Cryocompression After Total Knee Arthroplasty

NCT ID: NCT05395273

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-10

Study Completion Date

2023-09-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cryotherapy Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cryocompression + standard therapy

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

Group Type EXPERIMENTAL

Game Ready cryocompression

Intervention Type DEVICE

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

Standard therapy

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Game Ready cryocompression

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

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Applied Sciences and Arts of Southern Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ron Clijsen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Applied Sciences and Arts of Southern Switzerland

Locations

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Fachhochschule Südschweiz

Landquart, Kanton Graubünden, Switzerland

Site Status

Countries

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Switzerland

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2022-D0056

Identifier Type: -

Identifier Source: org_study_id

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