Cryotherapy Effect
Conditions
Brief 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.
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.
Interventions
DEVICEGame Ready cryocompression
Cryotherapy on the coldest tolerable level and intermittend compression on the knee
Sponsors
University of Applied Sciences and Arts of Southern Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline (preoperatively) Knee and Osteoarthritis Outcome Score (KOOS) at postoperatively (4th day) and 6 weeks after surgery | preoperatively, postoperatively (4th day) and 6 weeks after surgery | A knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems |
| Change from Baseline (preoperatively) Range of motion at postoperatively (4th day) and 6 weeks after surgery | preoperatively, postoperatively (4th day) and 6 weeks after surgery | Range of motion of the knee |
| Change from Baseline (preoperatively) Girth at postoperatively (4th day) and 6 weeks after surgery | preoperatively, postoperatively (4th day) and 6 weeks after surgery | Knee girth |
| Change from Baseline (preoperatively) Timed up and Go at postoperatively (4th day) and 6 weeks after surgery | preoperatively, postoperatively (4th day) and 6 weeks after surgery | A general physical performance test used to assess mobility, balance and locomotor performance |
| Change from Baseline (preoperatively) Skin temperature at postoperatively (4th day) and 6 weeks after surgery | preoperatively, postoperatively (4th day) and 6 weeks after surgery | Skin temperature of the knee |
| Change from Baseline (preoperatively) Visual analogue scale at postoperatively (4th day) and 6 weeks after surgery | preoperatively, postoperatively (4th day) and 6 weeks after surgery | To measure the intensity of pain |
| Change from Baseline (preoperatively) 10 Metre Walk Test at postoperatively (4th day) and 6 weeks after surgery | preoperatively, postoperatively (4th day) and 6 weeks after surgery | To assess walking speed in meters per second over 10 metres |
| Change from Baseline (first day postperatively) Patient satisfaction at each day of hospitalisation | each day of hospitalisation | To measure the patient satisfaction of the cryocompression therapy from 0 to 10 |
| Consumption of morphine | 6 weeks after surgery | Consumption of morphine in number of pills |
| Length of stay | 6 weeks after surgery | Length of stay in the hospital in days |
Countries
Switzerland
Outcome results
None listed