Abstract
Purpose: To compare the functional outcome and quality-of-life following a displaced extra-articular proximal humerus fracture treated with open reduction and locking plate fixation versus non-operative management. To provide preliminary data for a subsequent prospective clinical trial.
Method: Eligible subjects were identified through retrospective searches of a large emergency department admission database and the orthopaedic trauma database. All subjects ages 3 55 treated for a proximal humerus fracture between 2002 to 2005 were invited to participate. The Disabilities of Arm, Shoulder, and Hand (DASH), Health Utilities Index Mark 3 (HUI), Euroqol-5D (EQ-5D), and the SF-36 questionnaires were mailed to all eligible subjects. Initial radiographs were reviewed using the AO/OTA classification system. Only patients with A3, B1, B2, or B3 fractures were included.
Results: Thiry-four subjects were included: 15 were treated with sling immobilization and 19 with locked plate ORIF. The non-operative group was approximately seven years older (mean age 74 versus 67, p = 0.046). DASH scores were similar between the groups: ORIF 26.6 ± 24 and Sling 26.5 ± 20. The 95% CI surrounding the 0.01 point difference (−16.0 to 15.9) slightly exceeds the 13 point cutoff for the instrument’s measurement error (minimal detectable change). Using univariable analysis, no statistically significant differences in health state values were detected. The mean HUI value for the ORIF group was 0.68 versus 0.75 for the sling (p=0.48). Mean EQ-5D values were 0.77 for the ORIF group and 0.80 for the sling group (p=0.73). The SF-36 PCS scores were also similar between the two groups: ORIF 41.1 versus Sling 39.8 (p=0.77). When controlling for age and pre-injury function, a 0.09 point difference in HUI values was detected favouring the sling treatment (p=0.036). No differences in DASH, EQ-5D, or SF-36 PCS scores were detected using regression models.
Conclusion: The results of this small cohort suggest, for extra-articular fractures, the functional and quality of life outcomes may be similar between the two interventions. No trial comparing locked plate fixation and non-operative management has been reported. A total of 96 subjects will be needed for a prospective clinical trial comparing the two treatments (DASH difference 15, 80% power, 0.05 two-sided alpha).
Correspondence should be addressed to CEO Doug C. Thomson. Email: doug@canorth.org