Comparison of Midline With Lateral Skin Incision in Simultaneous Bilateral TKA

Skin Numbness and Kneeling Ability Clinical Trial

Official title:

Comparison of Skin Numbness and Kneeling Ability Between Midline Skin Incision Medial to Tibial Tubercle With Lateral to Tibial Tubercle Skin Incision in Simultaneous Bilateral Total Knee Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04240847
• Other study ID #: OrthoTU10
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: January 2020
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a RCT which compare skin numbness, kneeling ability and functional outcome between midline incision and lateral incision in patients undergoing simultaneous bilateral TKA

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 30, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

• The patient undergoing simultaneous bilateral TKA

• Normal skin sensation on both knees

• Informed consent

• Good cognitive function

Exclusion Criteria:

• Previous surgical wound around the knee

• Peripheral vascular disease

Related Conditions & MeSH terms

• Hypesthesia
• Skin Numbness and Kneeling Ability
• Surgical Wound

Intervention

Procedure:
• Skin incision
Skin incision on medial or lateral to tibial tubercle

Locations

Country	Name	City	State
Thailand	department of orthopaedic surgery, Faculty of medicine, Thammasat university	Khlong Luang	Pathumthani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin numbness	area of skin numbness	6 weeks, 3, 6 , 9, 12 months after surgery
Primary	Kneeling ability	Ability to kneel at 90 and 110 degrees on hard, firm and soft surface	6 weeks, 3, 6 , 9, 12 months after surgery
Secondary	Functional outcome	Modified WOMAC, Joint forgotten score	6 weeks, 3, 6 , 9, 12 months after surgery
Secondary	Knee range of motion	flexion and extension angle of knee by goniometer	6 weeks, 3, 6 , 9, 12 months after surgery
Secondary	Incision length	Skin incision length at 90 degrees knee flexion	3 months
Secondary	Complication	chronic eczema at surgical wound	6 weeks, 3, 6 , 9, 12 months after surgery