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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acetabulum Fracture; Pelvic Ring Fracture

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.

• Study Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• Italy
  • Siena, Italy, 53100
    • Azienda Ospedaliero Universitaria Senese

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Consecutive series of cases implanted with the Zimmer Reconstruction System according to Zimmer Biomet's Instruction for USE (IFU) and who meet the inclusion criteria and none of the exclusion criteria.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients implanted with the Zimmer Reconstruction System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance: Fracture healing	Performance will be assessed by analyzing fracture healing radiographically or clinically.	At last consultation visit at minimum 1 year postoperative.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Product safety	Safety will be assessed by recording and analyzing the incidence and frequency of complications and adverse events.	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).	At last consultation visit at minimum 1 year postoperative.

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Hassan Achakri, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Performance; Medical Device; Acetabulum Fracture; Pelvic Ring Fracture; Clinical Benefits; Post Market Clinical Follow Up Study
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: MDRG2017-89MS-99T

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No