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

NCT05943574 | Completed

• 1 other identifier: MDRG2017-89MS-147T
• Study Type: observational
• Target: 91
• 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 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.

Conditions

Wrist Fracture; Proximal Humerus Fracture

Keywords

Post-Market Clinical Follow-Up Study; Medical Device; Performance; Clinical Benefits; Safety; Wrist Fracture; Humerus Fracture

Outcome Measures

Primary Outcomes (1)

• Performance: Fracture healing assessed radiographically or clinically.

  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 Outcomes (2)

• Product safety will be assessed by recording the complications and adverse events.

  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)

  At the Follow-Up Phone Call at least 1 year postoperative.

Study Arms (1)

Patients who received the XtraFix® Small External Fixation 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 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli"

Naples, Campania, 80131, Italy

Location

MeSH Terms

Conditions

Wrist Fractures; Humeral Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Hassan Achakri

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: July 13, 2023
• Study Start: June 10, 2024
• Primary Completion: November 14, 2025
• Study Completion: November 14, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

IT (1)