Comment: The quality of evidence is downgraded by study limitations(lack of/unclear allocation concealment, failure to adhere to the intention-to-treat principle, selective outcome reporting) and by indirectness (differences between the outcomes of interest and those reported).
A Cochrane review [Abstract] 1 on different methods and types of intramedullary nailing for treating tibial shaft fractures in adults included 9 randomised and 2 quasi-randomised clinical trials, involving a total of 2 093 participants with 2 123 fractures. The evidence was dominated by one large multicentre trial of 1319 participants. Overall, there is insufficient evidence to draw definitive conclusions on the best type of, or technique for, intramedullary nailing. No statistically significant differences were found between the reamed and unreamed nailing groups in 'major' re-operations (66/789 versus 72/756; risk ratio (RR) 0.88, 95% confidence interval (CI) 0.64 to 1.21; 5 trials), or in the secondary outcomes of nonunion, pain, deep infection, malunion and compartment syndrome. While inconclusive, the evidence from a subgroup analysis suggests that reamed nailing is more likely to reduce the incidence of major re-operations related to non-union in closed fractures than in open fractures. Implant failure, such as broken screws, occurred less often in the reamed nailing group (35/789 versus 79/756; RR 0.42, 95% CI 0.28 to 0.61).
Ender nails when compared with an interlocking nail resulted in a higher re-operation rate (12/110 versus 3/128; RR 4.43, 95% CI 1.37 to 14.32; 2 trials) and more malunions. There were no statistically significant differences between the two devices in the other reported secondary outcomes of nonunion, deep infection, and implant failure.One trial found a lower re-operation rate for an expandable nail when compared with an interlocking nail (1/27 versus 9/26; RR 0.11, 95% CI 0.01 to 0.79). The differences between the two nails in the incidence of deep infection or neurological defects were not statistically significant.The trial comparing one distal screw versus two distal screws found no statistically significant difference in nonunion between the two groups. However, it found significantly more implant failures in the one distal screw group (13/22 versus 1/20; RR 11.82, 95% CI 1.70 to 82.38).One trial found no statistically significant differences in functional outcomes or anterior knee pain at three year follow-up between the transtendinous approach and the paratendinous approach for nail insertion.
A systematic review 2 including 19 studies (of which 5 were controlled trials) with a total of subjects was abstracted in DARE. Treatment with cast was associated with a lower rate of superficial infection. Treatment with open reduction with internal fixation was superior to treatment with cast with regard to union by twenty weeks (OR 0.21, 95% CI 0.06 to 0.68). The failure rate (late re-operation, operative procedure after treatment with a cast, and refracture) was 4% after primary treatment with cast. The median rate for re-operation after primary open reduction and internal fixation was 0.8%. The median rate of refracture after treatment with a cast was 2.3%.
Comment: The quality of evidence is downgraded by inconsistency (heterogeneity in study designs and results in different populations).
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