Comparison of Midline With Lateral Skin Incision in Simultaneous Bilateral TKA

January 22, 2020 updated by: Supakit Kanitnate, Thammasat University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Pathumthani
      • Khlong Luang, Pathumthani, Thailand, 066
        • department of orthopaedic surgery, Faculty of medicine, Thammasat university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Midline incision
Skin incision at the midline, 1 cm medial to tibial tubercle
Procedure: Skin incision
Skin incision on medial or lateral to tibial tubercle
Experimental: Lateral incision
Skin incision at 1 cm lateral to tibial tubercle
Procedure: Skin incision
Skin incision on medial or lateral to tibial tubercle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin numbness
Time Frame: 6 weeks, 3, 6 , 9, 12 months after surgery
area of skin numbness
6 weeks, 3, 6 , 9, 12 months after surgery
Kneeling ability
Time Frame: 6 weeks, 3, 6 , 9, 12 months after surgery
Ability to kneel at 90 and 110 degrees on hard, firm and soft surface
6 weeks, 3, 6 , 9, 12 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional outcome
Time Frame: 6 weeks, 3, 6 , 9, 12 months after surgery
Modified WOMAC, Joint forgotten score
6 weeks, 3, 6 , 9, 12 months after surgery
Knee range of motion
Time Frame: 6 weeks, 3, 6 , 9, 12 months after surgery
flexion and extension angle of knee by goniometer
6 weeks, 3, 6 , 9, 12 months after surgery
Incision length
Time Frame: 3 months
Skin incision length at 90 degrees knee flexion
3 months
Complication
Time Frame: 6 weeks, 3, 6 , 9, 12 months after surgery
chronic eczema at surgical wound
6 weeks, 3, 6 , 9, 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

September 30, 2020

Study Registration Dates

First Submitted

May 11, 2019

First Submitted That Met QC Criteria

January 22, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OrthoTU10

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Skin Numbness and Kneeling Ability

Clinical Trials on Skin incision

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe