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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 | Active Comparator | Sharp dissection with scalpel plus electrocautery to vessels |
|
| Treatment Group 2 | Active Comparator | Electrocautery for all dissection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 24hr Calculated blood loss | Will be done using the Nadler and Gross formulae | 1 day |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chloe EH Scott, MD MSc | Contact | 01312423484 | chloe.scott@nhslothian.scot.nhs.uk | |
| Katrina R Bell, MBChB | Contact | 01312423480 | katrinabell@doctors.org.uk |
| Name | Affiliation | Role |
|---|---|---|
| Chloe EH Scott, MD MSc | Consultant Trauma and Orthopaedic Surgeon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Infirmary of Edinburgh | Edinburgh | Midlothian | EH16 4SA | United Kingdom |
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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.
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Patients will be blinded to the intervention as they will be under anaesthetic whilst the procedure is being carried out.
| Electrocautery for all dissection | Procedure | Skin incision will be made with a scalpel, but all other dissection will be performed with electrocautery. |
|
| 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 |
| ID | Term |
|---|---|
| D004564 | Electrocoagulation |
| ID | Term |
|---|---|
| D002425 | Cautery |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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