Cryocompression After Total Knee Arthroplasty

NCT05395273 | Completed DMC

• 1 other identifier: 2022-D0056
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cryotherapy Effect

Outcome Measures

Primary Outcomes (10)

• 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

• 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

Study Arms (2)

Cryocompression + standard therapy

EXPERIMENTAL

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

Device: Game Ready cryocompression

Standard therapy

NO INTERVENTION

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

Interventions

Game Ready cryocompression DEVICE

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

Cryocompression + standard therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent
• Diagnosed Arthritis of the Knee
• Planned implantation of a primary total knee arthroplasty by the Regionalspital Surselva AG

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Applied Sciences and Arts of Southern Switzerland: lead

Study Sites (1)

Fachhochschule Südschweiz

Landquart, Kanton Graubünden, 7302, Switzerland

Location

Study Officials

• Ron Clijsen, PhD

  University of Applied Sciences and Arts of Southern Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 27, 2022
• Study Start: May 10, 2022
• Primary Completion: August 28, 2023
• Study Completion: September 15, 2023
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)