Background:
An area of skin numbness (AON) around an incision commonly occurs following total knee arthroplasty (TKA). Mecobalamin has been shown to facilitate peripheral nerve recovery in various conditions; accordingly, the present study aimed to investigate the ameliorative effect of mecobalamin on AON following TKA, as compared with a placebo.
Methods:
This superiority study was a double-blinded, randomized controlled trial. All patients undergoing primary TKA were assessed for eligibility. Included patients were randomized to receive either mecobalamin (500 µg, twice daily) or placebo (corn starch powder; 500 µg, twice daily) for 3 months. The primary outcome was the change in the AON around the surgical site from 2 weeks to 3 months after TKA. Secondary outcomes included the rates of different adverse events, functional outcomes, and visual analogue scale patient satisfaction scores.
Results:
A total of 154 patients were enrolled, with 77 patients each in the mecobalamin and placebo groups. The mean AON among patients in the mecobalamin group was 61.6 cm
2
at baseline (2 weeks) and 29.1 cm
2
at 3 months, compared with 55.9 cm
2
and 33.2 cm
2
among patients in the placebo group, respectively. Intention-to-treat analysis showed no significant difference in the change in AON around the surgical site between the 2 groups (mean difference, 7.5; 95% confidence interval, −4.2 to 25.3; p = 0.159). The rates of adverse events, functional outcomes, and visual analogue scale patient satisfaction score were also not significantly different between groups.
Conclusions:
Mecobalamin did not demonstrate superiority over a placebo in reducing the AON around the surgical site at 3 months after primary TKA.
Level of Evidence:
Therapeutic
Level I
. See Instructions for Authors for a complete description of levels of evidence.