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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

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

NCT ID

NCT04240847

First Posted

May 11, 2019

Last Updated

January 22, 2020

Sponsor

Thammasat University

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

Studies a U.S. FDA-regulated Device Product

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

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

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Comparison of Midline With Lateral Skin Incision in Simultaneous Bilateral TKA

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