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
• Status: Active, not recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Osteoarthritis, Knee
• Pain, Postoperative

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