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CompletedNCT05395273Updated Aug 28, 2025

Cryocompression After Total Knee Arthroplasty

An interventional study of Game Ready cryocompression in Cryotherapy Effect, sponsored by University of Applied Sciences and Arts of Southern Switzerland. Completed at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2025-08-28.

Sponsored by University of Applied Sciences and Arts of Southern Switzerland · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cryotherapy Effect
03

In context

Lead sponsor

University of Applied Sciences and Arts of Southern Switzerland is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Cryocompression + standard therapy

    Participants received daily crycompression by the patient to their comfort level beside the standard therapy.

    Device: Game Ready cryocompression

  • No intervention
    Standard therapy

    The standard therapy include the common physical therapy interventions, which are normally used in the hospital.

Interventions

  • DeviceGame Ready cryocompression

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

06

What researchers measure

Primary outcomes

  1. 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

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

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

    Range of motion of the knee

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

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

    Knee girth

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

  4. 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

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

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

    Skin temperature of the knee

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

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

    To measure the intensity of pain

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

  7. 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

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

  8. 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

    Time frame: each day of hospitalisation

  9. Consumption of morphine

    Consumption of morphine in number of pills

    Time frame: 6 weeks after surgery

  10. Length of stay

    Length of stay in the hospital in days

    Time frame: 6 weeks after surgery

07

Study locations

1 site
  • Fachhochschule Südschweiz
    Landquart, Kanton Graubünden 7302, Switzerland
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 21, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05395273
Lead sponsor
University of Applied Sciences and Arts of Southern Switzerland
Responsible party
Sponsor
First posted
May 27, 2022
Start date
May 10, 2022
Primary completion
Aug 28, 2023
Completion
Sep 15, 2023
Last update
Aug 28, 2025

Study contacts

Ron Clijsen, PhD
principal investigator · University of Applied Sciences and Arts of Southern Switzerland

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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