RecruitingNAINTERVENTIONAL

G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study

This study is investigating two specific types of hip replacement parts, called Vivacit-E and Longevity liners, which are used with the G7 Acetabular System. The main goal is to see how safe and effective these liners are over a long period, specifically 10 years, for people who have had a total hip replacement. This includes patients with common conditions like osteoarthritis, rheumatoid arthritis, or those who have suffered a hip fracture. Researchers will be monitoring the implants to ensure they remain in place and work well, while also checking for any potential problems or side effects. They'll also ask patients about their experience to understand the overall benefits.

At a glance

Status

Recruiting

Phase

Sponsor

Zimmer Biomet

Enrolment target

300

Start

07 Jul 2021

Estimated completion

31 Dec 2033

Total Hip Arthroplasty Degenerative Joint Disease of Hip Avascular Necrosis of Hip Rheumatoid Arthritis of Hip Osteoarthritis, Hip Osteoarthritis of Hip Fractures, Hip Fracture of Hip

What is this study about?

This research study is focusing on specific parts used in total hip replacement surgery. When you have a hip replacement, a new "ball and socket" joint is put into your hip. This study is looking at the 'socket' part, specifically two types of liners called Vivacit-E and Longevity. These liners are used with a system known as the G7 Acetabular Shell. The main reason for this study is to confirm that these liners are safe and work well over a long time, helping people who need a hip replacement due to conditions like arthritis or hip fractures.

Researchers want to understand how these particular hip replacement parts perform for up to 10 years after surgery. They will be checking if the implants stay securely in place and continue to function as expected. They'll also be carefully monitoring for any unexpected problems or side effects that might occur. This helps ensure these hip replacement options are reliable and beneficial for patients.

An important part of this study involves collecting information directly from patients about their hip function and quality of life after surgery. This is combined with medical observations to get a complete picture of how effective these liners are in helping people regain movement and reduce pain. The information gathered will help doctors and patients make informed decisions about hip replacement options in the future.

Key takeaways

Studies the long-term safety and performance of specific hip replacement parts.
Focuses on Vivacit-E and Longevity liners for total hip replacements.
Aims to understand how these parts work for up to 10 years.
Includes patients with common hip problems like arthritis and fractures.
Involves regular follow-up assessments and patient feedback.
Participation is voluntary and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you must be an adult who has finished growing. You would typically be someone needing a hip replacement for conditions like osteoarthritis, rheumatoid arthritis, or to fix a hip fracture. It also includes cases where a previous hip treatment or device hasn't worked.

Most importantly, you need to be able and willing to attend all required follow-up appointments and give your informed consent to take part in the study. This means you understand what the study involves and agree to participate voluntarily.

However, certain health conditions might mean you can't join. For example, if you have severe bone weakening (like some forms of osteoporosis or osteomalacia), certain metabolic disorders, active infections, or significant bone loss in your hip. Also, if you are pregnant, a prisoner, or unable to follow instructions due to other conditions, you would not be eligible.

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 an adult who has finished growing?
Do you need a hip replacement for conditions like severe arthritis or a hip fracture?
Are you able and willing to attend follow-up appointments for up to 10 years?
Do you *not* have severe bone weakening (like osteoporosis) or an active infection?
Are you *not* currently pregnant or a prisoner?

Answer every question to see your result.

What does participation involve?

If you join this study, your experience would be similar to having a standard total hip replacement, as the study focuses on specific liner components rather than a new surgical approach. After your surgery, you would have regular follow-up visits over a period of up to 10 years. During these visits, doctors would assess your hip, ask you about your pain and how well you can move, and possibly take X-rays if needed. They would also monitor for any side effects or complications. There are no special medications involved specifically for the study. The total duration of your participation would be for these long-term follow-up assessments.

Potential risks and benefits

Taking part in this study means you would receive a standard hip replacement, which carries the typical risks associated with any major surgery, such as infection, blood clots, or issues with the implant. The information gathered may help improve hip replacement options for future patients. However, there's no guarantee of direct personal benefit beyond what you would expect from a standard hip replacement. You are free to withdraw from the study at any time without affecting your medical care.

Locations (11)

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

Colorado Joint Replacement
Verified postcode
Denver, United States· Active not recruiting
South Bend Orthopaedics
Verified postcode
South Bend, United States· Active not recruiting
Duke University Medical Center
Verified postcode
Durham, United States· Active not recruiting
Slocum Center for Orthopedics & Sports Medicine
Verified postcode
Eugene, United States· Active not recruiting
Oregon Health and Science University
Verified postcode
Portland, United States· Active not recruiting
University of Utah Health
Verified postcode
Salt Lake City, United States· Active not recruiting
Copenhagen University Hospital Hvidovre
Verified postcode
Hvidovre, Denmark· Recruiting
Zuyderland Hospital
Verified postcode
Geleen, Netherlands· Active not recruiting
OCON Hengelo
Verified postcode
Hengelo, Netherlands· Recruiting
Skane University Hospital
Verified postcode
Lund, Sweden· Recruiting
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth Hospital
Verified postcode
Bournemouth, United Kingdom· Recruiting

Common questions

What parts of the hip replacement are being studied?

This study is looking at two types of liners, Vivacit-E and Longevity, which are parts of the 'socket' used in total hip replacement surgery.

How long will the study last for me?

You would be followed for up to 10 years after your hip replacement surgery to check on the long-term performance of the implant.

Do I need to take any special medication?

No, there are no special medications you would need to take as part of this study.

What conditions qualify a person for this study?

You might qualify if you need a hip replacement due to severe arthritis (like osteoarthritis or rheumatoid arthritis), a hip fracture, or if previous hip treatments have failed.

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

Yes, you have the right to withdraw from the study at any time, and this will not affect the medical care you receive.

How to find out more

Wendy J Hatcher

wendy.hatcher@zimmerbiomet.com 574-549-4281 Official trial record

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