ClinicalTrials.gg
Status unknownNCT04240847Updated Jan 27, 2020

Comparison of Midline With Lateral Skin Incision in Simultaneous Bilateral TKA

An interventional study of Skin incision in Skin Numbness and Kneeling Ability, sponsored by Thammasat University. Status unknown at 1 site in Thailand. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-01-27.

Sponsored by Thammasat University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Sep 2018, registered May 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
45 Years to 85 Years
Sex
All
01

Study 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

02

Conditions studied

  • Skin Numbness and Kneeling Ability

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Keywords

  • skin incision
  • numbness
  • kneeling
  • total knee arthroplasty
03

In context

Hypesthesia

47 studies on the registry are indexed under Hypesthesia; 12 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 43 interventional studies indexed under Hypesthesia.

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Lead sponsor

Thammasat University is the lead sponsor of 85 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Previous surgical wound around the knee
  • Peripheral vascular disease
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Midline incision

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

    Procedure: Skin incision

  • Experimental
    Lateral incision

    Skin incision at 1 cm lateral to tibial tubercle

    Procedure: Skin incision

Interventions

  • ProcedureSkin incision

    Skin incision on medial or lateral to tibial tubercle

06

What researchers measure

Primary outcomes

  1. Skin numbness

    area of skin numbness

    Time frame: 6 weeks, 3, 6 , 9, 12 months after surgery

  2. Kneeling ability

    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 outcomes

  1. Functional outcome

    Modified WOMAC, Joint forgotten score

    Time frame: 6 weeks, 3, 6 , 9, 12 months after surgery

  2. Knee range of motion

    flexion and extension angle of knee by goniometer

    Time frame: 6 weeks, 3, 6 , 9, 12 months after surgery

  3. Incision length

    Skin incision length at 90 degrees knee flexion

    Time frame: 3 months

  4. Complication

    chronic eczema at surgical wound

    Time frame: 6 weeks, 3, 6 , 9, 12 months after surgery

07

Study locations

1 site
  • department of orthopaedic surgery, Faculty of medicine, Thammasat university
    Khlong Luang, Pathumthani 066, Thailand
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04240847
Lead sponsor
Thammasat University
Responsible party
Supakit Kanitnate (Membership, Thammasat University) — Principal investigator
First posted
Jan 27, 2020
Start date
Sep 1, 2018
Primary completion
Feb 1, 2020 (estimated)
Completion
Sep 30, 2020 (estimated)
Last update
Jan 27, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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