🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Spain / NCT05327959
Active, not recruiting Not applicable

A.L.P.S. Clavicle Plating System PMCF

NCT05327959 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2022-05-13
Last updated
2026-02-13

Condition(s) studied

Clavicle FractureClavicle Injury

Investigational drug(s) / intervention(s)

Clavicle open reduction and internal fixation

Clavicle open reduction and internal fixation: Clavicle open reduction and internal fixation using the A.L.P.S. Clavicle Plating System

Study summary

A commercially available product clinical study which aims to confirm the safety, performance, and clinical benefits to the patient of the ALPS Clavicle Plating system for both the implant itself and the instrumentation used during surgery.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Patient must be 18 years of age or older. * Patient must have a clavicle fracture requiring surgical intervention and be eligible for fixation by locking plate and screws. * Unilateral or Bilateral fractures. * Patient must be capable of understanding the doctor's explanation, following doctor's instruction, is able to and willing to complete the protocol required follow-up. * Patient must have a signed IRB/EC approved informed consent. Exclusion Criteria: * Active infection. * Patients presenting conditions including blood supply limitations, insufficient quantity or quality of bone. * Patients with mental or neurologic conditions who are unwilling or incapable of giving proper informed consent, following postoperative care instructions. * Foreign body sensitivity where material sensitivity is suspected, testing is to be completed prior to implantation of the device. * Patient is a current alcohol or drug abuser * Patient is a prisoner * Patient known to be pregnant or breast feeding * Likely problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study) * Not expected to survive the duration of the follow-up program

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Cleveland Clinic Florida Weston Florida
University of Michigan - Michigan Medicine Ann Arbor Michigan
Slocum Research & Education Foundation Eugene Oregon
University of Texas San Antonio San Antonio Texas
General Foundation of the University of Valladolid Valladolid Spain

More Zimmer Biomet trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05327959 on ClinicalTrials.gov ↗ ← All trials in Spain