Cryocompression After Total Knee Arthroplasty

Cryotherapy Effect Clinical Trial

Official title:

A Randomized Controlled Trial to Evaluate the Effectiveness of Cryocompression After Total Knee Arthroplasty (TKA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05395273
• Other study ID #: 2022-D0056
• Status: Completed
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: September 15, 2023

Study information

• Verified date: April 2024
• Source: University of Applied Sciences and Arts of Southern Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall aim of this study is to evaluate the effectiveness of a cryocompression device after total knee arthroplasty (TKA) compared to standard therapy.

Description:

The aim of this study is to investigate the effect of cryocompression after total knee arthroplasty (TKA) compared to a control group without cryocompression. The effect on the following parameters will be evaluated: knee and osteoarthritis outcome score (KOOS), patient satisfaction, knee girth, skin temperature, knee range of motion, morphine consumption, pain perception, the length of stay, the 10-metre walk test and the timed-up-and-go.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 15, 2023
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Signed Informed Consent

• Diagnosed Arthritis of the Knee

• Planned implantation of a primary total knee arthroplasty by the Regionalspital Surselva AG

Exclusion Criteria:

• Decompensated hypertension in the affected area

• Acute inflammatory phlebitis in the affected area

• Patients with acute paroxysmal cold hemoglobinuria, or cryoglobulinemia

• Significant vascular disruption in the affected area

• History of pulmonary embolism or risk factors for deep vein thrombosis or pulmonary embolism in the affected area

• No increased venous or lymphatic return in the affected leg is desired due to e.g. carcinoma

• Raynaud's disease

• Hypersensitivity to cold

• Fear of cold/compression

Related Conditions & MeSH terms

• Cryotherapy Effect

Intervention

Device:
• Game Ready cryocompression
Cryotherapy on the coldest tolerable level and intermittend compression on the knee

Locations

Country	Name	City	State
Switzerland	Fachhochschule Südschweiz	Landquart	GR

Sponsors (1)

Lead Sponsor	Collaborator
University of Applied Sciences and Arts of Southern Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline (preoperatively) Knee and Osteoarthritis Outcome Score (KOOS) at postoperatively (4th day) and 6 weeks after surgery	A knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems	preoperatively, postoperatively (4th day) and 6 weeks after surgery
Primary	Change from Baseline (preoperatively) Range of motion at postoperatively (4th day) and 6 weeks after surgery	Range of motion of the knee	preoperatively, postoperatively (4th day) and 6 weeks after surgery
Primary	Change from Baseline (preoperatively) Girth at postoperatively (4th day) and 6 weeks after surgery	Knee girth	preoperatively, postoperatively (4th day) and 6 weeks after surgery
Primary	Change from Baseline (preoperatively) Timed up and Go at postoperatively (4th day) and 6 weeks after surgery	A general physical performance test used to assess mobility, balance and locomotor performance	preoperatively, postoperatively (4th day) and 6 weeks after surgery
Primary	Change from Baseline (preoperatively) Skin temperature at postoperatively (4th day) and 6 weeks after surgery	Skin temperature of the knee	preoperatively, postoperatively (4th day) and 6 weeks after surgery
Primary	Change from Baseline (preoperatively) Visual analogue scale at postoperatively (4th day) and 6 weeks after surgery	To measure the intensity of pain	preoperatively, postoperatively (4th day) and 6 weeks after surgery
Primary	Change from Baseline (preoperatively) 10 Metre Walk Test at postoperatively (4th day) and 6 weeks after surgery	To assess walking speed in meters per second over 10 metres	preoperatively, postoperatively (4th day) and 6 weeks after surgery
Primary	Change from Baseline (first day postperatively) Patient satisfaction at each day of hospitalisation	To measure the patient satisfaction of the cryocompression therapy from 0 to 10	each day of hospitalisation
Primary	Consumption of morphine	Consumption of morphine in number of pills	6 weeks after surgery
Primary	Length of stay	Length of stay in the hospital in days	6 weeks after surgery