Significant Differences Between Local Reporting and Central Assessment of Radiographic Complications in a Prospective, Multicenter Study About Locking Plate Fixation of Proximal Humerus Fractures.
OBJECTIVE
To compare reporting outcomes of radiographic complications conducted by an independent review board and the responsible on-site study personnel in a multicenter study about locking plate fixation of proximal humeral fractures.


METHODS
Prospective, multicenter study; setting: 9 level I trauma centers.


METHODS
One hundred fifty patients (age 50-90) with a radiographically confirmed displaced proximal humeral fracture fixed with a locking plate were included in the study.


METHODS
All radiographic data were reevaluated by an independent review board according to predefined criteria.


METHODS
Differences in outcomes between the review board and the on-site assessment were analyzed with a paired t test. Interrater agreements between the central review board and on-site assessments were estimated by means of kappa statistics.


RESULTS
The review board revealed significantly more radiographic complications than the on-site assessment (P = 0.006), except for the complication "head necrosis." The interrater agreement was slight to moderate in all calculated categories.


CONCLUSIONS
Implementation of a complication review board using predefined criteria is recommended for clinical studies to prevent underreporting of radiographic complications by on-site assessment.
*Department of Trauma Surgery and Sports Medicine, Medical University of Innsbruck, Innsbruck, Austria;†Clinical Investigation and Documentation, AO Foundation, Dübendorf, Switzerland; and‡Institute for Biomechanics at ETH Zurich, Zurich, Switzerland.
Susanne
S
Kathrein
Alexander
A
Joeris
Franz
F
Kralinger
Michael
M
Blauth
Joerg
J
Goldhahn