Advertisement for orthosearch.org.uk
Orthopaedic Proceedings Logo

Receive monthly Table of Contents alerts from Orthopaedic Proceedings

Comprehensive article alerts can be set up and managed through your account settings

View my account settings

Visit Orthopaedic Proceedings at:

Loading...

Loading...

Full Access

Trauma

THE IMPLANT IS ALWAYS GUILTY-DIFFERENCES IN COMPLICATION ASSESSMENT BETWEEN TREATING SURGEONS AND CENTRAL REVIEW

International Society for Fracture Repair (ISFR)



Abstract

Introduction

Complication reporting and assessment is an important part of orthopaedic trials assessing new technologies. Because the reliability of the assessment by the treating surgeon compared to central review is still unknown, it was quantified in this study and possible patterns were identified.

Materials and methods

176 patients with trochanteric fractures, treated with a trochanteric nail, were included in a prospective multicenter study. Surgeons were encouraged to report honestly every single potential complication, to rate severity, most likely cause, relation to implant, and to report the outcome of the complication. After 1-yr follow-up, 3 experienced orthopedic surgeons reassessed independently the same variables (agreement determined using kappa coefficient). Discrepancies were resolved by consensus.

Results

Surgeons rated sig. fewer complications as severe than central reviewers (88 complications: 59% mild, 27% moderate, and 14% severe vs. 47% mild, 26% moderate, and 27% severe, p<0.001, kappa 0.47). Surgeons attributed more complications to the tested implant (10 vs. 0 by reviewers); in contrast, reviewers defined more complications as unlikely related to the implant (21 vs. 10 by surgeons) but attributed more complications to surgery/surg.technique (12 vs. 8).

Discussion

The analysis revealed significant differences in the complication assessment between treating surgeons and central review and highlight the need for central complication assessment.