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

Wrist Fracture Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05943574
• Other study ID #: MDRG2017-89MS-147T
• Status: Recruiting
• Start date: May 10, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Zimmer Biomet
• Contact: Andrea Singer
• Phone: +41 79 318 06 55
• Email: andrea.singer[@]zimmerbiomet.com
• 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 91
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Proximal Humerus Fracture
• Wrist Fracture
• Wrist Fractures

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli"	Naples	Campania

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 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	Product safety will be assessed by recording the complications and adverse events.	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.
Secondary	EuroQol five-dimensional Health Questionnaire (EQ-5D-5L)	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.