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

Osteo Arthritis Knee Clinical Trial

Official title:

Sharp Dissection Versus Monopolar Electrocautery in Primary Total Knee Arthroplasty Performed Under Tourniquet: a Randomized Double Blind Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03559478
• Other study ID #: 244896
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2018
• Est. completion date: April 2021

Study information

• Verified date: October 2018
• Source: Royal Infirmary of Edinburgh
• Contact: Chloe EH Scott, MD MSc
• Phone: 01312423484
• Email: chloe.scott[@]nhslothian.scot.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Sharp dissection with scalpel plus electrocautery to vessels
A scalpel will be used for dissection for TKA implantation. Bleeding vessels will be managed as encountered with electrocautery. Electrocautery will not be used for dissection.
• Electrocautery for all dissection
Skin incision will be made with a scalpel, but all other dissection will be performed with electrocautery.

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh	Midlothian

Sponsors (1)

Lead Sponsor	Collaborator
Royal Infirmary of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24hr Calculated blood loss	Will be done using the Nadler and Gross formulae	1 day
Secondary	Haemoglobin drop	Haemoglobin drop from day 1 full blood count test	1 day
Secondary	Transfusion requirement	If the patient requires blood transfusion or not	2 days
Secondary	VAS (Visual Analogue Scale) pain score 24 and 48 hrs	Patient's pain score at 24 and 48 hours post-operatively	2 days
Secondary	Range of motion 48hrs and 6 weeks	Knee range of motion in degrees at 48 hours and 6 weeks post-operatively	6 weeks
Secondary	Length of hospital stay	Length of inpatient stay in hospital	2 weeks
Secondary	Improvement in Oxford knee score at 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)	12 months
Secondary	Adverse events	Any complications encountered	12 months