← Back to Search

Implant

Clavicle Plate for Collarbone Fracture

N/A

Waitlist Available

Research Sponsored by Zimmer Biomet

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have a clavicle fracture requiring surgical intervention and be eligible for fixation by locking plate and screws

Patient must be 18 years of age or older

Must not have

Patients with mental or neurologic conditions who are unwilling or incapable of giving proper informed consent, following postoperative care instructions

Active infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at the safety and effectiveness of a clavicle plate for treating broken collarbones.

Who is the study for?

This trial is for adults over 18 with a broken collarbone needing surgery. They must understand and follow the study's procedures and agree to all follow-ups. It's not for those unable or unwilling to consent, prisoners, pregnant or breastfeeding individuals, people unlikely to complete the follow-up, with active infections, metal sensitivities without prior testing, poor bone quality/quantity, or substance abuse issues.

What is being tested?

The A.L.P.S. Clavicle Plating System PMCF trial tests the safety and effectiveness of a clavicle plating system used in surgical repair of collarbone fractures. The focus is on how well both the implant and surgical instruments work during this procedure.

What are the potential side effects?

While specific side effects are not listed here, typical risks from such surgeries may include pain at the site of surgery, infection risk due to implantation of foreign material into the body, possible allergic reactions if there's an undetected metal sensitivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need surgery for my broken clavicle using a plate and screws.

Select...

I am 18 years old or older.

Select...

I have a fracture in one or both of my limbs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am able to understand and follow the treatment and care instructions after surgery.

Select...

I currently have an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of subjects with fracture healing

Secondary study objectives

Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeons (ASES) Shoulder Score at 12 months follow-up

Euroqol Patient Quality of life measured at 12 months follow-up (EQ-5D-5L)

Frequency and Incidence of Adverse Events (Safety)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

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.

0 / 5Eligibility criteria met