Table 3. Complications for the Randomized Clinical Trial Cohort.
| Complication | No. (%) of patients | Risk ratioa (95% CI) | |
|---|---|---|---|
| CR (n = 84) | VLP fixation (n = 80) | ||
| Any complications | 12 (14) | 6 (8) | 0.53 (0.21-1.33) |
| Deep infection | 1 (1)b | 0 | NA |
| Additional operation | 6 (7)c | 2 (3)d | 0.35 (0.07-1.68) |
| Neuropathy | 3 (4) | 3 (4) | 1.05 (0.22-5.05) |
| Tendon irritation requiring treatment | 0 | 1 (1) | NA |
| Tendon rupture | 1 (1) | 1 (1) | 1.05 (0.07-16.50) |
| Fracture nonunion at 6 mo | 4 (5) | 0 | NA |
| Implant failure | 1 (1)b | 0 | NA |
| Complex regional pain syndrome | 2 (2) | 1 (1) | 0.53 (0.05-5.68) |
| Death | 0 | 0 | NA |
Abbreviations: CR, closed reduction and cast immobilization; NA, not applicable; VLP, volar-locking plate.
a
Risk ratios are expressed as VLP fixation vs CR.
b
These complications occurred after these participants had crossed over to VLP fixation.
c
Additional operations were for carpal tunnel release (n = 1), fracture nonunion requiring plating (n = 1), hardware failure after early crossover to surgery (n = 1), postoperative infection requiring surgical washout after crossing over to surgery (n = 1), and osteotomy at 6 months after initial treatment (n = 2).
d
Additional operations were for removal of hardware after metal allergy (n = 1) and removal of hardware after tendon irritation at 3 months after initial treatment.