Active not recruitingNAINTERVENTIONAL

Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System

This study is checking how well a special plate, called the A.L.P.S. Proximal Humerus Plating System, works for people who have broken their upper arm bone (proximal humerus fracture). Doctors developed this plate to offer another surgery option, hoping it will make the broken bone stronger, allow people to move their arm better, and reduce problems with screws. This study will involve people who have had this plate put in, and researchers will follow their progress. The main goal is to make sure the plate is safe and performs as expected in real-world use.

At a glance

Status

Active not recruiting

Phase

Sponsor

Zimmer Biomet

Enrolment target

135

Start

19 Jun 2018

Estimated completion

01 Dec 2026

Osteoarthritis Rheumatoid Arthritis Post-Traumatic Arthritis Psoriatic Arthritis Proximal Humeral Fracture

What is this study about?

Imagine you've broken the top part of your upper arm bone, near your shoulder. This is called a proximal humerus fracture. Sometimes, surgery is needed to help the bone heal properly. This particular study is looking at a specific type of surgical plate that doctors might use for this kind of break. It's called the A.L.P.S. Proximal Humerus Plating System.

The plate was designed to give doctors another way to fix these fractures. The hope is that it will provide better support for the broken bone, which could help your arm heal more strongly and allow you to regain more movement. They also hope it will lower the chances of problems like screws moving out of place. Because this plate is already available for use, this study isn't testing a brand new treatment; instead, it's carefully watching how the plate works in people who have already had it fitted as part of their usual care.

Researchers will collect information from up to ten hospitals around the world. They plan to gather details on how 135 of these plates perform in people who have had this surgery. By looking at a good number of people across different locations, they can get a clearer picture of the plate's safety and effectiveness.

Key takeaways

This study looks at a surgical plate for broken upper arm bones.
It's checking the safety and performance of a plate already in use.
The goal is to improve bone strength, arm movement, and reduce screw problems.
Patients will have follow-up checks after receiving the plate.
Participation helps gather important information for future patient care.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have a break in the top part of your upper arm bone that requires surgery using a plate and screws. You might also be considered if you've tried other treatments for your arm break for up to three weeks, and they haven't worked.

It's important that you are able and willing to attend all the follow-up appointments required by the study. You'll also need to be in good general health and understand and sign a consent form, which explains everything about the study.

You would not be able to join if your surgery was delayed for more than three weeks after your injury, if your fracture was caused by a tumour, or if you are pregnant or breastfeeding. Other reasons you couldn't join include if you are a prisoner, if you currently misuse alcohol or drugs, if you have a mental or nerve condition that would make it hard to understand the study or attend follow-ups, or if you have an active infection. Conditions like very poor blood supply, being very overweight, or having very weak or poor quality bones, or if you react badly to surgical materials, would also prevent you from participating.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have a break in your upper arm bone (near your shoulder) that needs surgery?
Are you able to attend follow-up appointments?
Are you generally in good health?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you take part in this study, it means that you will be undergoing surgery to fix your upper arm bone fracture using the A.L.P.S. Proximal Humerus Plating System. The study will then involve attending follow-up appointments and assessments after your surgery to see how you are recovering and how the plate is performing. These appointments will involve doctors checking your arm, possibly taking X-rays, and asking you questions about your pain, movement, and overall well-being. The exact number and timing of these visits will be explained in detail if you are considered for the study. There are no extra medications given in this study; it's about observing how the surgery and plate perform. The total duration of your involvement will depend on the study schedule for follow-up, which typically runs for a certain period after surgery.

Potential risks and benefits

Taking part in this study means you'll receive the A.L.P.S. Proximal Humerus Plating System as part of your standard care for a broken upper arm. The main benefit is helping doctors understand more about how well this plate works, which could improve treatments for others in the future. As with any surgery, there are potential risks, such as infection, pain, or issues with healing, and these will be fully explained by your medical team. You also have the right to withdraw from the study at any time without your medical care being affected.

Locations (7)

Foundation for Orthopaedic Research & Education
Verified postcode
Tampa, United States
Sydney Adventist Hospital
Verified postcode
Wahroonga, Australia
The Research Institute of McGill University Health Centre
Verified postcode
Montreal, Canada
Korea University Anam Hospital
Verified postcode
Seoul, South Korea
Hallym University Kangnam Sacred Hearth Hospital
Verified postcode
Seoul, South Korea
Inje University Seoul Paik Hospital
Verified postcode
Seoul, South Korea
Bone and Motion Training and Research Foundation
Verified postcode
Granges-Paccot, Switzerland

Common questions

What kind of injury is this study for?

This study is for people with a specific type of break in the upper part of their arm bone, near the shoulder, called a proximal humerus fracture.

Is the A.L.P.S. plate a new, experimental treatment?

No, this plate is already available, but the study is checking how safe and effective it is in real-world use after it's been put on the market.

Will I get different treatment if I join the study?

No, you will receive the A.L.P.S. plate as part of your usual surgical treatment if your doctor decides it's the right option for you.

How long will I be involved in the study?

Your involvement will include regular follow-up visits after your surgery for a set period, which will be fully explained to you.

Can I stop participating in the study if I change my mind?

Yes, you can choose to stop participating at any time, and it will not affect the medical care you receive.