Clinical trial NCT06239038: Does Electrocautery Increase Postoperative Pain in Primary Total Knee Arthroplasty
Official title: Does Electrocautery Increase Postoperative Pain in Primary Total Knee Arthroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Keywords: Total knee arthroplasty, Electrocautery, Scalpel, Post-operative pain, Pain score
Lead sponsor: Police General Hospital, Thailand
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 132
Sex: ALL
Minimum age (years): 58
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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

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)

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain (visual analog scale) day 1-4
timeFrame: postoperative day 1-4
Secondary outcomes:
measure: Calculated blood loss
timeFrame: postoperative day 4
measure: Functional score
timeFrame: follow up 2 weeks, 1,3,6 months
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: Police General Hospital
state: Bangkok
Study officials:
affiliation: orthopedic department, Police General Hospital, Thailand
name: Pawut Wattanapongsiri
role: PRINCIPAL_INVESTIGATOR
References: