Sharp Dissection Versus Monopolar Electrocautery in Primary Total Knee Arthroplasty Performed Under Tourniquet

Not Applicable

• Conditions: Osteo Arthritis Knee; Arthroplasty, Replacement, Knee
• Interventions: Procedure: Electrocautery for all dissection; Procedure: Sharp dissection with scalpel plus electrocautery to vessels

• Registration Number: NCT03559478
• Lead Sponsor: Royal Infirmary of Edinburgh

Brief Summary

This study compares the use of sharp dissection with diathermy for the approach to a total knee replacement. Half of the patients will be randomly assigned each intervention.

Detailed Description

The approach to the knee to carry out a total knee replacement (TKR) can either be carried out using a scalpel, sharp dissection, or using an electric current to divide tissue, monopoly electrocautery. Reducing blood loss is important. Blood loss can result in anaemia, which has a number of effects including shortness of breath, chest pain and lethargy. Blood loss into a newly replaced knee can also result in pain and stiffness in the joint. Total knee replacements are routinely carried out with a tourniquet inflated, which reduces the blood flow into to leg during the operation. Diathermy is applied to areas of bleeding to stop them from doing so during operations. With the tourniquet inflated, some areas that would bleed when this was deflated may not be noticed and continue to bleed. Using diathermy for the approach would be expected to reduce this bleeding compared to using a scalpel.

Study Timeline

• Study First Submitted: 2018-04-10
• Study First Submitted QC: 2018-06-15
• Study First Posted: 2018-06-18
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-07
• Last Update Posted: 2018-10-09
• Study Start: 2018-11
• Primary Completion: 2021-04
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Primary knee osteoarthritis requiring TKA (total knee arthroplasty)
• Planned for cruciate retaining prosthesis without patella resurfacing
• Patient is able to give informed consent
• Patient resides locally and will be available for follow up

Exclusion Criteria

• Cardiac pacemaker
• Inflammatory arthropathy
• Tourniquet contraindicated
• Thrombophilia/haemoglobinopathy
• Spinal anaesthetic not possible

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group 2	Electrocautery for all dissection	Electrocautery for all dissection
Treatment Group 1	Sharp dissection with scalpel plus electrocautery to vessels	Sharp dissection with scalpel plus electrocautery to vessels

Primary Outcome Measures

Name	Time	Method
24hr Calculated blood loss	1 day	Will be done using the Nadler and Gross formulae

Secondary Outcome Measures

Name	Time	Method
Haemoglobin drop	1 day	Haemoglobin drop from day 1 full blood count test
Length of hospital stay	2 weeks	Length of inpatient stay in hospital
Range of motion 48hrs and 6 weeks	6 weeks	Knee range of motion in degrees at 48 hours and 6 weeks post-operatively
Transfusion requirement	2 days	If the patient requires blood transfusion or not
VAS (Visual Analogue Scale) pain score 24 and 48 hrs	2 days	Patient's pain score at 24 and 48 hours post-operatively
Improvement in Oxford knee score at 12 months	12 months	Oxford Knee Score, designed to assess function and pain after total knee replacement. Scored from 0 (severe knee symptoms with functional limitation) to 60 (absence of pain and limitations)
Adverse events	12 months	Any complications encountered

Trial Locations

Locations (1)

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, Midlothian, United Kingdom