Table III.
Characteristics | Standard procedure (N = 75) | RemovAid™ with injection (N = 77) | RemovAid™ with patch (N = 73) | Total (N = 225) | P-value† |
---|---|---|---|---|---|
Primary efficacy | |||||
Failure | 0 (0) | 21 (27) | 10 (14) | 31 (14) | <0.0001 |
Success | 75 (100) | 56 (73) | 63 (86) | 194 (86) | |
Total | 75 | 77 | 73 | 225 | |
|
|||||
Secondary efficacy | |||||
Failure | 0 (0) | 16 (21) | 6 (8) | 22 (10) | <0.0001 |
Success | 75 (100) | 61 (79) | 67 (92) | 203 (90) | |
Total | 75 | 77 | 73 | 225 | |
Tertiary efficacy | |||||
Failure | 0 (0) | 7 (9) | 3 (4) | 10 (4) | 0.017 |
Success | 75 (100) | 70 (91) | 70 (96) | 215 (96) | |
Total | 75 | 77 | 73 | 225 | |
|
Data are n (%).
Primary efficacy: Implant removed without breakage for all procedures, and additionally for RemovAid™ procedures, without additional tools (besides fingers).
Secondary efficacy: Implant removed for all procedures, and additionally for RemovAid™ procedures, with no additional tools (besides fingers).
Tertiary efficacy: Implant removed for all procedures, and additionally for RemovAid™ procedures, without the use of a scalpel.
Two participants who received the incorrect implant removal procedure are included and analysed according to the treatment they actually received (Treated Population).
Fisher’s exact test for categorical variables.
Combined efficacy due to statistical equivalence of components.