Viewing Study NCT04136431



Ignite Creation Date: 2024-05-06 @ 1:50 PM
Last Modification Date: 2024-10-26 @ 1:20 PM
Study NCT ID: NCT04136431
Status: COMPLETED
Last Update Posted: 2019-10-23
First Post: 2019-10-20

Brief Title: Effects of Programmed Cryotherapy and Continuous Passive Motion After Computer-Assisted Total Knee Arthroplasty
Sponsor: Chang Gung Memorial Hospital
Organization: Chang Gung Memorial Hospital

Study Overview

Official Title: The Effects of Programmed Cryotherapy and Continuous Passive Motion in Patients After Computer-Assisted Total Knee Arthroplasty A Prospective Randomized Controlled Trial
Status: COMPLETED
Status Verified Date: 2012-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The hypothesis of this study was the patients who received programed cryotherapy and CPM had experienced less postoperative pain joint swelling and increased ROM following CAS-TKA
Detailed Description: The International Association for the Study of Pain IASP has proposed the definition of pain as an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage Therefore adequate pain management and control of localized swelling and stiffness after TKA has become a priority because it is essential for improving patient satisfaction prevention of complications and enhancing quality of life by faster recovery Systemic and local analgesics are the most common strategies for postoperative pain management in TKR However patients might experience nausea vomiting constipation or respiratory failure due to opioid-related side effects subsequently refusing to mobilize and delaying the rehabilitation program

In addition to pain control cryotherapy and continuous passive motion CPM are commonly used for TKA patients as non-pharmacological methods to reduce the postoperative pain and swelling and to increase the amount of knee flexion The application of cryotherapy after TKA has been described extensively in the literature and is part of standard care globally However its benefits and value remain controversial due to the disparity in practice such as differences in clinical protocols and the type of cryotherapy application Continuous passive motion is a motorized device which passively moves the knee joint within a certain range of motion ROM to decrease analgesics requirements reduce the incidence of deep vein thrombosis and increase ROM But the effects of CPM remain contentious in the literature Although controversial cryotherapy and CPM have been used extensively as part of the standard postoperative management protocol for TKA patients without knowing its cost-effectiveness However the value of combined therapy of cryotherapy and CPM remains uncertainty and unclear following CAS-TKA

The hypothesis of this study was the patients who received programed cryotherapy and CPM had experienced less postoperative pain joint swelling and increased ROM following CAS-TKA

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None