RecruitingOBSERVATIONAL

Evaluate the Continued Safety and Performance of the Foot and Ankle Products

This study aims to check the ongoing safety and performance of various foot and ankle products made by Arthrex. These medical devices are used in surgeries for a range of conditions, including flat feet (hyperpronated foot), bunions, broken bones, and ankle stabilization. We want to understand how well these products continue to help patients after their operation. Doctors will look at how your foot feels and moves, and you'll be asked to fill out questionnaires about your pain and daily activities. This helps us ensure the products are effective and safe for people needing foot and ankle surgery across the UK, improving future care for similar conditions.

At a glance

Status

Recruiting

Sponsor

Arthrex, Inc.

Enrolment target

700

Start

01 Dec 2020

Estimated completion

31 Dec 2027

Hyperpronated Foot Reconstruction Surgeries of the Foot Fixation of Fractures and Fusion (Bunionectomy Osteotomies) of the Foot/Ankle Fixation of Small Bone Fragments of the Foot/Ankle Lisfranc Arthrodesis Mono or Bi-cortical Osteotomies in the Forefoot First Metatarsophalangeal Arthrodesis Akin Osteotomy Midfoot and Hindfoot Arthrodeses or Osteotomies Fixation of Osteotomies for Hallux Valgus Treatment (Scarf and Chevron)Arthrodesis of the Metatarsocuneiform Joint to Reposition and Stabilize Metatarsus Primus Varus Osteotomy Fixation of Hallux Valgus Repair (Such as Scarf and Chevron Etc.)Medial Ankle Stabilization Tibiotalocalcaneal Arthrodesis

What is this study about?

Imagine you're having an operation on your foot or ankle. This study is all about making sure the special implants and devices used in these surgeries work well and are safe over a longer period. We're looking at different Arthrex products, which are like tiny, clever tools or parts that surgeons use to fix problems in your feet and ankles. These problems could be anything from bunions that need straightening, broken bones that need holding together, or even very flat feet that need support.

The main goal is to keep an eye on how these products perform after you've had your surgery. This means doctors will check your recovery, see how much your foot can move, and ask you about your pain and how easily you can do your everyday activities. Your feedback is really important in helping us understand if these products are making a positive difference in people's lives and ensuring they continue to be a good choice for future patients across the UK.

By carefully watching how patients get on, we can learn a lot. This helps us confirm that the products are doing their job, helping feet and ankles heal properly and comfortably. It's all about making surgical treatments as safe and effective as possible for everyone who needs them.

Key takeaways

This study evaluates how well different foot and ankle implants work after surgery.
It covers many conditions like bunions, fractures, and flat feet.
Participation involves follow-up visits and questionnaires about your recovery.
The goal is to ensure the products are safe and effective for future patients.
Your feedback is vital to improving foot and ankle care.
You can choose to leave the study at any time.

Who may be eligible?

To be able to join this study, you would generally need to be having surgery that uses one of the specific Arthrex foot and ankle products the study is looking at. Most participants need to be 18 years or older. However, if you're taking part specifically for a product called ProStop®, you could be as young as 2 years old, up to 17 years old.

You should also be able and willing to come back for follow-up appointments and complete some questionnaires, which help us understand how you're feeling. It's important that you (or your parent/guardian, if you're under 18) understand and agree to take part by signing a consent form.

There are also some reasons why you might not be able to join. For example, if you have very weak bones, poor blood flow that might stop you healing, an active infection, or allergies to foreign materials. You also can't take part if you're pregnant, a prisoner, or if your condition means you can't follow instructions during your recovery. If you're receiving compensation for a work-related injury, that would also stop you from joining.

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 having foot or ankle surgery using an Arthrex product?
Are you generally 18 or older (or 2-17 for ProStop®)?
Can you attend follow-up appointments and fill out questionnaires?
Do you understand and agree to take part in the study?
Do you have good bone quality and blood supply for healing?
Are you not pregnant, a prisoner, or have an active infection?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it means that after your surgery using one of the Arthrex foot and ankle products, we'll keep a close eye on your recovery. This will involve several follow-up appointments. Typically, you would have appointments at three months, six months, and one year after your operation. If you're using certain specific products, like ArthroFLEX® or the DualCompression Hindfoot Nail, you might also have an appointment at two years.

During these visits, a doctor will usually do a physical check-up of your foot or ankle to see how it's healing and moving. You'll also be asked to fill out questionnaires about how you feel, your pain levels, and how your foot or ankle affects your daily activities. For some specific products, we might also take X-rays or CT scans at certain times to see how the bones and implants are settling. There isn't any extra medication involved, just checks to see how you're getting on with the standard treatment.

Potential risks and benefits

Participating in this study means your doctors will be carefully monitoring your recovery, which could lead to a very thorough understanding of how you're healing. The main benefit is helping to improve knowledge about the safety and effectiveness of these products for future patients. There are no additional medical treatments in the study beyond your standard surgery with the Arthrex device. Potential risks are generally linked to any surgery, such as infection or issues with healing. The study itself involves time for follow-up appointments and filling out questionnaires. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (7)

UC Davis Medical Center
Verified postcode
Sacramento, United States· Recruiting
Northwestern University
Verified postcode
Chicago, United States· Recruiting
TOA Research Foundation
Verified postcode
Nashville, United States· Terminated
Barrett Podiatry
Verified postcode
San Antonio, United States· Terminated
Atlantic Orthopaedic Specialists
Verified postcode
Virginia Beach, United States· Recruiting
OrthoPedes
Verified postcode
Duisburg, Germany· Terminated
Dr Haroun Mahomed Orthopaedic Practice
Verified postcode
Durban, South Africa· Terminated

Common questions

What kind of foot and ankle problems are included in this study?

This study includes a wide range of conditions, such as bunions, fractured bones, very flat feet, and problems needing ankle stabilization or fusions.

Will I have to take any extra medication if I join this study?

No, there are no extra medications involved. You'll simply receive the standard surgical treatment with one of the Arthrex products.

How often will I need to visit the hospital if I take part?

You'll have follow-up visits at 3 months, 6 months, and 1 year after your surgery. Some patients may also have a 2-year visit.

What will I have to do at these follow-up visits?

Doctors will check your foot or ankle, you might have X-rays for some products, and you'll fill out questionnaires about your pain and daily activities.

Can I leave the study if I change my mind?

Yes, you can leave the study at any point without it affecting your medical care.

How to find out more

Justin Moss, DHSc

justin.moss@arthrex.com 770 584 4972 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.