Cetylated Fatty Acid for Reducing Pain After TKA

Not Applicable

Recruiting

• Conditions: Postoperative Pain; Postoperative Inflammation
• Interventions: Drug: cetylated fatty acid; Drug: Placebo

• Registration Number: NCT06300008
• Lead Sponsor: Thammasat University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-24
• Study Start: 2024-02-12
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-01
• Last Update Submitted: 2024-03-01
• Study First Posted: 2024-03-08
• Last Update Posted: 2024-03-08
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cetylated fatty acid	cetylated fatty acid	Topical cetylated fatty acid, apply 2 times/day for 6 weeks after operation
Placebo	Placebo	Topical placebo, apply 2 times/day for 6 weeks after operation

Primary Outcome Measures

Name	Time	Method
Knee skin temperature	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
Visual analog scale	post-op week12	VAS (0-100) at rest and on motion
inflammatory marker	post-op week12	ESR and CRP

Secondary Outcome Measures

Name	Time	Method
Knee Range of Motion	post-op week12	Flexion and extension angle
Thai forgotten joint score	post-op week12
Knee circumference (cm)	post-op week12	Measured by tape at midpoint of patella
Modified WOMAC	post-op week12	Total \& Subscore

Trial Locations

Locations (1)

department of orthopaedic surgery, Faculty of medicine, Thammasat university; 🇹🇭 Khlong Luang, Pathumthani, Thailand