N/A Completed N=78

PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Reconstruction System

Acetabulum Fracture · Pelvic Ring Fracture

Source: ClinicalTrials.gov NCT05215626 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2026

Primary outcomePrimary: Performance: Fracture Healing — 84; 0 Cases

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Performance: Fracture Healing	84; 0	—
SECONDARY Product Safety	68; 16	—
SECONDARY Harris Hip Score	59; 17; 7; 1	—

Eligibility Criteria

Inclusion Criteria

Patients having received the Zimmer Reconstruction System for temporary internal fixation and stabilization of fractures during the normal healing process

Exclusion Criteria

Off-label use
Patients under the age of 18
Severely comminuted fractures in which bone fragments are too small or numerous to adequately fix or maintain a reduced position
Infection
Metal sensitivity or intolerance
Severe osteopenia and/or osteoporosis, or in the presence of marked or rapid bone absorption, metabolic bone disease, cancer, or any other tumor-like condition of the bone which may compromise fixation
Sternal or spinal fractures
Anatomical location in which the device would interfere with nerves, blood vessels, or other vital structures
Patients with inadequate soft tissue coverage at the implant site

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05215626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.