Cryocompression After Total Knee Arthroplasty

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

Detailed Description
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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.

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

Conditions
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Cryotherapy Effect

Intervention / Treatment
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* Device: Game Ready cryocompression


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |