Cetylated Fatty Acid for Reducing Pain After TKA

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06300008
• Other study ID #: OrthoTU13
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Thammasat University
• Contact: Supakit Kanitnate, M.D.
• Phone: 66899853635
• Email: naypeng[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Pain, Postoperative
• Postoperative Inflammation
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Thailand	department of orthopaedic surgery, Faculty of medicine, Thammasat university	Khlong Luang	Pathumthani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale	VAS (0-100) at rest and on motion	post-op Day2
Primary	Visual analog scale	VAS (0-100) at rest and on motion	post-op week2
Primary	Visual analog scale	VAS (0-100) at rest and on motion	post-op week6
Primary	Visual analog scale	VAS (0-100) at rest and on motion	post-op week12
Primary	inflammatory marker	ESR and CRP	post-op day2
Primary	inflammatory marker	ESR and CRP	post-op week2
Primary	inflammatory marker	ESR and CRP	post-op week6
Primary	inflammatory marker	ESR and CRP	post-op week12
Primary	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
Primary	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
Primary	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
Primary	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	Knee circumference (cm)	Measured by tape at midpoint of patella	post-op Day2
Secondary	Knee circumference (cm)	Measured by tape at midpoint of patella	post-op week2
Secondary	Knee circumference (cm)	Measured by tape at midpoint of patella	post-op week6
Secondary	Knee circumference (cm)	Measured by tape at midpoint of patella	post-op week12
Secondary	Knee Range of Motion	Flexion and extension angle	post-op Day2
Secondary	Knee Range of Motion	Flexion and extension angle	post-op week2
Secondary	Knee Range of Motion	Flexion and extension angle	post-op week6
Secondary	Knee Range of Motion	Flexion and extension angle	post-op week12
Secondary	Modified WOMAC	Total & Subscore	post-op week2
Secondary	Modified WOMAC	Total & Subscore	post-op week6
Secondary	Modified WOMAC	Total & Subscore	post-op week12
Secondary	Thai forgotten joint score		post-op week2
Secondary	Thai forgotten joint score		post-op week6
Secondary	Thai forgotten joint score		post-op week12