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

NCT03559478 | Unknown

• 1 other identifier: 244896
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee; Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• 24hr Calculated blood loss

  Will be done using the Nadler and Gross formulae

  1 day

Secondary Outcomes (7)

• Haemoglobin drop

  1 day

• Transfusion requirement

  2 days

• VAS (Visual Analogue Scale) pain score 24 and 48 hrs

  2 days

• Range of motion 48hrs and 6 weeks

  6 weeks

• Length of hospital stay

  2 weeks

Study Arms (2)

Treatment Group 1

ACTIVE COMPARATOR

Sharp dissection with scalpel plus electrocautery to vessels

Procedure: Sharp dissection with scalpel plus electrocautery to vessels

Treatment Group 2

ACTIVE COMPARATOR

Electrocautery for all dissection

Procedure: Electrocautery for all dissection

Interventions

Sharp dissection with scalpel plus electrocautery to vessels PROCEDURE

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.

Treatment Group 1

Electrocautery for all dissection PROCEDURE

Skin incision will be made with a scalpel, but all other dissection will be performed with electrocautery.

Treatment Group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Royal Infirmary of Edinburgh: lead

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Midlothian, EH16 4SA, United Kingdom

Location

MeSH Terms

Interventions

Electrocoagulation

Intervention Hierarchy (Ancestors)

Cautery; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Chloe EH Scott, MD MSc

  Consultant Trauma and Orthopaedic Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chloe EH Scott, MD MSc

CONTACT

01312423484; chloe.scott@nhslothian.scot.nhs.uk

Katrina R Bell, MBChB

CONTACT

01312423480; katrinabell@doctors.org.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blinded to the intervention as they will be under anaesthetic whilst the procedure is being carried out.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Trauma and Orthopaedic Surgeon

Model Details: A total of 70 participants will be randomized in a 1:1 ratio to either Treatment Group 1 (sharp dissection with scalpel plus electrocautery to obvious vessels) or Treatment Group 2 (electrocautery for all dissection) using the sealed opaque envelope randomization technique.

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: June 18, 2018
• Study Start: November 1, 2018
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: October 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)