Cetylated Fatty Acid for Reducing Pain After TKA

NCT ID: NCT06300008

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-12

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain Postoperative Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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cetylated fatty acid

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

Group Type EXPERIMENTAL

cetylated fatty acid

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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cetylated fatty acid

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Cetilar

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thammasat University

OTHER

Sponsor Role lead

Responsible Party

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Supakit Kanitnate

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Supakit Kanitnate, MD

Role: PRINCIPAL_INVESTIGATOR

Thammasat University Hospital

Locations

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department of orthopaedic surgery, Faculty of medicine, Thammasat university

Khlong Luang, Changwat Pathum Thani, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Supakit Kanitnate, M.D.

Role: CONTACT

66899853635

Facility Contacts

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supakit kanitnate

Role: primary

6629260000

Other Identifiers

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OrthoTU13

Identifier Type: -

Identifier Source: org_study_id

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