Knee Osteoarthritis
Conditions
Keywords
Bilateral, staged, simultaneous
Brief summary
The purpose of this study is to assist surgeons and patients in answering the question "Should I have both knees replaced at the same time, or should I just do one and wait to do the second one?"
Detailed description
This is a multi-center randomized controlled trial of 224 patients in order to clearly delineate differences in post-operative outcomes and the trajectory of recovery between simultaneous and staged bilateral KA. The primary outcome measure is difference in generic health related quality of life between the two groups measured 1 year following surgery. Secondary outcome measures include differences in joint specific scores, time off work, satisfaction and costs. This trial will inform patients and clinicians about differences in recovery, function and efficacy of the procedure to aid in the selection of treatment pathway to best suit the patient.
Interventions
PROCEDURESimultaneous Knee Arthroplasty (UKA)
Patient will have both knees completed under one anesthetic.
PROCEDUREStaged Knee Arthroplasty (UKA)
Patient will have knees completed under 2 anesthetics.
Sponsors
Orthopaedic Innovation Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomized to either simultaneous or staged bilateral KA procedures using randomly generated numbers permuted in blocks of 10.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients considering bilateral knee arthroplasty * Patients must sign the consent form * Patients must be willing to complete the study questionnaires for the duration of the study
Exclusion criteria
* Patients who require simultaneous bilateral knee replacement surgery in order to manage significant bilateral flexion or valgus knee contractures where staged procedures may result in suboptimal outcomes by increasing the risk of post-operative flexion contracture in the "first replaced" knee * patients who are unable to complete the questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Veterans Rand 12-item Health Survey Score (VR-12) | 1 Year | The VR-12 is a 12-item questionnaire corresponding to eight principal physical and mental health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health; patient-reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Joint function (Oxford-12 knee score) | Pre-operative, 6 months, 12 months, 18 months, 24 months | The Oxford Knee Score (OKS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option (0-4). A total of the 12 items will indicated the joint function; lower total score = poorer function. |
| Return to work | Pre-operative, 6 months, 12 months, 18 months, 24 months | Assessment of ability to return to work and time away from work following surgery. |
| Patient satisfaction | 6 months, 12 months, 18 months, 24 months | Evaluate change in patient-reported satisfaction using a Likaert scale; 1=Very Satisfied to 5=Very Unsatisfied. |
| Complications | Intraoperative, 6 months, 12 months, 18 months, 24 months | Evaluation type and frequency of complication (adverse events). |
| Hospital stay | Up to 1 week | Number of days in hospital |
| Transfusion rate | Up to 1 week | Number of unit transfused during hospital stay. |
| Costs of knee replacement surgery | Up to 1 week | An attempt to calculate costs of surgery using length of stay data to calculate cost between Simultaneous vs Staged procedures. Length of stay will be calculated in days/hours. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATOREric R. Bohm, MD
University of Manitoba
Outcome results
None listed