Active not recruitingOBSERVATIONAL

Registry of Avance® Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction

This study is like a large collection of information, called a registry, focusing on how a special nerve graft called Avance is used for repairing damaged nerves. Researchers want to understand where and how often it's used, how well patients recover, and if there are any side effects in everyday medical practice. The study also includes optional parts to compare Avance with standard treatments, like using your own nerve tissue or a nerve tube. Another part specifically looks at breast reconstruction surgery after a mastectomy, comparing those who have their nerves reconnected (neurotization) with those who don't, to see if adding nerve connections improves feeling.

At a glance

Status

Active not recruiting

Sponsor

Axogen Corporation

Enrolment target

3,126

Start

01 Nov 2008

Estimated completion

01 Nov 2028

Peripheral Nerve Injuries

What is this study about?

Imagine you've had an injury that affects a nerve, perhaps in your arm or leg, making it difficult to feel or move properly. This study is collecting information about different ways doctors repair these damaged nerves. One specific repair method they are interested in uses something called an Avance Nerve Graft. This graft is made from processed human nerve tissue and helps guide the ends of your injured nerve back together so it can heal.

The main goal of this study is to see how well the Avance Nerve Graft works in real-world situations. Doctors will be looking at existing medical records to understand how it's being used, how patients are recovering, and if there are any problems or side effects. This helps them learn more about the treatment's safety and effectiveness for different types of nerve injuries.

There are also two optional parts to the study. One part compares the Avance Nerve Graft with other common nerve repair techniques, such as using a piece of nerve taken from your own body (called an autograft) or using a special tube to help nerves heal. The other part focuses on breast reconstruction surgery after cancer removal. It specifically looks at whether reconnecting nerves during this surgery can help improve sensation in the new breast tissue.

Key takeaways

This study collects information on nerve repair surgeries that have already happened.
It aims to understand how well the Avance Nerve Graft works in real-life situations.
It compares different nerve repair methods, including using your own nerve or a nerve tube.
A special part of the study looks at sensation after breast reconstruction with and without nerve reconnection.
It helps doctors improve future treatments for nerve injuries.
Your participation primarily involves data from your medical records, with minimal direct involvement.

Who may be eligible?

Generally, you might be included in the main part of this study if you've had a nerve injury repaired using the Avance Nerve Graft and have attended at least one follow-up appointment afterward. The doctors involved will decide if you're a good fit, especially making sure you'll likely complete your recovery check-ups.

If you have an upper arm or hand nerve injury, and it was repaired using your own nerve (an autograft) or a special nerve tube after 2004, you might be considered for an additional part of the study. This part is looking at these other types of repairs in more detail, as long as your nerve gap wasn't too large (less than about 7cm).

There's also a specific part of the study for women over 18 who have had breast reconstruction after a mastectomy using their own tissue, where nerves were reconnected between the new breast and the chest. If nerves weren't reconnected, you might also be part of a comparison group to see the difference in feeling. For this part, you'd need to have specific sensation tests and answer questionnaires a few months after your surgery.

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.

Have you had a nerve repair using an Avance Nerve Graft?
Have you attended at least one follow-up appointment after your nerve repair?
If interested in comparisons, did you have an upper extremity (arm/hand) nerve injury repaired with your own nerve or a nerve tube after 2004?
Are you a woman over 18 who has had breast reconstruction with your own tissue after a mastectomy?
If so, was your breast reconstruction done with nerves reconnected, or without?

Answer every question to see your result.

What does participation involve?

This study is primarily collecting information from your existing medical records regarding your nerve repair and recovery. You wouldn't be asked to try a new treatment or medication specifically for this study. If your doctor feels you are suitable for one of the additional parts of the study, it might involve making sure certain follow-up tests, like sensation assessments or questionnaires about your well-being, are completed at specific times after your surgery. However, these are generally part of your usual post-operative care.

Potential risks and benefits

This study is mainly about collecting information from medical records, so there are no new medical treatments or procedures involved, meaning no additional risks to your health. The potential benefit is that the information gathered will help doctors better understand different nerve repair methods, including the Avance Nerve Graft, and how they affect patient recovery. This knowledge could lead to improved treatments for future patients with nerve injuries. You always have the right to decide not to have your medical information included in the study, and this decision will not affect your care.

Locations (49)

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

RANGER & MATCH: Arizona Center for Hand Surgery
Verified postcode
Phoenix, United States
RANGER: Phoenix Children's Hospital
Verified postcode
Phoenix, United States
RANGER & MATCH: University of California - Irvine
Verified postcode
Orange, United States
RANGER & MATCH: The Buncke Clinic
Verified postcode
San Francisco, United States
Sensation-NOW: Stanford University
Verified postcode
Stanford, United States
Sensation-NOW: University of Colorado School of Medicine
Verified postcode
Aurora, United States
Sensation-NOW: George Washington University
Verified postcode
Washington D.C., United States
RANGER: University of Miami
Verified postcode
Miami, United States
RANGER & MATCH: Florida Orthopaedic Institute
Verified postcode
Tampa, United States
RANGER: Hand & Upper Extremity Center of Georgia/Children's Hospital of Atlanta
Verified postcode
Atlanta, United States
RANGER & MATCH: University of Kansas Medical Center
Verified postcode
Kansas City, United States
Sensation-NOW: University of Kansas Medical Center
Verified postcode
Kansas City, United States

Common questions

What is an Avance Nerve Graft?

It's a special graft made from processed human nerve tissue, used by doctors to help repair damaged nerves by bridging the gap and guiding the nerve ends to heal.

Will I have to take any new medicines?

No, this study doesn't involve taking any new medications. It's about looking at existing medical information on treatments you've already received.

How long will I be in the study?

Because this study primarily reviews existing medical records, your active involvement is minimal. The researchers will be collecting information over a period of time, but you won't have to keep attending extra appointments for the study itself.

What does 'neurotization' mean?

Neurotization is when nerves are reconnected during surgery. In breast reconstruction, it means connecting nerves in the new breast tissue to nerves in the chest wall, aiming to improve feeling.

Will my personal details be kept private?

Yes, all information collected for the study is handled with strict confidentiality to protect your privacy. Your identity will not be shared.