OBJECTIVE: To investigate which orthosis results in: (1) the least complications; (2) the least extensor lag; (3) the highest rates of treatment success according to the Abouna and Brown criteria for soft tissue mallet injury in adults. DATA SOURCES: Electronic databases AMED, CINAHL, Embase, Medline, PubMed, OTseeker and PEDro were searched from the earliest available until September 2014. STUDY SELECTION: Controlled trials evaluating orthosis type in conservative management of mallet injury were included. Database searching yielded 1024 potential studies, of which 7 met inclusion criteria with a total of 491 participants. DATA EXTRACTION: Data was extracted using an author designed extraction form by 1 reviewer and the accuracy assessed by a second reviewer. The PEDro scale was used to assess methodological quality. DATA SYNTHESIS: Results were pooled using a random-effects model with inverse variance methods. Dichotomous outcomes are expressed as risk ratios (RR) and 95% confidence intervals (95%CI) and continuous outcomes as standardised mean differences (SMD) and 95% CI. There is moderate quality evidence that prefabricated orthoses had 3 times the risk of skin complications when compared to all other orthoses (RR 3.17, 95% CI 1.19 to 8.43, I2 = 47%) and nearly 7 times the risk of skin complications when compared to custom thermoplastic orthoses (RR 6.72, 95% CI 1.59 to 28.46, I2 = 0%). Treatment outcomes were similar for treatment success when comparing prefabricated orthoses to custom orthoses (RR 0.99, 95% CI 0.80 to 1.22, I2 = 39%, very low quality evidence), and for extensor lag when comparing custom thermoplastic orthoses to other orthoses (SMD 0.03, 95% CI -0.29 to 0.36, I2 = 0%, moderate quality evidence). CONCLUSIONS: The prefabricated orthoses were found to increase the risk of developing skin complications compared with custom orthoses but there were no differences in treatment success, failure or extensor lag. PROSPERO DATABASE REGISTRATION NUMBER: CRD42014014154.

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