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

Primary Purpose

Osteo Arthritis Knee, Arthroplasty, Replacement, Knee

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Sharp dissection with scalpel plus electrocautery to vessels
Electrocautery for all dissection
Sponsored by
Royal Infirmary of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Infirmary of Edinburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Treatment Group 1

Treatment Group 2

Arm Description

Sharp dissection with scalpel plus electrocautery to vessels

Electrocautery for all dissection

Outcomes

Primary Outcome Measures

24hr Calculated blood loss
Will be done using the Nadler and Gross formulae

Secondary Outcome Measures

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

Full Information

First Posted
April 10, 2018
Last Updated
October 7, 2018
Sponsor
Royal Infirmary of Edinburgh
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1. Study Identification

Unique Protocol Identification Number
NCT03559478
Brief Title
Sharp Dissection Versus Monopolar Electrocautery in Primary Total Knee Arthroplasty Performed Under Tourniquet
Official Title
Sharp Dissection Versus Monopolar Electrocautery in Primary Total Knee Arthroplasty Performed Under Tourniquet: a Randomized Double Blind Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Infirmary of Edinburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Arthroplasty, Replacement, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
Patients will be blinded to the intervention as they will be under anaesthetic whilst the procedure is being carried out.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group 1
Arm Type
Active Comparator
Arm Description
Sharp dissection with scalpel plus electrocautery to vessels
Arm Title
Treatment Group 2
Arm Type
Active Comparator
Arm Description
Electrocautery for all dissection
Intervention Type
Procedure
Intervention Name(s)
Sharp dissection with scalpel plus electrocautery to vessels
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Electrocautery for all dissection
Intervention Description
Skin incision will be made with a scalpel, but all other dissection will be performed with electrocautery.
Primary Outcome Measure Information:
Title
24hr Calculated blood loss
Description
Will be done using the Nadler and Gross formulae
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Haemoglobin drop
Description
Haemoglobin drop from day 1 full blood count test
Time Frame
1 day
Title
Transfusion requirement
Description
If the patient requires blood transfusion or not
Time Frame
2 days
Title
VAS (Visual Analogue Scale) pain score 24 and 48 hrs
Description
Patient's pain score at 24 and 48 hours post-operatively
Time Frame
2 days
Title
Range of motion 48hrs and 6 weeks
Description
Knee range of motion in degrees at 48 hours and 6 weeks post-operatively
Time Frame
6 weeks
Title
Length of hospital stay
Description
Length of inpatient stay in hospital
Time Frame
2 weeks
Title
Improvement in Oxford knee score at 12 months
Description
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)
Time Frame
12 months
Title
Adverse events
Description
Any complications encountered
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chloe EH Scott, MD MSc
Phone
01312423484
Email
chloe.scott@nhslothian.scot.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Katrina R Bell, MBChB
Phone
01312423480
Email
katrinabell@doctors.org.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chloe EH Scott, MD MSc
Organizational Affiliation
Consultant Trauma and Orthopaedic Surgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chloe EH Scott, MD MSc
Phone
01312423484
Email
chloe.scott@nhslothian.scot.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No

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

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