Specialty: Musculoskeletal disorders, Primary sub-specialty: Elective Orthopaedic Surgery
Conditions
Interventions
Participants are randomised to one of two groups via a secure internet system utilising a simple randomisation process.
Control group: Participants receive crepe bandage and synthetic wool layer for
Sponsors
Northumbria Healthcare NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients scheduled for primary total knee arthroplasty 2. Presenting at a participating trial site 3. Aged over 18 4. Able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Unable to consent 2. History of peripheral vascular disease 3. History of peripheral neuropathy 4. History of, or current venous ulceration 5. Absent foot pulses 6. Planned same day discharge joint replacement patients 7. Revision knee arthroplasty 8. Unicondylar or patellofemoral joint knee arthroplasty 9. Regular concomitant high dose anti-coagulant medication. Patients on routine thromboprophylaxis can be included 10. Unwilling to provide informed consent 11. Lack mental capacity and therefore unlikely to comply with data collection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient reported knee function and pain is measured using the Oxford Knee Score at baseline (pre-operatively), 12 months post-operatively Substudy added 22/02/2018: Haemoglobin drop: difference between pre-op at pre-assessment or anaemia clinic and day 1 post-op levels | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient reported knee function and pain is measured using the Oxford Knee score at baseline (pre-operatively) and 6 months posy-operatively 2. Health related quality of life is measured using the EQ-5D-3L at baseline (pre-operatively), 6 and 12 months post-operatively. 3. Health related quality of life is measured using the EQ-5D-5L at baseline (pre-operatively) and 12 months post-operatively- the validity and responsiveness of EQ5D-5L will be compared against EQ5D-3L. The UK value sets for the EQ-5D-5L are currently being derived and analysis will follow the most recent EuroQol guidance. 4. Pain is measured by VAS at 10 days post-operatively, 4 weeks and 12 months post-operatively 5. Proportion of each patient group that have to return to theatre within 30 days of surgery for any reason is assessed by hospital episode statistics at 12 months post-operatively 6. Proportion of each patient group that is readmitted to hospital within 30 days of surgery for any reason is assessed using local NHS trust patient administration system (PAS) data at 12 months post-operatively 7. Proportion of each patient group that suffers a pulmonary embolism requiring in patient hospitalization within 30 days post-operatively is assessed using local NHS trust patient administration system (PAS) data at 12 months post-operatively 8. Proportion of each patient group that suffers a deep vein thrombosis requiring inpatient hospitalization within 30 days of surgery is assessed using local NHS trust patient administration system (PAS) data at 12 months post-operatively 9. Length of hospital stay will be calculated and assessed by using admission and discharge dates Substudy added 22/02/2018: 1. Haematocrit drop: difference between pre-op at pre-assessment or anaemia clinic and day 1 post-op levels 2. Transfusion rate: units of Red blood cell transfusion as inpatient 3. Length of stay: nights spent as inpatient during acute stay 4. Analgesic requirements: cumulative dose for analgesia wh | — |
Countries
United Kingdom
Contacts
Public ContactElizabeth Cook
Outcome results
None listed