Time point
|
Enrolment
|
BL
|
BP
|
AP
|
AI
|
12 m
|
Eligibility screen
|
x
| | | | | |
Informed consent
|
x
| | | | | |
Randomization
|
x
| | | | | |
Assessments
| | | | | | |
Demographic and biomedical
|
x
| | | | | |
Primary
| | | | | | |
Self-reported functionality
|
KOOS
|
x
|
x
|
x
|
x
|
x
|
Balance (overall)
|
Berg Balance Scale
|
x
|
x
|
x
|
x
|
x
|
Secondary
| | | | | | |
Function
|
ROM (flexion)
|
x
|
x
|
x
|
x
|
x
|
|
ROM (extension)
|
x
|
x
|
x
|
x
|
x
|
|
Strength
|
x
|
x
|
x
|
x
|
x
|
Balance (dynamic)
|
Timed Up & Go
|
x
|
x
|
x
|
x
|
x
|
(static)
|
One-leg Stand
|
x
|
x
| |
x
|
x
|
(stability)
|
Functional Reach
|
x
|
x
|
x
|
x
|
x
|
Quality of Life
|
EuroQoL
|
x
| | |
x
|
x
|
Anxiety
|
EuroQoL(5D)
|
x
|
x
| |
x
| |
Cost-effectiveness
| | | | | | |
|
Qaly
| | | | |
x
|
Patient expectations
| | | | | | |
| |
x
| | |
x
|
x
|
Interventions
| |
BL
|
BP
|
AP
|
AI
|
12 m
|
Non-active comparator
| | | |
x------x
| |
In-hospital preoperative
| |
x------x
|
x------x
| |
In-home preoperative
| |
x------x
|
x------x
| |
-
BL Baseline, BP Before procedure, AP After procedure, AI After intervention, KOOS Knee Injury Osteoartritis Outcome Score, ROM Range of Movement in degrees, Qaly Quality adjusted life year