NCT04240847

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2019

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1.4 years

First QC Date

May 11, 2019

Last Update Submit

January 22, 2020

Conditions

Skin Numbness and Kneeling Ability

Keywords

skin incisionnumbnesskneelingtotal knee arthroplasty

Outcome Measures

Primary Outcomes (2)

  • Skin numbness

    area of skin numbness

    6 weeks, 3, 6 , 9, 12 months after surgery

  • 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 Outcomes (4)

  • Functional outcome

    6 weeks, 3, 6 , 9, 12 months after surgery

  • Knee range of motion

    6 weeks, 3, 6 , 9, 12 months after surgery

  • Incision length

    3 months

  • Complication

    6 weeks, 3, 6 , 9, 12 months after surgery

Study Arms (2)

Midline incision

ACTIVE COMPARATOR

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

Procedure: Skin incision

Lateral incision

EXPERIMENTAL

Skin incision at 1 cm lateral to tibial tubercle

Procedure: Skin incision

Interventions

Skin incisionPROCEDURE

Skin incision on medial or lateral to tibial tubercle

Lateral incisionMidline incision

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient undergoing simultaneous bilateral TKA
  • Normal skin sensation on both knees
  • Informed consent
  • Good cognitive function

You may not qualify if:

  • Previous surgical wound around the knee
  • Peripheral vascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

department of orthopaedic surgery, Faculty of medicine, Thammasat university

Khlong Luang, Changwat Pathum Thani, 066, Thailand

Location

MeSH Terms

Conditions

Hypesthesia

Condition Hierarchy (Ancestors)

Somatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Membership

Study Record Dates

First Submitted

May 11, 2019

First Posted

January 27, 2020

Study Start

September 1, 2018

Primary Completion

February 1, 2020

Study Completion

September 30, 2020

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)