An interventional study of Sharp dissection with scalpel plus electrocautery to vessels and Electrocautery for all dissection in Osteo Arthritis Knee and Arthroplasty, Replacement, Knee, sponsored by Royal Infirmary of Edinburgh. Status unknown at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2018-10-09.
Sponsored by Royal Infirmary of Edinburgh · Not applicable, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 70 is close to the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Royal Infirmary of Edinburgh is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Sharp dissection with scalpel plus electrocautery to vessels
Procedure: Sharp dissection with scalpel plus electrocautery to vessels
Electrocautery for all dissection
Procedure: Electrocautery for all dissection
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.
Skin incision will be made with a scalpel, but all other dissection will be performed with electrocautery.
24hr Calculated blood loss
Will be done using the Nadler and Gross formulae
Time frame: 1 day
Haemoglobin drop
Haemoglobin drop from day 1 full blood count test
Time frame: 1 day
Transfusion requirement
If the patient requires blood transfusion or not
Time frame: 2 days
VAS (Visual Analogue Scale) pain score 24 and 48 hrs
Patient's pain score at 24 and 48 hours post-operatively
Time frame: 2 days
Range of motion 48hrs and 6 weeks
Knee range of motion in degrees at 48 hours and 6 weeks post-operatively
Time frame: 6 weeks
Length of hospital stay
Length of inpatient stay in hospital
Time frame: 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)
Time frame: 12 months
Adverse events
Any complications encountered
Time frame: 12 months
Plan to share: No
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This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Royal Infirmary of Edinburgh