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Completed

NCT Number: NCT05395273

Cryocompression After Total Knee Arthroplasty

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

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Key information

Conditions

Cryotherapy Effect

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fachhochschule Südschweiz

Landquart, Kanton Graubünden, 7302, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Game Ready cryocompression

Device

Cryotherapy on the coldest tolerable level and intermittend compression on the knee

Primary outcomes

  1. Change from Baseline (preoperatively) Knee and Osteoarthritis Outcome Score (KOOS) at postoperatively (4th day) and 6 weeks after surgery

    Time frame: 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

  2. Change from Baseline (preoperatively) Range of motion at postoperatively (4th day) and 6 weeks after surgery

    Time frame: preoperatively, postoperatively (4th day) and 6 weeks after surgery

    Range of motion of the knee

  3. Change from Baseline (preoperatively) Girth at postoperatively (4th day) and 6 weeks after surgery

    Time frame: preoperatively, postoperatively (4th day) and 6 weeks after surgery

    Knee girth

  4. Change from Baseline (preoperatively) Timed up and Go at postoperatively (4th day) and 6 weeks after surgery

    Time frame: preoperatively, postoperatively (4th day) and 6 weeks after surgery

    A general physical performance test used to assess mobility, balance and locomotor performance

  5. Change from Baseline (preoperatively) Skin temperature at postoperatively (4th day) and 6 weeks after surgery

    Time frame: preoperatively, postoperatively (4th day) and 6 weeks after surgery

    Skin temperature of the knee

  6. Change from Baseline (preoperatively) Visual analogue scale at postoperatively (4th day) and 6 weeks after surgery

    Time frame: preoperatively, postoperatively (4th day) and 6 weeks after surgery

    To measure the intensity of pain

  7. Change from Baseline (preoperatively) 10 Metre Walk Test at postoperatively (4th day) and 6 weeks after surgery

    Time frame: preoperatively, postoperatively (4th day) and 6 weeks after surgery

    To assess walking speed in meters per second over 10 metres

  8. Change from Baseline (first day postperatively) Patient satisfaction at each day of hospitalisation

    Time frame: each day of hospitalisation

    To measure the patient satisfaction of the cryocompression therapy from 0 to 10

  9. Consumption of morphine

    Time frame: 6 weeks after surgery

    Consumption of morphine in number of pills

  10. Length of stay

    Time frame: 6 weeks after surgery

    Length of stay in the hospital in days

Sponsors and collaborators

Lead sponsor

University of Applied Sciences and Arts of Southern Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 27, 2022
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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