Compressive Stockings Therapy After TKA

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04434222
• Other study ID #: W759
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Compliance of Wearing of Compressive Stockings
• Total Knee Arthroplasty

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