Trial outcome variables, analysis metric, aggregation method and time points
Time point | |||||||
---|---|---|---|---|---|---|---|
Outcome variable | Analysis metric | Aggregation | Baseline | Day 1 postoperative | Day 2 postoperative | Week 6 postoperative | Month 12 postoperative |
VAS (0–100 mm) | Final value | Mean | × (before and after physiotherapy) | × (before and after physiotherapy) | |||
4-point pain scale | Final value | Proportion and type | × | × | |||
Total use of opiate analgesia (mg) | Final value | Mean | × | × | |||
Straight leg raise (yes/no) | Final value | Proportion | × | × | |||
Knee ROM (degrees) | Final value | Mean | × | × | |||
Timed Up and Go (impaired mobility yes/no) | Final value | Proportion | × | × | |||
Bed transfers (4-point ordinal scale) | Final value | Proportion and type | × | × | |||
Distance mobilised (metres) | Final value | Mean | × | × | |||
OKS | Final value | Mean | × | × | × | ||
EQ-5D-5L | Final value | Mean | × | × | × | ||
DN2 (7-item DN4 ordinal scale) | Final value | Proportion | × | × | × | ||
Adverse events | Final value | Proportion and type | × | × | × | × |
DN, Douleur Neuropathic Pain Score; EQ-5D-5L, EuroQol; OKS, Oxford Knee Score; ROM, range of motion; VAS, visual analogue scale.