Does Electrocautery Increase Postoperative Pain in Primary Total Knee Arthroplasty

NCT06239038 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: PGH protocal
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Osteoarthritis, Knee

Keywords

Total knee arthroplasty, Electrocautery, Scalpel, Post-operative pain, Pain score

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Calculated blood loss

  postoperative day 4

• Functional score

  follow up 2 weeks, 1,3,6 months

Study Arms (2)

scalpel group

EXPERIMENTAL

Proceed with following step 1. Using electrocautery for stop bleeding at subcutaneous tissue layer 2. In deep layer still use scalpel for Remove anterior cruciate ligament and posterior cruciate ligament 3. Soft tissue removal and synovial tissue removal 4. No patellar denervation

Procedure: total knee arthroplasty

electrocautery group

EXPERIMENTAL

Using an electrocautery in following step 1. Stop bleeding at subcutaneous tissue layer 2. Remove anterior cruciate ligament and posterior cruciate ligament 3. Bony mark for further bone cut 4. Patellar denervation 5. Soft tissue removal 6. Synovial tissue removal

Procedure: total knee arthroplasty

Interventions

total knee arthroplasty PROCEDURE

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

electrocautery group; scalpel group

Eligibility Criteria

• Age: 58 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Osteoarthritis patient (KL classification gr 2-4)
• Primary TKA
• Varus deformity \< 20 degree
• Flexion contracture \< 20 degree

You may not qualify if:

• Coagulopathy
• Platelet dysfunction
• Inflammatory arthritis
• Revision TKA

Sponsors & Collaborators

• Police General Hospital, Thailand: lead

Study Sites (1)

Police General Hospital

Pathum Wan, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain, Postoperative

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Pawut Wattanapongsiri

  orthopedic department, Police General Hospital, Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: In electrocautery group, using an electrocautery in following step 1. Stop bleeding at subcutaneous tissue layer 2. Remove anterior cruciate ligament and posterior cruciate ligament 3. Bony mark for further bone cut 4. Patellar denervation 5. Soft tissue removal 6. Synovial tissue removal In scalpel group, proceed with following step 1. Using electrocautery for stop bleeding at subcutaneous tissue layer 2. In deep layer still use scalpel for Remove anterior cruciate ligament and posterior cruciate ligament 3. Soft tissue removal and synovial tissue removal 4. No patellar denervation

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: October 11, 2021
• Primary Completion: December 31, 2023
• Study Completion: February 29, 2024
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)