Does Electrocautery Increase Postoperative Pain in Primary Total Knee Arthroplasty

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Procedure: total knee arthroplasty

Detailed 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)

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10330
      • Police General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: scalpel group; Proceed with following step; Using electrocautery for stop bleeding at subcutaneous tissue layer; In deep layer still use scalpel for Remove anterior cruciate ligament and posterior cruciate ligament; Soft tissue removal and synovial tissue removal; No patellar denervation	Procedure: total knee arthroplasty; total knee arthroplasty surgery with Police Arthroplasty joint academy center(PAJAC) Subvastus Approach
Experimental: electrocautery group; Using an electrocautery in following step; Stop bleeding at subcutaneous tissue layer; Remove anterior cruciate ligament and posterior cruciate ligament; Bony mark for further bone cut; Patellar denervation; Soft tissue removal; Synovial tissue removal	Procedure: total knee arthroplasty; total knee arthroplasty surgery with Police Arthroplasty joint academy center(PAJAC) Subvastus Approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculated blood loss	Calculated blood loss using Mercuruali's formula	postoperative day 4
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

Collaborators and Investigators

• Sponsor: Police General Hospital, Thailand
• Investigators: Principal Investigator: Pawut Wattanapongsiri, orthopedic department, Police General Hospital, Thailand

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): February 29, 2024

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Total knee arthroplasty, Electrocautery, Scalpel, Post-operative pain, Pain score
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Pain, Postoperative; Osteoarthritis, Knee
• Other Study ID Numbers: PGH protocal

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