PMCF Study on the Safety, Performance & Clinical Benefits Data of

Status Not yet recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05943574
Study type	Observational
Source	Zimmer Biomet
Contact	Andrea Singer
Phone	+41 79 318 06 55
Email	andrea.singer@zimmerbiomet.com
Status	Not yet recruiting
Phase
Start date	February 1, 2024
Completion date	August 1, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04046744` - Axillary Block in Association With Analgesic Truncal Blocks at the Elbow for Wrist Surgery.	N/A
Completed	`NCT05883410` - The Effect of Two Different Protocol in Wrist Joint Limitation After Distal Radius End Fractures	N/A
Terminated	`NCT02464280` - Tomosynthesis of Pathologies of the Chest and Skeletal Structures in Comparison to CT
Not yet recruiting	`NCT03937492` - EFFECTIVENESS OF GRADED MOTOR IMAGERY TO PREVENT CRPS IN PATIENTS WITH DISTAL RADIUS FRACTURE AFTER SURGERY	N/A
Active, not recruiting	`NCT04623346` - Orthopaedic Conservative Treatment in the Time of Covid-19 Pandemic
Completed	`NCT02802358` - Evaluation of Health and Social Interventions Aimed to Old People Discharged From Hospital After a Hip or Wrist Fracture Due to a Fall	N/A
Completed	`NCT03649542` - The Effects of Fluidotherapy® Exercise	N/A
Not yet recruiting	`NCT03316768` - Measurement of Grip and Pinch Forces Needed for Activities of Daily Living, Work and Prehistoric Stone Tool Production
Completed	`NCT02015468` - The Value of Early Mobilization and Physiotherapy Following Wrist Fractures Treated by Volar Plating	N/A
Active, not recruiting	`NCT06067074` - Cost-effectiveness, Volar Locking Plate or Non-operative Treatment Distal Radius Fracture	N/A
Terminated	`NCT01293227` - WRx Distal Radius Wrist Fracture Study	N/A
Completed	`NCT03126474` - Defining Displacement Thresholds for Surgical Intervention for Distal Radius Fractures - a Delphi Study
Active, not recruiting	`NCT04716309` - Unstable Distal Radius Fractures With Dorsal Dislocation in Patients Aged 18-64 Years. Volar Locking Plate (VLP) vs Closed Reduction and Percutaenous Pinning (CRPP).	N/A
Completed	`NCT02693288` - Comparing Efficacity of Analgesia Between Ultrasound-guided Nerve Block and Local Infiltration After Wrist Fracture Surgery	N/A
Active, not recruiting	`NCT01268397` - Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly	N/A
Recruiting	`NCT05183477` - Fast Track for Wrist and Scaphoid Fractures	N/A
Withdrawn	`NCT04527588` - Italian Translation of the Michigan Hand Outcomes Questionnaire
Completed	`NCT03555929` - Impact on Sensitivity and Motor Block Duration of an Intravenous Dexamethasone an Axillary Block With Mepivacaine.	Phase 3
Recruiting	`NCT04820114` - Proprioception and Multi Sensory Training After DRF	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms