Clinical trial NCT05943574: PMCF Study on the Safety, Performance and Clinical Benefits Data of the XtraFix® Small External Fixation System
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Wrist Fracture
Proximal Humerus Fracture
Keywords: Post-Market Clinical Follow-Up Study
Medical Device
Performance
Clinical Benefits
Safety
Wrist Fracture
Humerus Fracture
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2023-07-13
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Performance: Fracture healing assessed radiographically or clinically.
timeFrame: 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:
measure: Product safety will be assessed by recording the complications and adverse events.
timeFrame: 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.
measure: EuroQol five-dimensional Health Questionnaire (EQ-5D-5L)
timeFrame: At the Follow-Up Phone Call at least 1 year postoperative.
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli"
state: Campania
Study officials:
affiliation: Zimmer Biomet
name: Hassan Achakri
role: STUDY_DIRECTOR
References: