Compressive Stockings Therapy After TKA

NCT ID: NCT04434222

Last Updated: 2022-06-27

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

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2022-05-30

Brief Summary

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Due to swelling after total knee arthroplasty, postoperative mobilization and training is impeded in addition to higher pain level in patients. With postoperative compressive stockings to prevent oedema, haematoma and postoperative pain we would like to investigate if compressive stockings reduce postoperative swelling and pain and furthermore improve mobilization and knee function.

In this randomized controlled trial, 88 patients are randomized in two groups. One group receives postoperatively compressive stockings for a period of 6 weeks. The control group is treated without compressive stockings. The patients compressive stockings wearing compliance is controlled with a temperature sensitive sensor. The patients will be informed about the implantation of the sensor.

Outcome measures are knee- calf- and ankle swelling in mm, pain, WOMAC and KSS score preoperatively and at 12 weeks, 12 months and 24 months.

Detailed Description

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Conditions

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Compliance of Wearing of Compressive Stockings Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Compressive stockings group

Group receives postoperatively compressive stockings for a period of 6 weeks.

Group Type ACTIVE_COMPARATOR

Compressive stockings

Intervention Type DEVICE

Compressive stockings with built in Orthotimer Sensor

Control group

The control group is treated without compressive stockings.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Compressive stockings

Compressive stockings with built in Orthotimer Sensor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients receiving a total knee replacement
* Written consent of the study participant

Exclusion Criteria

* Peripheral arterial disease II, III or IV
* Diabetes mellitus
* Systemic inflammatory diseases
* Benign or malignant neoplasms
* Revision interventions
* Right heart failure
* pulmonary edema
* Open / chronic skin lesions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Balgrist University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitätsklinik Balgrist

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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W759

Identifier Type: -

Identifier Source: org_study_id

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