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

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

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.

Study Overview

• Status: Unknown
• Conditions: Osteo Arthritis Knee; Arthroplasty, Replacement, Knee
• Intervention / Treatment: Procedure: Sharp dissection with scalpel plus electrocautery to vessels; Procedure: Electrocautery for all dissection

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Midlothian
    • Edinburgh, Midlothian, United Kingdom, EH16 4SA
      • Royal Infirmary Of Edinburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment Group 1; Sharp dissection with scalpel plus electrocautery to vessels	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.
Active Comparator: Treatment Group 2; Electrocautery for all dissection	Procedure: Electrocautery for all dissection; Skin incision will be made with a scalpel, but all other dissection will be performed with electrocautery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24hr Calculated blood loss	Will be done using the Nadler and Gross formulae	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemoglobin drop	Haemoglobin drop from day 1 full blood count test	1 day
Transfusion requirement	If the patient requires blood transfusion or not	2 days
VAS (Visual Analogue Scale) pain score 24 and 48 hrs	Patient's pain score at 24 and 48 hours post-operatively	2 days
Range of motion 48hrs and 6 weeks	Knee range of motion in degrees at 48 hours and 6 weeks post-operatively	6 weeks
Length of hospital stay	Length of inpatient stay in hospital	2 weeks
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
Adverse events	Any complications encountered	12 months

Collaborators and Investigators

• Sponsor: Royal Infirmary of Edinburgh
• Investigators: Principal Investigator: Chloe EH Scott, MD MSc, Consultant Trauma and Orthopaedic Surgeon

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2018
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: April 10, 2018
• First Submitted That Met QC Criteria: June 15, 2018
• First Posted (Actual): June 18, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 7, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 244896

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No