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

NCT05215626 | Completed Results

• 1 other identifier: MDRG2017-89MS-99T
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Acetabulum Fracture; Pelvic Ring Fracture

Keywords

Acetabulum Fracture; Pelvic Ring Fracture; Medical Device; Clinical Benefits; Safety; Performance; Post Market Clinical Follow Up Study

Outcome Measures

Primary Outcomes (1)

• Performance: Fracture Healing

  Performance will be assessed by analyzing fracture healing radiographically by X-rays.

  Mean time of 1.99 years after the surgery

Secondary Outcomes (2)

• Product Safety

  Mean time of 1.99 years after the surgery

• Harris Hip Score

  Mean time of 1.99 years after the surgery

Study Arms (1)

Patients implanted with the Zimmer Reconstruction System

Patients implanted with the Zimmer Reconstruction System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Senese

Siena, 53100, Italy

Location

Limitations and Caveats

A limitation to this study is its retrospective and fully anonymized design. Due to the fully anonymized design, no further information on complications and adverse events can be collected for this study.

Results Point of Contact

• Title: Georgia Tsapara
• Organization: Zimmer Biomet

georgia.tsapara@zimmerbiomet.com

(0)79 94 54936

Study Officials

• Emilie Rohmer

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: January 31, 2022
• Study Start: August 1, 2022
• Primary Completion: June 16, 2024
• Study Completion: December 12, 2024
• Last Updated: March 10, 2026
• Results First Posted: March 10, 2026

Record last verified: 2026-02

Locations

IT (1)