Cryocompression After Total Knee Arthroplasty

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

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

Study Overview

• Status: Completed
• Conditions: Cryotherapy Effect
• Intervention / Treatment: Device: Game Ready cryocompression

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ron Clijsen, PhD; Phone Number: +41 (81) 300 01 75; Email: ron.clijsen@supsi.ch

Study Locations

• Switzerland
  • GR
    • Landquart, GR, Switzerland, 7302
      • Fachhochschule Südschweiz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cryocompression + standard therapy; Participants received daily crycompression by the patient to their comfort level beside the standard therapy.	Device: Game Ready cryocompression; Cryotherapy on the coldest tolerable level and intermittend compression on the knee
No Intervention: Standard therapy; The standard therapy include the common physical therapy interventions, which are normally used in the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
Consumption of morphine	Consumption of morphine in number of pills	6 weeks after surgery
Length of stay	Length of stay in the hospital in days	6 weeks after surgery

Collaborators and Investigators

• Sponsor: University of Applied Sciences and Arts of Southern Switzerland
• Investigators: Principal Investigator: Ron Clijsen, PhD, University of Applied Sciences and Arts of Southern Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Actual): August 28, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2022-D0056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No