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

Zimmer Biomet

Status: Invitation-only

Conditions: Clavicle Fracture; Clavicle Injury

Treatments: Device: Clavicle open reduction and internal fixation

Study type: Interventional

Funder types: Industry

Identifiers

NCT05327959

CMG2020-08T

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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98 participants in 1 patient group

Treatment Group

Experimental group

Description:

The population target is all subjects suffering clavicle fracture suitable for open reduction and internal fixation by the A.L.P.S. Clavicle Plating System in accordance with the IFU.

Treatment:

Device: Clavicle open reduction and internal fixation