NCT05327959

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

A.L.P.S. Clavicle Plating System for Clavicle Fracture Fixation Post-Market Follow-up Study (Implants and Instrumentation)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The objectives of this observational, prospective study with optional retrospective enrollment are to confirm safety, performance and clinical benefits of the A.L.P.S Clavicle Plating System and its instrumentation by analysis of fracture healing, functional outcome and adverse events. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events including re-operations. Relation of the events to implant, instrumentation and/or procedure should be specified. The performance will be evaluated by assessment of fracture/osteotomy healing and functional outcome of all enrolled study subjects.

Conditions

• Clavicle Fracture
• Clavicle Injury

Interventions

Type	Name	Description
DEVICE	Clavicle open reduction and internal fixation	Clavicle open reduction and internal fixation using the A.L.P.S. Clavicle Plating System

Timeline

• Start date: 2022-05-13
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2022-04-14
• Last updated: 2026-02-13

Locations

5 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated device study