Compressive Stockings Therapy After TKA

Not Applicable

Terminated

• Conditions: Total Knee Arthroplasty; Compliance of Wearing of Compressive Stockings

• Registration Number: NCT04434222
• Lead Sponsor: Balgrist University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2020-04-28
• Study First Submitted QC: 2020-06-12
• Study First Posted: 2020-06-16
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-21
• Last Update Posted: 2022-06-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Knee Function KSS 6 weeks postoperative	6 weeks postoperative	Knee Society Score - KSS
Knee Function WOMAC 12 weeks postoperative	12 weeks postoperative	Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC
Knee Function WOMAC 1 year postoperative	1 year postoperative	Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC
Knee Function KSS 12 weeks postoperative	12 weeks postoperative	Knee Society Score - KSS
Knee Function WOMAC 6 weeks postoperative	6 weeks postoperative	Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC
Pain 6 weeks postoperative	6 weeks postoperative	Visuelle Analogskala - VAS (1-10)
Pain 1 year postoperative	1 year postoperative	Visuelle Analogskala - VAS (1-10)
Knee Function KSS 1 year postoperative	1 year postoperative	Knee Society Score - KSS
Pain 12 weeks postoperative	12 weeks postoperative	Visuelle Analogskala - VAS (1-10)

Secondary Outcome Measures

Name	Time	Method
Swelling 1 year postoperative	1 year postoperative	Swelling in mm
Swelling 12 weeks postoperative	12 weeks postoperative	Swelling in mm
Compliance first 6 weeks postoperativ	First 6 weeks postoperativ	Measured with Orthotimer sensor
Swelling 6 weeks postoperative	6 weeks postoperative	Swelling in mm

Trial Locations

Locations (1)

Universitätsklinik Balgrist; 🇨🇭 Zürich, Switzerland