At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Zimmer® Reconstruction System (Implant and Instrumentation) - A Retrospective Consecutive Series Study
In Brief
An observational study for Acetabulum Fracture and Pelvic Ring Fracture. Completed, enrolled 78 participants across 1 site.
Detailed Summary
The study is a monocentric, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the Reconstruction System (implants and instrumentation) when used for temporary internal fixation and stabilization of fractures during the normal healing process. The primary objective is the assessment of performance by analyzing fracture healing. The secondary objectives are the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. Subjects' outcomes will also be assessed.