 |
Sponsors and Collaborators
- Hanyang University Seoul Hospital
Investigators
- Principal Investigator: JIN KYU LEE, PHD, Hanyang University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
JIN KYU LEE,
professor,
Hanyang University Seoul Hospital
ClinicalTrials.gov Identifier:
NCT04222933
Other Study ID Numbers:
- Hanyang university cryo
First Posted:
Jan 10, 2020
Last Update Posted:
Jun 22, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No