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Comparison of Midline With Lateral Skin Incision in Simultaneous Bilateral TKA

Primary Purpose

Skin Numbness and Kneeling Ability

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Skin incision
Sponsored by
Thammasat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Numbness and Kneeling Ability focused on measuring skin incision, numbness, kneeling, total knee arthroplasty

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • department of orthopaedic surgery, Faculty of medicine, Thammasat university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Midline incision

Lateral incision

Arm Description

Skin incision at the midline, 1 cm medial to tibial tubercle

Skin incision at 1 cm lateral to tibial tubercle

Outcomes

Primary Outcome Measures

Skin numbness
area of skin numbness
Kneeling ability
Ability to kneel at 90 and 110 degrees on hard, firm and soft surface

Secondary Outcome Measures

Functional outcome
Modified WOMAC, Joint forgotten score
Knee range of motion
flexion and extension angle of knee by goniometer
Incision length
Skin incision length at 90 degrees knee flexion
Complication
chronic eczema at surgical wound

Full Information

First Posted
May 11, 2019
Last Updated
January 22, 2020
Sponsor
Thammasat University
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1. Study Identification

Unique Protocol Identification Number
NCT04240847
Brief Title
Comparison of Midline With Lateral Skin Incision in Simultaneous Bilateral TKA
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Numbness and Kneeling Ability
Keywords
skin incision, numbness, kneeling, total knee arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Midline incision
Arm Type
Active Comparator
Arm Description
Skin incision at the midline, 1 cm medial to tibial tubercle
Arm Title
Lateral incision
Arm Type
Experimental
Arm Description
Skin incision at 1 cm lateral to tibial tubercle
Intervention Type
Procedure
Intervention Name(s)
Skin incision
Intervention Description
Skin incision on medial or lateral to tibial tubercle
Primary Outcome Measure Information:
Title
Skin numbness
Description
area of skin numbness
Time Frame
6 weeks, 3, 6 , 9, 12 months after surgery
Title
Kneeling ability
Description
Ability to kneel at 90 and 110 degrees on hard, firm and soft surface
Time Frame
6 weeks, 3, 6 , 9, 12 months after surgery
Secondary Outcome Measure Information:
Title
Functional outcome
Description
Modified WOMAC, Joint forgotten score
Time Frame
6 weeks, 3, 6 , 9, 12 months after surgery
Title
Knee range of motion
Description
flexion and extension angle of knee by goniometer
Time Frame
6 weeks, 3, 6 , 9, 12 months after surgery
Title
Incision length
Description
Skin incision length at 90 degrees knee flexion
Time Frame
3 months
Title
Complication
Description
chronic eczema at surgical wound
Time Frame
6 weeks, 3, 6 , 9, 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
department of orthopaedic surgery, Faculty of medicine, Thammasat university
City
Khlong Luang
State/Province
Pathumthani
ZIP/Postal Code
066
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Midline With Lateral Skin Incision in Simultaneous Bilateral TKA

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