Clinical trial NCT03559478: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Osteo Arthritis Knee
Arthroplasty, Replacement, Knee
Lead sponsor: Royal Infirmary of Edinburgh
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 24hr Calculated blood loss
timeFrame: 1 day
Secondary outcomes:
measure: Haemoglobin drop
timeFrame: 1 day
measure: Transfusion requirement
timeFrame: 2 days
measure: VAS (Visual Analogue Scale) pain score 24 and 48 hrs
timeFrame: 2 days
measure: Range of motion 48hrs and 6 weeks
timeFrame: 6 weeks
measure: Length of hospital stay
timeFrame: 2 weeks
measure: Improvement in Oxford knee score at 12 months
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: Midlothian
Study officials:
affiliation: Consultant Trauma and Orthopaedic Surgeon
name: Chloe EH Scott, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: