RecruitingNAINTERVENTIONAL

The Ailliance Post-Market Clinical Study

The Ailliance study is collecting important information about Medtronic devices used for conditions such as spinal deformity, back pain, or spinal injuries. It's called a 'post-market' study because it gathers data on devices already approved and in use, to ensure they continue to be safe and effective in real-world clinic settings. Participants are adults who are having one of these devices fitted. They will be followed up for up to two years after their operation. This helps doctors understand how the devices perform over time and ultimately aims to improve future care for people with similar conditions.

At a glance

Status

Recruiting

Phase

Sponsor

Medtronic Spinal and Biologics

Enrolment target

1,000

Start

01 May 2023

Estimated completion

01 May 2031

Spinal Deformity Spinal Degenerative Disorder Spinal Fusion Failure Spinal Trauma Spinal Tumor Case

What is this study about?

This study, called The Ailliance Post-Market Clinical Study, is designed to keep a close eye on Medtronic devices once they are being used by patients in their everyday treatment. These devices are used for a variety of conditions affecting the spine and sometimes the head, such as spinal deformities, ongoing back problems, or injuries to the spine. The main goal is to collect information about how well these devices work and how safe they are over time.

Think of it as a quality control check after a product has been released. Hospitals and clinics regularly use these devices, and this study helps gather consistent information about their performance and any potential side effects. By doing this, researchers can build a better picture of the real-world experience for patients.

Ultimately, the information gathered from this study is really important. It helps healthcare professionals understand the long-term effects and effectiveness of these devices, which can lead to improvements in patient care and confidence in the treatments available for spinal conditions.

Key takeaways

It's a study looking at Medtronic devices used for spinal or head conditions.
It collects information on how well these devices work and how safe they are in everyday medical practice.
Participation involves attending your usual follow-up appointments for up to two years after surgery.
There are no extra treatments or risks for study participants beyond standard care.
Your contribution helps improve our understanding and future care for patients with similar conditions.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old, and planning to have a Medtronic device fitted for a spinal or head-related condition as part of your normal treatment. You'll also need to be able to give your clear agreement to take part and attend all the planned check-up appointments.

There are a few reasons why you might not be able to join. For example, if you're already taking part in another study that involves new medicines or devices, or if there's a reason doctors think it might be difficult to keep in touch with you for your follow-up appointments. Also, if local laws or your personal circumstances mean you're considered 'vulnerable' when explaining the consent, you wouldn't be able to participate.

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 old or older?
Are you planning to have a Medtronic device fitted for a spinal or head-related issue?
Are you able to attend follow-up appointments for up to two years?
Are you not currently involved in another study that tests new drugs or devices?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it largely fits in with your usual medical care. Before your operation, there will be an initial assessment. After your procedure, you'll have check-up appointments for up to 24 months (two years). These appointments will gather information about how you're doing and how the device is performing. You won't be given any special medication or extra procedures just for the study; it focuses on observing your recovery and device performance as part of your standard treatment.

Potential risks and benefits

Taking part in this study won't change your medical treatment or the type of device you receive, as it observes standard care. There are no direct personal benefits from participating, but your contribution will help doctors and researchers understand how these devices work in the real world, potentially improving care for future patients. There are no extra physical risks beyond those associated with your planned surgery and recovery. You are always free to withdraw from the study at any time without it affecting your medical care.

Locations (27)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Arizona
Verified postcode
Tucson, United States· Recruiting
OrthoArkansas
Verified postcode
Little Rock, United States· Recruiting
University of California Davis Medical Center
Verified postcode
Sacramento, United States· Recruiting
University of California, San Francisco (UCSF)
Verified postcode
San Francisco, United States· Recruiting
Indiana University School of Medicine
Verified postcode
Bloomington, United States· Recruiting
Indiana Spine Group
Verified postcode
Carmel, United States· Recruiting
The Orthopaedic Research Foundation (OrthoIndy)
Verified postcode
Indianapolis, United States· Recruiting
Norton Leatherman Spine Specialists
Verified postcode
Louisville, United States· Recruiting
University of Maryland Medical Center
Verified postcode
Baltimore, United States· Recruiting
Michigan Orthopaedic & Spine Surgeons
Verified postcode
Rochester Hills, United States· Recruiting
University of Minnesota
Verified postcode
Minneapolis, United States· Recruiting
Washington University School of Medicine
Verified postcode
St Louis, United States· Recruiting

Common questions

What kind of devices are being studied?

Medtronic devices used for spinal and sometimes cranial (head) conditions, which are already approved for use, are being looked at.

Do I get any special treatment if I join?

No, your treatment remains exactly the same as it would be if you weren't in the study. The study simply collects information about your standard care.

How long will I need to be involved?

You'll be followed up from before your operation until up to two years afterwards, attending regular check-ups during this period.

Will taking part affect my medical care?

No, joining or leaving the study will not affect the medical care you receive for your condition at all.

What happens to my information?

Your information will be collected to assess how the devices perform and how safe they are, contributing to general knowledge in a way that respects your privacy.

How to find out more

Lauren Oien

lauren.k.oien@medtronic.com +17635268124 Official trial record

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