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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04434222
Other study ID # W759
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date May 30, 2022

Study information

Verified date June 2022
Source Balgrist University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date May 30, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Compressive stockings
Compressive stockings with built in Orthotimer Sensor

Locations

Country Name City State
Switzerland Universitätsklinik Balgrist Zürich

Sponsors (1)

Lead Sponsor Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Knee Function KSS 6 weeks postoperative Knee Society Score - KSS 6 weeks postoperative
Primary Knee Function KSS 12 weeks postoperative Knee Society Score - KSS 12 weeks postoperative
Primary Knee Function KSS 1 year postoperative Knee Society Score - KSS 1 year postoperative
Primary Knee Function WOMAC 6 weeks postoperative Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC 6 weeks postoperative
Primary Knee Function WOMAC 12 weeks postoperative Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC 12 weeks postoperative
Primary Knee Function WOMAC 1 year postoperative Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC 1 year postoperative
Primary Pain 6 weeks postoperative Visuelle Analogskala - VAS (1-10) 6 weeks postoperative
Primary Pain 12 weeks postoperative Visuelle Analogskala - VAS (1-10) 12 weeks postoperative
Primary Pain 1 year postoperative Visuelle Analogskala - VAS (1-10) 1 year postoperative
Secondary Swelling 6 weeks postoperative Swelling in mm 6 weeks postoperative
Secondary Swelling 12 weeks postoperative Swelling in mm 12 weeks postoperative
Secondary Swelling 1 year postoperative Swelling in mm 1 year postoperative
Secondary Compliance first 6 weeks postoperativ Measured with Orthotimer sensor First 6 weeks postoperativ
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