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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryocompression + standard therapy | Experimental | Participants received daily crycompression by the patient to their comfort level beside the standard therapy. |
|
| Standard therapy | No Intervention | The standard therapy include the common physical therapy interventions, which are normally used in the hospital. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Game Ready cryocompression | Device | Cryotherapy on the coldest tolerable level and intermittend compression on the knee |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ron Clijsen, PhD | University of Applied Sciences and Arts of Southern Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fachhochschule Südschweiz | Landquart | Kanton Graubünden | 7302 | Switzerland |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 21, 2022 | Aug 21, 2025 | Prot_SAP_000.pdf |
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| 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 |