Does Electrocautery Increase Postoperative Pain in Primary Total Knee Arthroplasty

NCT ID: NCT06239038

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-11

Study Completion Date

2024-02-29

Brief Summary

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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

Detailed Description

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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)

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

total knee arthroplasty

Intervention Type PROCEDURE

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

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

Group Type EXPERIMENTAL

total knee arthroplasty

Intervention Type PROCEDURE

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

Interventions

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total knee arthroplasty

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

58 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Police General Hospital, Thailand

OTHER

Sponsor Role lead

Responsible Party

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Pawut Wattanapongsiri

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pawut Wattanapongsiri

Role: PRINCIPAL_INVESTIGATOR

orthopedic department, Police General Hospital, Thailand

Locations

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Police General Hospital

Pathum Wan, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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PGH protocal

Identifier Type: -

Identifier Source: org_study_id

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