Clinical trial NCT05395273: Cryocompression After Total Knee Arthroplasty
Official title: A Randomized Controlled Trial to Evaluate the Effectiveness of Cryocompression After Total Knee Arthroplasty (TKA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cryotherapy Effect
Lead sponsor: University of Applied Sciences and Arts of Southern Switzerland
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline (preoperatively) Knee and Osteoarthritis Outcome Score (KOOS) at postoperatively (4th day) and 6 weeks after surgery
timeFrame: preoperatively, postoperatively (4th day) and 6 weeks after surgery
measure: Change from Baseline (preoperatively) Range of motion at postoperatively (4th day) and 6 weeks after surgery
timeFrame: preoperatively, postoperatively (4th day) and 6 weeks after surgery
measure: Change from Baseline (preoperatively) Girth at postoperatively (4th day) and 6 weeks after surgery
timeFrame: preoperatively, postoperatively (4th day) and 6 weeks after surgery
measure: Change from Baseline (preoperatively) Timed up and Go at postoperatively (4th day) and 6 weeks after surgery
timeFrame: preoperatively, postoperatively (4th day) and 6 weeks after surgery
measure: Change from Baseline (preoperatively) Skin temperature at postoperatively (4th day) and 6 weeks after surgery
timeFrame: preoperatively, postoperatively (4th day) and 6 weeks after surgery
measure: Change from Baseline (preoperatively) Visual analogue scale at postoperatively (4th day) and 6 weeks after surgery
timeFrame: preoperatively, postoperatively (4th day) and 6 weeks after surgery
measure: Change from Baseline (preoperatively) 10 Metre Walk Test at postoperatively (4th day) and 6 weeks after surgery
timeFrame: preoperatively, postoperatively (4th day) and 6 weeks after surgery
measure: Change from Baseline (first day postperatively) Patient satisfaction at each day of hospitalisation
timeFrame: each day of hospitalisation
measure: Consumption of morphine
timeFrame: 6 weeks after surgery
measure: Length of stay
timeFrame: 6 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Landquart
country: Switzerland
facility: Fachhochschule Südschweiz
state: GR
Study officials:
affiliation: University of Applied Sciences and Arts of Southern Switzerland
name: Ron Clijsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: