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

NCT ID: NCT05215626

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 83 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-12-12

Brief 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.

Detailed Description

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.

Conditions

Acetabulum Fracture; Pelvic Ring Fracture

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients implanted with the Zimmer Reconstruction System

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hassan Achakri

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

Azienda Ospedaliero Universitaria Senese

Siena, , Italy

Countries

Italy

Other Identifiers

MDRG2017-89MS-99T

Identifier Type: -

Identifier Source: org_study_id