Compressive Stockings Therapy After TKA

Effect of Compliance Controlled Postoperative Compressive Stockings Therapy After Total Knee Arthroplasty: a Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Total Knee Arthroplasty; Compliance of Wearing of Compressive Stockings
• Intervention / Treatment: Device: Compressive stockings

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8008
    • Universitätsklinik Balgrist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Compressive stockings group; Group receives postoperatively compressive stockings for a period of 6 weeks.	Device: Compressive stockings; Compressive stockings with built in Orthotimer Sensor
NO_INTERVENTION: Control group; The control group is treated without compressive stockings.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swelling 6 weeks postoperative	Swelling in mm	6 weeks postoperative
Swelling 12 weeks postoperative	Swelling in mm	12 weeks postoperative
Swelling 1 year postoperative	Swelling in mm	1 year postoperative
Compliance first 6 weeks postoperativ	Measured with Orthotimer sensor	First 6 weeks postoperativ

Collaborators and Investigators

• Sponsor: Balgrist University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2019
• Primary Completion (ACTUAL): May 30, 2022
• Study Completion (ACTUAL): May 30, 2022

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: June 12, 2020
• First Posted (ACTUAL): June 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 21, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: W759

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No