Table 2 Summary of safety and efficacy study protocol
Summary of safety and study protocol | ||||||||
|---|---|---|---|---|---|---|---|---|
pre-operative entry examination | during hospital stay | out-patient clinic | ||||||
FA | ||||||||
0d | +1d | +7–11d | " + 3 we | +6we | +12 we | +12 mo | ||
Safety | S1 | x | x | x | x | x | x | x |
S2 | x | x | ||||||
Efficacy | E1 | x | x | x | x | |||
E2 | x | x | x | x | x | x | ||
E3 | x | x | x | x | ||||
E4 | x | x | x | x | x | |||
E5 | x | |||||||
S 1 = clinical examination | E 1 = KOOS/FOAS | |||||||
S 2 = interview before and after alterG training | E 2 = measuring circumference and joint mobility with neutral zero method | |||||||
E 3 = SF −36 | ||||||||
E 4 = Dynamic Gait Index (DGI) | ||||||||
E 5 = days of absence from work/registration of vocational retraining | ||||||||