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Cryocompression After Total Knee Arthroplasty

U

University of Applied Sciences and Arts of Southern Switzerland

Status

Completed

Conditions

Cryotherapy Effect

Treatments

Device: Game Ready cryocompression

Study type

Interventional

Funder types

Other

Identifiers

NCT05395273
2022-D0056

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Cryocompression + standard therapy
Experimental group
Description:
Participants received daily crycompression by the patient to their comfort level beside the standard therapy.
Treatment:
Device: Game Ready cryocompression
Standard therapy
No Intervention group
Description:
The standard therapy include the common physical therapy interventions, which are normally used in the hospital.

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Ron Clijsen, PhD

Data sourced from clinicaltrials.gov

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