None listed
Conditions
Brief summary
The objective of the study is to determine whether tourniquet use during total knee replacement results in superior intra-operative and post-operative outcomes when compared to not using a tourniquet. All participants will be undergoing total knee replacement for advanced osteoarthritis. Participants will be followed up for one year following surgery. Outcomes include knee extension strength, pain and analgesia requirements, self-reported physical function and quality of life, blood loss and replacement, surgeon satisfaction with the intra-operative visual field, operation and anaesthetic time, tourniquet inflation time, complications including revision surgery, cement mantle quality, patient satisfaction, and hospital length of stay.
Interventions
All participants are undergoing total knee replacement.
Orthopaedic surgeons will complete each knee replacement, with training registrars operating under direct supervision. Each operation will last approximately 2 hours. The tourniquet will be used for the duration of the procedure and deflated immediately prior to wound closure.
Participants in the tourniquet group will have a tourniquet applied during surgery. After exsanguination of the operated limb with a rubber tube exsanguinator, th
All participants are undergoing total knee replacement. Orthopaedic surgeons will complete each knee replacement, with training registrars operating under direct supervision. Each operation will last approximately 2 hours. The tourniquet will be used for the duration of the procedure and deflated immediately prior to wound closure. Participants in the tourniquet group will have a tourniquet applied during surgery. After exsanguination of the operated limb with a rubber tube exsanguinator, the tourniquet will be inflated to 100mmHg above systolic blood pressure or 250mmHg, whichever is higher. Adherence to the intervention protocol will be monitored by the principal investigator (orthopaedic surgeon) and research coordinator.
Sponsors
Barwon Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. undergoing primary total knee replacement for primary osteoarthritis 2. > 18 years of age 3. Willing, able and mentally competent to provide informed consent
Exclusion criteria
1. Undergoing bilateral total knee replacement 2. Neurological deficit affecting operated knee 3. Rheumatoid arthritis 4. Pre-operative knee flexion <60 (degree of flexion required for strength testing) 5. Varus/valgus deformity > 15 6. Opioid tolerant (current use of oxycontin, opioid patches, or tramadol; >4 tabs panadeine forte per day) 7. Sulphonamide allergy (to allow parecoxib/celecoxib use) 8. Intolerant/allergic to oxycodone 9. Poorly controlled diabetes (HbA1C >8) (impacts on choice of dexamethasone as antiemetic) 10. Cognitively impaired (mini-mental state examination of <25/30 [18]) 11. eGFR < 60 mL/min/1.73m2 (to allow parecoxib/celecoxib use)
Outcome results
None listed