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

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.

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Key information

Conditions

Wrist Fracture Arm Injuries Fractures, Bone Humeral Fractures Proximal Humerus Fracture Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli"

Naples, Campania, 80131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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).

Secondary outcomes

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.
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".

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jul 13, 2023
Registry last updated: Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed