Cetylated Fatty Acid for Reducing Pain After TKA

March 1, 2024 updated by: Supakit Kanitnate, Thammasat University

Efficacy of Cetylated Fatty Acid for Alleviating Postoperative Pain After Total Knee Arthroplasty: A Randomized Placebo-controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
    • Pathumthani
      • Khlong Luang, Pathumthani, Thailand, 066
        • Recruiting
        • department of orthopaedic surgery, Faculty of medicine, Thammasat university
        • Principal Investigator:
          • Nattapol Tammachote, M.D.
        • Contact:
        • Sub-Investigator:
          • Supakit Kanitnate, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cetylated fatty acid
Topical cetylated fatty acid, apply 2 times/day for 6 weeks after operation
Drug: cetylated fatty acid
use approximately 3 cm long of cream per each side of knee, then apply on the operated knee until completely absorb
Other Names:
  • Cetilar
Placebo Comparator: Placebo
Topical placebo, apply 2 times/day for 6 weeks after operation
Drug: Placebo
use approximately 3 cm long of cream per each side of knee, then apply on the operated knee until completely absorb

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scale
Time Frame: post-op Day2
VAS (0-100) at rest and on motion
post-op Day2
Visual analog scale
Time Frame: post-op week2
VAS (0-100) at rest and on motion
post-op week2
Visual analog scale
Time Frame: post-op week6
VAS (0-100) at rest and on motion
post-op week6
Visual analog scale
Time Frame: post-op week12
VAS (0-100) at rest and on motion
post-op week12
inflammatory marker
Time Frame: post-op day2
ESR and CRP
post-op day2
inflammatory marker
Time Frame: post-op week2
ESR and CRP
post-op week2
inflammatory marker
Time Frame: post-op week6
ESR and CRP
post-op week6
inflammatory marker
Time Frame: post-op week12
ESR and CRP
post-op week12
Knee skin temperature
Time Frame: post-op Day2
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
Time Frame: post-op week2
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
Time Frame: post-op week6
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
Time Frame: post-op week12
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee circumference (cm)
Time Frame: post-op Day2
Measured by tape at midpoint of patella
post-op Day2
Knee circumference (cm)
Time Frame: post-op week2
Measured by tape at midpoint of patella
post-op week2
Knee circumference (cm)
Time Frame: post-op week6
Measured by tape at midpoint of patella
post-op week6
Knee circumference (cm)
Time Frame: post-op week12
Measured by tape at midpoint of patella
post-op week12
Knee Range of Motion
Time Frame: post-op Day2
Flexion and extension angle
post-op Day2
Knee Range of Motion
Time Frame: post-op week2
Flexion and extension angle
post-op week2
Knee Range of Motion
Time Frame: post-op week6
Flexion and extension angle
post-op week6
Knee Range of Motion
Time Frame: post-op week12
Flexion and extension angle
post-op week12
Modified WOMAC
Time Frame: post-op week2
Total & Subscore
post-op week2
Modified WOMAC
Time Frame: post-op week6
Total & Subscore
post-op week6
Modified WOMAC
Time Frame: post-op week12
Total & Subscore
post-op week12
Thai forgotten joint score
Time Frame: post-op week2
post-op week2
Thai forgotten joint score
Time Frame: post-op week6
post-op week6
Thai forgotten joint score
Time Frame: post-op week12
post-op week12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Investigators

  • Principal Investigator: Supakit Kanitnate, MD, Thammasat University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 24, 2022

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OrthoTU13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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