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

Zimmer Biomet83 enrolled

Overview

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.

The Reconstruction System is especially used to stabilize pelvic ring and acetabulum fractures. One site will be involved in this study. The aim is to include a maximum of 83 consecutive series cases who received the Zimmer Reconstruction System at the Azienda Ospedaliero Universitaria Senese (Siena, Italy) between 2010 and 2018. All potential study subjects will be required to participate to the Informed Consent process. Baseline data from the preop, intraop, immediate post-op and last consultation visit will be available in medical notes and collected retrospectively. In addition, any complications since the last consultation visit at the clinic and information about the treatment of the complications will also be collected retrospectively.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acetabulum Fracture Pelvic Ring Fracture

Eligibility

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Performance: Fracture healing

Performance will be assessed by analyzing fracture healing radiographically or clinically.

Time frame: At last consultation visit at minimum 1 year postoperative.

Secondary Outcomes

Product safety

Safety will be assessed by recording and analyzing the incidence and frequency of complications and adverse events.

Time frame: At operative evaluation, immediate post-operative evaluation and at last consultation visit at minimum 1 year postoperative.

Harris Hip Score

Clinical benefits will be assessed by evaluating the Harris Hip Score (HHS). The HHS consists of four subscales (pain, function, the absence of deformity and range of motion). The survey has 10 question items and the score will range from 0 (worst) to 100 (best).