Arthroplasty, Replacement, Knee, Osteo Arthritis Knee
Conditions
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.
Interventions
PROCEDURESharp 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.
PROCEDUREElectrocautery for all dissection
Skin incision will be made with a scalpel, but all other dissection will be performed with electrocautery.
Sponsors
Royal Infirmary of Edinburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients will be blinded to the intervention as they will be under anaesthetic whilst the procedure is being carried out.
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24hr Calculated blood loss | 1 day | Will be done using the Nadler and Gross formulae |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transfusion requirement | 2 days | If the patient requires blood transfusion or not |
| VAS (Visual Analogue Scale) pain score 24 and 48 hrs | 2 days | Patient's pain score at 24 and 48 hours post-operatively |
| Range of motion 48hrs and 6 weeks | 6 weeks | Knee range of motion in degrees at 48 hours and 6 weeks post-operatively |
| Haemoglobin drop | 1 day | Haemoglobin drop from day 1 full blood count test |
| Improvement in Oxford knee score at 12 months | 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 | 12 months | Any complications encountered |
| Length of hospital stay | 2 weeks | Length of inpatient stay in hospital |
Countries
United Kingdom
Contacts
Primary ContactChloe EH Scott, MD MSc
Backup ContactKatrina R Bell, MBChB
Outcome results
None listed