Topic: Musculoskeletal disorders, Surgery
Conditions
Interventions
This feasibility study will comprise of three parts:
1. Patients due for TKR surgery will invited to take part in a pilot trial and randomised to surgery with or without a tourniquet w
Sponsors
University of Warwick
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria as of 04/05/2017: 1. Patients must be aged 18 years and over 2. Patient is undergoing primary unilateral knee replacement 3. The patient is able to give written informed consent and participate fully in the trial interventions and follow up procedures Original inclusion criteria: 1. All patients undergoing an elective primary unilateral cemented total knee replacement (TKR) under the care of four orthopaedic consultants at University Hospitals Coventry and Warwickshire (UHCW) NHS trust 2. Male and Female 3. Lower age limit 18 years
Exclusion criteria
Exclusion criteria: Exclusion criteria as of 04/05/2017: 1. Patients for whom Magnetic Resonance (MR) imaging is contraindicated due to 1.1. None compliant heart pacemaker or defibrillator or 1.2. None compliant metallic foreign body e.g. in one or both eyes or aneurysm clips in the brain or 1.3. Claustrophobia (e.g. difficulty in an elevator or telephone box) 2. Patients not suitable for a thigh tourniquet (e.g. significant peripheral vascular disease) 3. Previous participation in the SAFE-TKR Trial Original exclusion criteria: 1. Patients who lack capacity under the Mental Capacity Act 2005 2. Patients for whom Magnetic Resonance (MR) imaging is either contraindicated (heart pacemaker, metallic foreign body in one or both eyes, or who have an aneurysm clip in their brain) or not feasible because of claustrophobia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome as of 04/05/2017: Total volume of acute brain lesions detected on Magnetic Resonance (MR) brain imaging per patient, day 1 or 2 post operatively. Original primary outcome: Total volume of acute brain lesions detected on Magnetic Resonance (MR) brain imaging per patient, day 1 post operatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 08/10/2018: 1. Montreal Cognitive Assessment (MoCA) preoperatively and day 1, 2 and 7 days post operatively and 6 and 12 month post operatively. 2. Oxford Cognitive Screen (OCS) preoperatively and day 1, 2 and 7 post operatively 3. Mini-mental state examination (MMSE) scores preoperatively and on day 1, 2 and 7 post operatively 1. Knee pain is measured using the Oxford Knee Score post operatively at baseline, 1 week, 6 and 12 month 2. Thigh pain is measured using the Visual Analogue Score (VAS) for acute thigh pain at baseline, day 1, day 2 and 1 week 3. Knee pain is measured using the EQ-5D-5L at baseline, 1 week, 6 and 12 months 4. Number of symptomatic VTE events is measured by questionnaire up to 12 months post operatively 5. Surgical Complication rate is measured by questionnaire up to 12 month post operatively 6. Number of intra/post-operative blood transfusions are measured by patient notes up until discharge 7. Revision rate of the TKR prosthesis is measured by questionnaire or patient notes at 12 months 8. All-cause mortality rates are measured by patient notes or next of kin at 12 months 9. Change in haemoglobin concentration between pre-operative haemoglobin and post operative haemoglobin Previous secondary outcomes as of 04/05/2017: 1. Knee pain is measured using the Oxford Knee Score post operatively at baseline, 1 week, 6 and 12 month 2. Thigh pain is measured using the Visual Analogue Score (VAS) for acute thigh pain at baseline, day 1, day 2 and 1 week 3. Knee pain is measured using the EQ-5D-5L at baseline, 1 week, 6 and 12 months 4. Number of symptomatic VTE events is measured by questionnaire up to 12 months post operatively | — |
Countries
United Kingdom
Contacts
Public ContactPeter Wall
Outcome results
None listed