Table 4.
Severe adverse events (SAE)
| Loss of reduction/malunion warranting ORIF or corrective osteotomy | Implant removal due to malpositioning or other reason | Extensor tendon rupture/tenosynovitis | Flexor tendon rupture/tenosynovitis | Wound healing problem or infection | Carpal tunnel syndrome and/or release | Nerve injury | CRPS | Delayed uniond/ Nonunion | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Publication | C | I | C | I | C | I | C | I | C | I | C | I | C | I | C | I | C | I |
| Arora et al, 201172 | NA | NA | 0/37 | 6/36 | 0/37 | 5/36 | NA | 4/36 | NA | NA | 0/37 | 1/36 | 0/37 | 0/36 | 5/37c | 2/36c | 6/37 | 2/36 |
| Bartl et al, 201479 | 37/90a | 0/84 | 2/90a | 4/90 | 1/90 | 0/84 | 1/90 | 0/84 | 0/90 | 1/84 | 2/90 | 1/84 | 3/90b | 0/84 | 1/90c | 0/84 | 0/90 | 0/90 |
| Martinez, 201880 | NA | NA | 0/47 | 1/50 | 0/47 | 1/50 | NA | NA | 0/47 | 0/50 | 0/47 | 1/50 | NA | NA | 1/47 | 0/50 | 0/47 | 1/50 |
| Mulders et al, 201984 | 18/60a | 0/59 | 1/60 | 9/59 | 5/60 | 5/59 | NA | NA | 1/60 | 3/59 | 3/60 | 0/59 | NA | NA | 4/60 | 1/59 | 0/60 | 1/59 |
| Sirniö et al, 201985 | 1/42 | 0/38 | NA | NA | NA | NA | 0/42 | 1/38 | NA | NA | 4/42 | 1/38 | NA | NA | NA | NA | NA | NA |
| Saving et al, 201983 | 3/63 | 0/56 | 0/63 | 4/56 | 0/63 | 0/56 | 0/63 | 3/56 | 0/63 | 2/56 | 5/63 | 2/56 | 5/63e | 7/56e | 2/63 | 0/56 | NA | NA |
|
Total
Mean %f |
59/255 23.0% (3.9%g) |
0/237 0.0% |
3/297 1.0% |
24/291 8.2% |
6/297 2.0% |
11/285 3.9% |
0/195 0.0% |
7/214 3.3% |
1/260 0.4% |
6/249 2.4% |
14/339 4.1% |
6/323 1.9% |
8/190 4.2% |
7/176 4.0% |
13/297 4.3% |
3/285 1.1% |
6/234 2.6% |
4/235 1.7% |
Note. ORIF, open reduction internal fixation; CRPS, complex regional pain syndrome; C, control; I, intervention; VLP, volar locking plates.
aAll were initially treated non-operatively but later operated with VLP due to loss of alignment during non-operative treatment. bAll neurological complications occurred after conversion in the surgical arm (two lesions of sensory radial nerve branches, one median nerve hypoesthesia). cCRPS type 1. dUnion not observed after six weeks in plain X-rays. eNerve numbness. fMean (%) of all complications. gCorrective osteotomies outside the initial treatment.