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

Launched by ZIMMER BIOMET · Apr 13, 2022

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

• 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