Clavicle Plate for Collarbone Fracture

Enrolling by invitation at 4 trial locations

Overseen By Darin A Fawley, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

Disqualifiers: Active infection, Bone quality, Neurologic conditions, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the ALPS Clavicle Plating System, a device designed to aid in healing collarbone fractures. The goal is to evaluate the safety and effectiveness of this plating system for individuals requiring surgical repair of their collarbones. The trial seeks participants with a collarbone fracture needing surgery who can understand and follow medical instructions. Those with such a fracture may find this trial suitable. As an unphased trial, it offers participants the chance to contribute to medical research and potentially benefit from innovative treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the ALPS Clavicle Plating System is safe for treating collarbone fractures?

Research has shown that the ALPS Clavicle Plating System is generally safe for treating broken collarbones. However, problems such as the plate coming loose or breaking, or the bone breaking again after plate removal, can occur. These issues are uncommon but possible.

Studies have found that using plates like the ALPS system for collarbone fractures rarely requires a second surgery for plate removal. Overall, patients usually tolerate this treatment well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ALPS Clavicle Plating System is unique because it offers a tailored approach to collarbone fractures, specifically designed for open reduction and internal fixation. Unlike traditional methods like non-surgical management with slings or standard plating techniques, this system aims to provide better anatomical alignment and stability. Researchers are excited about the potential for quicker recovery times and improved outcomes, as this system might reduce complications often seen with standard treatments.

What evidence suggests that the ALPS Clavicle Plating System is effective for collarbone fractures?

Research has shown that the ALPS Clavicle Plating System effectively fixes broken collarbones. Studies have found that this system provides strong support, aiding proper bone healing. Surgeons can adjust the plate during surgery for a better fit, reducing the risk of failure. Additionally, most patients using similar methods heal successfully and experience improved shoulder movement. This suggests that the ALPS system is a dependable choice for those needing surgery to repair a broken collarbone. ^{2 4 5 6 7}

Who Is on the Research Team?

Erin Osborn

Principal Investigator

Zimmer Biomet

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I understand my doctor's instructions and can follow the study's requirements.

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

Exclusion Criteria

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

I have issues with blood supply or bone quality/quantity.

I currently have an infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

Surgical procedure

1 visit (in-person)

Follow-up

Participants are monitored for fracture healing, functional outcome, and adverse events

12 months

Regular visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

• ALPS Clavicle Plating System

Trial Overview

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.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Zimmer Biomet

Lead Sponsor

Trials

383

Recruited

67,800+

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos

Zimmer Biomet

Chief Executive Officer since 2023

MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05327959

NCT05327959 | A.L.P.S. Clavicle Plating System PMCF

The performance will be evaluated by assessment of fracture/osteotomy healing and functional outcome of all enrolled study subjects. Official Title. A.L.P.S. ...

2.

zimmerbiomet.com

zimmerbiomet.com/content/dam/zb-corporate/en/education-resources/surgical-techniques/specialties/trauma/alps-clavicle-plating-system/ALPSClavicleSurgicalTechnique20201.pdf

A.L.P.S.® Clavicle Plating System

Temporary stabilization of the fracture through medial and lateral K-wire holes as well as the ability to contour the plate in-situ providing systematic.

3.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/ZBH/pressreleases/35734684/zimmer-biomets-clavicle-plating-system-study-a-market-game-changer/

Zimmer Biomet's Clavicle Plating System Study: A Market ...

' The study aims to confirm the safety, performance, and clinical benefits of the A.L.P.S. Clavicle Plating system, focusing on both the implant ...

4.

withpower.com

withpower.com/trial/phase-clavicle-fractures-3-2022-54ef7

Clavicle Plate for Collarbone Fracture · Info for Participants

The ALPS Clavicle Plating System is unique because it uses a specific plating technique designed to enhance stability and reduce implant failure, particularly ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8888173/

A review of outcomes after operative fixation of clavicular ...

Eighty-seven percent (n = 301) clavicle fractures were treated with a locking plate construct, 10% with hook plates, 0.3% with intramedullary fixation, and 2.6% ...

6.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/ZBH-N/pressreleases/35734684/zimmer-biomets-clavicle-plating-system-study-a-market-game-changer/

Zimmer Biomet's Clavicle Plating System Study: A Market ...

' The study aims to confirm the safety, performance, and clinical benefits of the A.L.P.S. Clavicle Plating system, focusing on both the implant ...

7.

zimmerbiomet.com

zimmerbiomet.com/en/products-and-solutions/specialties/trauma/alps-clavicle-plating-system.html

A.L.P.S® Clavicle Plating System

The A.L.P.S. Clavicle Plating System offers three families of plating solutions based on varied fracture patterns and surgeon preference.