Clinical outcomes for patients following unilateral total knee arthroplasty Musculoskeletal Diseases
Conditions
Interventions
Patients will be randomised to receive cryocompression therapy using either an electronic continuous cold-flow device (experimental group) or a gravity-assisted cryocompression device (control group -
Sponsors
Physiolab Technologies Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 150 Years
Inclusion criteria
Inclusion criteria: Adults scheduled to undergo TKA at Spire Methley Park Hospital (Leeds, UK)
Exclusion criteria
Exclusion criteria: 1. Revision TKA 2. Bilateral TKA 3. Cold urticaria/allergy 4. Known haematological condition that affects clotting 5. Regenerating nerves under the intended therapy area 6. Tissues affected by tuberculosis in the intended therapy area 7. Current or suspected deep vein thrombosis and/or pulmonary embolus 8. Nervous system damage causing muscle tightness with a reduced ability to stretch 9. Cognitive impairment/disabilities or communication barriers 10. Significantly impaired circulation in the intended therapy area 11. Chronic wounds near the intended therapy area 12. Malignant tumour in the affected limb or therapy area 13. Haemorrhaging tissue or any untreated haemorrhagic disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective pain using a Numerical Pain Rating Scale measured at baseline, then on post-operative days 1, 7, and 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Range-of-motion measured using a goniometer at baseline, then on postoperative days 1 and 7 2. Swelling measured using a tape measure at baseline, then on postoperative days 1 and 7 3. Patient satisfaction with the surgery measured using a 5-point Likert scale to answer the question "Overall, how would you rate the early result of your knee replacement?” on postoperative days 1, 7, and 14 4. Patient satisfaction with the cryotherapy measured using a 5-point Likert scale to answer the question “Overall, how satisfied are you with the cryotherapy treatments you have received today?” on postoperative days 1, 7, and 14 5. Ease-of-use of cryotherapy device measured using a 5-point Likert scale to answer the question “overall, how easy have you found your cryotherapy device to use?” on postoperative days 1, 7, and 14 6. Use of analgesia (including time, type, and dose) measured using data logged daily on hospital records (while in hospital) and within a data-collection pack by the patient (while at home) 7. Knee function measured using an Oxford Knee Score at baseline and on postoperative day 14 | — |
Countries
England, United Kingdom
Contacts
Public ContactJames Belsey
Outcome results
None listed