Elective orthopaedic surgery Musculoskeletal Diseases Elective orthopaedic surgery
Conditions
Interventions
Patients with osteoarthritis of the knee that require a knee replacement operation are asked to take part in the study. During the clinic appointment, the surgeon tells the patient a little bit about
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 11/01/2019: 1. Unilateral primary knee replacement, including both total knee replacement (TKR) and unicompartmental knee replacement (UKR), for end-stage osteoarthritis 2. American Society of Anaesthesiologists (ASA) Grade I to III 3. Participant is willing and able to consent for themselves 4. Male or female, aged 18 years or above 5. In the Investigator’s opinion, is able and willing to comply with all trial requirements Previous participant inclusion criteria as of 26/10/2018: 1. Unilateral primary knee replacement, including both total knee replacement (TKR) or unicompartmental knee replacement (UKR), for end stage osteoarthritis 2. Willing and able consent for themselves 3. Male or female, aged 18 years or above 4. In the Investigator’s opinion, is able and willing to comply with all trial requirements. Previous participant inclusion criteria: 1. Participant is willing and able consent for themselves 2. Male or Female, aged 18 years or above 3. End stage osteoarthritis of the knee 4. In the Investigator’s opinion, is able and willing to comply with all trial requirements
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 11/01/2019: 1. Allergy or intolerance to amide-type local anaesthetics 2. Objective evidence of nerve damage in the affected lower limb 3. Rheumatoid arthritis 4. Any other significant disease, disorder or condition which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the results of the trial, or the participant’s ability to participate in the trial 5. Participants who have participated in another research trial involving an investigational product in the past 6 months 6. Participants who have significant cognitive impairment or language issues 7. Contra-lateral knee replacement within the trial or within 12 months prior to randomization Previous participant exclusion criteria as of 26/10/2018: 1. American Society of Anaesthesiologists (ASA) Grade III or above 2. Allergy or intolerance to amide type local anaesthetics 3. Objective evidence of nerve damage in the affected lower limb 4. Rheumatoid arthritis 5. Any other significant disease, disorder or condition which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the results of the trial, or the participant’s ability to participate in the trial 6. Participants who have participated in another research trial involving an investigational product in the past 6 months 7. Participants who have significant cognitive impairment or language issues 8. Contra-lateral knee replacement within the trial or within 12 months prior to randomisation Previous participant exclusion criteria: 1. American Society of Anaesthesiologists (ASA) Grade III or above 2. Allergy or intolerance to amide type local anaesthetics 3. Objective evidence of nerve damage in the affected lower limb 4. Rheumatoid arthritis 5. Any other significant disease, disorder or condition which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial. 6. Participants who have participated in another research trial involving an investigational product in the past 6 months 7. Participants who have significant cognitive impairment or language issues 8. Contra-lateral knee replacement (If the patient is receiving staged bilateral knees, they may still participate in the trial but data will only be included from the first knee)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effectiveness of liposomal bupivacaine with bupivacaine hydrochloride compared to bupivacaine hydrochloride alone on post-operative recovery is assessed both in terms of systemic recovery as well as local recovery of the operated joint. This will be measured using the quality of recovery 40 Score at 72 hours and the cumulative daily pain score at rest using VAS 0 to 72 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Other markers of recovery both in the short term and long term are measured using: 1.1. Mean pain score measured using a 0-10 VAS at: baseline and evening of surgery day 0, 1, 2 and 3 following surgery 1.2. Quality of Recovery 40 Score at baseline and evening of surgery day 0, 1, 2 and 3 following surgery 1.3. Cumulative opioid consumption over 72 hours. 1.4. Fitness for discharge against pre-defined criteria at evening of surgery day 0, 1, 2 and 3 following surgery 1.5. Functional outcome at baseline, 6 weeks, 6 months and 1 year (Oxford Knee Score, American Knee Society Score) 2. Cost effectiveness of the intervention compared with the current standard of care is measured using cost utility analysis using patient-reported quality of life as the main outcome, obtained using the EuroQol EQ-5D-5L questionnaire at baseline, 72 hours, 6 weeks, 6 months and 1 year 3. Safety is measured using serious adverse events, specifically cardiovascular or wound complications within 30 days of surgery | — |
Countries
England, United Kingdom
Contacts
Public Contact. SITU-NDORMS team
Outcome results
None listed