Quote:
Fixation of Mitchell's osteotomy with bioabsorbable pins for treatment of hallux valgus deformity. Nikolaou VS, Korres D, Xypnitos F, Lazarettos J, Lallos S, Sapkas G, Efstathopoulos N.
Patients of group A had significantly less postoperative pain and returned to their previous activities earlier than patients of group B. The use of the pins did not improve the final outcome of the osteotomy. However, it allowed for faster rehabilitation due to less postoperative pain.
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Some seemingly good things about this study:
There were no significant differences in subject age and gender between groups.
The same surgeon performed all procedures
Post-op protocols were the same for both groups
Estimates of random variability were provided (SD’s) in addition to actual
P values
The surgical procedures are well described
Some seemingly not so good things:
Subjects were not randomized to groups. Subjects in group A (pins) were selected according to radiographic signs of osteoporosis. This difference between groups could be a confounding variation, eg post-op pain levels may have been lower in Group A because the bones were softer ?
Subjects were not blinded to their group allocation. Subjects in group A (pins) may have had greater expectations regarding the treatment than subjects in Group B (classic procedure). The placebo effect was not controlled for, and raises a question about the findings for subjective pain reduction, where subjects in Group A (pins) reported significantly lower pain levels at 4 wks post-op.
It would have been a good idea if the researcher who asked the questions about pain levels at follow-up was blinded to the group allocation, otherwise there could be inadvertent suggestion about how well the recovery was going.
The conclusion quoted above implies a statistically significant difference in convalescence (time to return of previous activities) between groups, which was not the case (0.059). Close though, and would be more meaningful if the effect size (d) had been calculated.
I take my hat off to those who conduct clinical research in surgery ...
Regards,
Andrew