NCT06300008

Brief Summary

To compare efficacy of cetylated fatty acid with placebo for reducing postoperative pain after unilateral TKA. The hypothesis is topical cetylated fatty acid can mitigate postoperative pain after TKA.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 12, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

November 24, 2022

Last Update Submit

March 1, 2024

Conditions

Postoperative PainPostoperative Inflammation

Keywords

Cetylated fatty acidTKAPostoperative painInflammation

Outcome Measures

Primary Outcomes (12)

  • Visual analog scale

    VAS (0-100) at rest and on motion

    post-op Day2

  • Visual analog scale

    VAS (0-100) at rest and on motion

    post-op week2

  • Visual analog scale

    VAS (0-100) at rest and on motion

    post-op week6

  • Visual analog scale

    VAS (0-100) at rest and on motion

    post-op week12

  • inflammatory marker

    ESR and CRP

    post-op day2

  • inflammatory marker

    ESR and CRP

    post-op week2

  • inflammatory marker

    ESR and CRP

    post-op week6

  • inflammatory marker

    ESR and CRP

    post-op week12

  • Knee skin temperature

    evaluated by digital infrared thermometer at 4 different locations on the anterior aspect of the knee independently (superomedial, superolateral, inferomedial, inferolateral borders of the patella) compared with the contralateral knee

    post-op Day2

  • Knee skin temperature

    evaluated by digital infrared thermometer at 4 different locations on the anterior aspect of the knee independently (superomedial, superolateral, inferomedial, inferolateral borders of the patella) compared with the contralateral knee

    post-op week2

  • Knee skin temperature

    evaluated by digital infrared thermometer at 4 different locations on the anterior aspect of the knee independently (superomedial, superolateral, inferomedial, inferolateral borders of the patella) compared with the contralateral knee

    post-op week6

  • Knee skin temperature

    evaluated by digital infrared thermometer at 4 different locations on the anterior aspect of the knee independently (superomedial, superolateral, inferomedial, inferolateral borders of the patella) compared with the contralateral knee

    post-op week12

Secondary Outcomes (14)

  • Knee circumference (cm)

    post-op Day2

  • Knee circumference (cm)

    post-op week2

  • Knee circumference (cm)

    post-op week6

  • Knee circumference (cm)

    post-op week12

  • Knee Range of Motion

    post-op Day2

  • +9 more secondary outcomes

Study Arms (2)

cetylated fatty acid

EXPERIMENTAL

Topical cetylated fatty acid, apply 2 times/day for 6 weeks after operation

Drug: cetylated fatty acid

Placebo

PLACEBO COMPARATOR

Topical placebo, apply 2 times/day for 6 weeks after operation

Drug: Placebo

Interventions

cetylated fatty acidDRUG

use approximately 3 cm long of cream per each side of knee, then apply on the operated knee until completely absorb

Also known as: Cetilar
cetylated fatty acid
PlaceboDRUG

use approximately 3 cm long of cream per each side of knee, then apply on the operated knee until completely absorb

Placebo

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50-80 years
  • Osteoarthritic knee patients underwent unilateral primary TKA
  • Participants understand and consent to the protocol of the trial

You may not qualify if:

  • Inflammatory knee arthritis
  • Previous knee surgery or trauma
  • Previous knee infection
  • Skin problem around the knee such as eczema, psoriasis, wound infection
  • Allergy to studied drug

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

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativeInflammation

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Supakit Kanitnate, MD

    Thammasat University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Supakit Kanitnate, M.D.

CONTACT

66899853635naypeng@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

November 24, 2022

First Posted

March 8, 2024

Study Start

February 12, 2024

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

March 8, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)