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NCT06239038 Clinical Trial

Does Electrocautery Increase Postoperative Pain in Primary Total Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

Official title:
Does Electrocautery Increase Postoperative Pain in Primary Total Knee Arthroplasty: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06239038
Other study ID # PGH protocal
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date October 11, 2021
Est. completion date February 29, 2024

Study information
Verified date February 2024
Source Police General Hospital, Thailand
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Total knee arthroplasty (TKA) is a successful treatment for end-stage osteoarthritis of the knee. The main advantages of TKA are to relieve the pain of the knee, improve the knee function, restore lower limb alignment, and improve the quality of life for patients. During TKA, some surgeons prefer using a scalpel while others using electrocautery to expose the articular cavity. Whether the use of scalpel can lead to better and faster recovery after the primary TKA is still controversial. The aim of this study was to compare the clinical outcomes of using the scalpel and the electrocautery in primary TKA

Description:

A randomized controlled trial of patients underwent primary TKA between October 2021 and October 2023. The groups will be determined by using the computer to generate a randomization lists. A total 132 patients were included with 66 patients in the scalpel group, 66 patients in the electrocautery group. All patients were evaluated using primary outcome : Post-operative Visual Analog Scale (VAS) of pain, secondary outcome: estimated blood loss and Knee Injury and Osteoarthritis Outcome Score (KOOS-JR)

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 132
Est. completion date February 29, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 58 Years and older
Eligibility Inclusion Criteria: - Osteoarthritis patient (KL classification gr 2-4) - Primary TKA - Varus deformity < 20 degree - Flexion contracture < 20 degree Exclusion Criteria: - Coagulopathy - Platelet dysfunction - Inflammatory arthritis - Revision TKA

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• total knee arthroplasty
total knee arthroplasty surgery with Police Arthroplasty joint academy center(PAJAC) Subvastus Approach

Locations
Country Name City State
Thailand Police General Hospital Pathum Wan Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Police General Hospital, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative pain (visual analog scale) day 1-4 measure the Postoperative pain by using visual analog scale from 1 - 10, higher scores means worse outcome postoperative day 1-4
Secondary Calculated blood loss Calculated blood loss using Mercuruali's formula postoperative day 4
Secondary Functional score Functional score using KOOS JR score, range from 0 to 100 with a score of 0 indicating total knee disability and 100 indicating perfect knee health follow up 2 weeks, 1,3,6 months
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