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

Pelvic Ring Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05215626
• Other study ID #: MDRG2017-89MS-99T
• Status: Active, not recruiting
• Start date: August 1, 2022
• Est. completion date: August 2024

Study information

• Verified date: May 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 83
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acetabulum Fracture
• Fractures, Bone
• Pelvic Ring Fracture

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Senese	Siena

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance: Fracture healing	Performance will be assessed by analyzing fracture healing radiographically or clinically.	At last consultation visit at minimum 1 year postoperative.
Secondary	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.
Secondary	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.