Clavicle Plate for Collarbone Fracture

Recruiting 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

98 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the ALPS Clavicle Plating System treatment for collarbone fractures?

Research shows that plating systems, like the ALPS Clavicle Plating System, generally lead to good healing and functional results for collarbone fractures, with complications occurring in about 10% of cases. Studies also highlight the importance of using the right technique and implant to avoid issues. ^{1 2 3 4 5}

Is the clavicle plate generally safe for treating collarbone fractures?

The clavicle plate is generally safe, but there can be complications like plate loosening or breaking, and refractures after plate removal. These issues occurred in about 1 out of 10 operations, mostly in complex fractures. No infections were reported in the studies. ^{1 3 6 7 8}

How does the ALPS Clavicle Plating System treatment differ from other treatments for collarbone fractures?

The ALPS Clavicle Plating System is unique because it uses a specific plating technique designed to enhance stability and reduce implant failure, particularly in unstable lateral clavicle fractures. This system may offer improved outcomes by providing orthogonal fixation, which is a method that stabilizes the bone from multiple angles, potentially leading to better healing and fewer complications compared to traditional plating methods. ^{2 3 5 9 10}

Eligibility Criteria

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.

Patient must have a signed IRB/EC approved informed consent

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

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

Treatment Details

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.

Participant Groups

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Mechanical Evaluation of 2.7- Versus 3.5-mm Plating Constructs for Midshaft Clavicle Fractures. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Anterior inferior plating versus superior plating for clavicle fracture: a meta-analysis. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

[Plating of fresh clavicular fractures. Experience with 60 operations]. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Low-contact dynamic compression plating of the clavicle. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Comparison the effects between anatomical locked plate in combination with coracoclavicular ligament reconstruction and clavicular hook plate for the treatment of Neer II b distal clavicle fractures]. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Application of a new sternoclavicular hook plate in bipolar clavicle injuries. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Anterior-inferior plate fixation of middle-third fractures and nonunions of the clavicle. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Results of anterior-inferior 2.7-mm dynamic compression plate fixation of midshaft clavicular fractures. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Biomechanical comparison of three different plate configurations for comminuted clavicle midshaft fracture fixation. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Biomechanical analysis of plating techniques for unstable lateral clavicle fractures with coracoclavicular ligament disruption (Neer type IIB). [2023]