PMCF Study on the Safety, Performance and Clinical Benefits Data of the XtraFix® Small External Fixation System

April 20, 2026 updated by: Zimmer Biomet

Post-Market Clinical Follow-Up Study to Provide Safety, Performance and Clinical Benefits Data of the XtraFix® Small External Fixation System (Implants 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 XtraFix® Small External Fixation System (implants and instrumentation) when used to treat long bone fractures.

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

Completed

Conditions

Detailed Description

The XtraFix® Small External Fixation System is intended to be used for the treatment of appropriately sized long bone fractures (in foot, arm, wrist and hand), which account for 20% of all fractures in emergency departments and are the most common fractures in all patients under the age of 75. In this study we will only collect data on wrist and proximal humerus fractures.

One site will be involved in this study. The aim is to include a maximum of 91 consecutive series cases who received the XtraFix® Small External Fixation System at the Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli" (Naples, Italy) starting from 2019 until 2021. All potential study subjects will be required to participate in the Informed Consent Process.

Baseline data from the preoperative, intraoperative, immediate post-operative and device removal visit will be available in medical notes and collected retrospectively. During a follow up phone call at least 1 year post-operative the subject will be asked to complete a patient questionnaire and a clinical assessment of the fracture healing will be done. In addition, any complications since the last consultation visit at the clinic and information about the treatment of the complications will also be collected over the phone.

Study Type

Observational

Enrollment (Actual)

91

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Campania
      • Naples, Campania, Italy, 80131
        • Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Consecutive series of cases implanted with the XtraFix® Small External Fixation 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:

  • 18-year-old or older patients having received the XtraFix® Small External Fixation System for the treatment of long bone fractures.
  • Specifically, the system is intended for temporary stabilization of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated.
  • Revision surgeries will also be included in the study.
  • In this study we will only collect data on wrist and proximal humerus fractures.

Exclusion Criteria:

  • Off-label use
  • Active or suspected infection
  • Conditions that limit the patient's ability and/or willingness to follow instructions during the healing process
  • Inadequate skin, bone, or neurovascular status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients who received the XtraFix® Small External Fixation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance: Fracture healing assessed radiographically or clinically.
Time Frame: Radiographically at the Device Removal Visit up to 1 year postoperative or clinically at the Follow-Up Phone call at least 1 year postoperative.
When radiographs are not available, the fracture healing will be assessed clinically (pain at fracture site).
Radiographically at the Device Removal Visit up to 1 year postoperative or clinically at the Follow-Up Phone call at least 1 year postoperative.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Product safety will be assessed by recording the complications and adverse events.
Time Frame: At time of the surgery, immediate post-operative, at the Device Removal Visit up to 1 year postoperative and at the Follow-Up Phone Call at least 1 year postoperative.
Incidence and frequency of complications and adverse events will be assessed by recording them any time they occur until the Follow-up phone call at minimum 1 year postoperative.
At time of the surgery, immediate post-operative, at the Device Removal Visit up to 1 year postoperative and at the Follow-Up Phone Call at least 1 year postoperative.
EuroQol five-dimensional Health Questionnaire (EQ-5D-5L)
Time Frame: At the Follow-Up Phone Call at least 1 year postoperative.
Assessment of patient-reported outcome measures (PROMs): The EuroQol fivedimensional Health Questionnaire (EQ-5D-5L) is a generic instrument. The EQ-5D-5L is scored on a 0 to 100 mm scale. 0 mm represents "the worst..." and 100 mm represents "the best health you can imagine".
At the Follow-Up Phone Call at least 1 year postoperative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Study Director: Hassan Achakri, Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2024

Primary Completion (Actual)

November 14, 2025

Study Completion (Actual)

November 14, 2025

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

July 5, 2023

First Posted (Actual)

July 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDRG2017-89MS-147T

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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