Active not recruitingNAINTERVENTIONAL

Persona Partial Knee Clinical Outcomes Study

This study is investigating a new type of partial knee replacement called the Persona Partial Knee System. It's designed for people experiencing knee pain due to conditions like osteoarthritis, bone damage (avascular necrosis), or certain knee injuries. The main aim is to understand how effective this knee replacement is in reducing pain and improving movement, and how long it lasts in patients. Researchers will gather information from many hospitals and clinics, following patients for at least two years, with the option to continue for up to ten years. This will help doctors and patients understand the long-term benefits and any potential issues with this specific knee replacement.

At a glance

Status

Active not recruiting

Phase

Sponsor

Zimmer Biomet

Enrolment target

757

Start

08 Feb 2017

Estimated completion

01 Sep 2030

Osteoarthritis Avascular Necrosis Traumatic Arthritis Conditional Tibial Condyle or Plateau Fractures Conditional Revision of the Articular Surface

What is this study about?

Imagine you have persistent knee pain that makes everyday activities difficult, perhaps from arthritis or an old injury. Sometimes a doctor might suggest a partial knee replacement. This study is all about a specific type of partial knee replacement called the Persona Partial Knee System.

The main goal of this research is to see how well this particular knee replacement works in real-world patients. The doctors and researchers want to understand if it truly helps reduce pain, improve how your knee moves, and enhance your overall quality of life. They're also very interested in how long the knee replacement lasts without needing further surgery.

By carefully following many patients who receive this partial knee replacement, the study will gather important information over several years. This information will help doctors understand who might benefit most from this specific treatment and what to expect in the long term, ensuring patients receive the best possible care for their knee problems.

Key takeaways

This study is observing a specific partial knee replacement called the Persona Partial Knee.
It aims to understand how well the implant works, reduces pain, and how long it lasts.
Patients are followed through regular check-ups for at least 2 years, possibly up to 10 years.
The study includes people with knee pain from arthritis, bone damage, or certain injuries.
Participation involves signing a consent form and attending scheduled follow-up visits.

Who may be eligible?

To join this study, you need to be at least 18 years old and your doctor must agree that a Persona Partial Knee replacement is suitable for your knee problem. You must also be willing to understand and sign a consent form, and commit to attending all the scheduled check-ups for the study.

However, there are reasons you might not be able to take part. For example, if you have an infection in your knee, certain types of arthritis like rheumatoid arthritis, or if the ligaments in your knee are too damaged. Also, if you're taking part in other surgical or pain studies, or if your bones aren't strong enough, you wouldn't be able to join. Your doctor will carefully check all these points with you.

Quick self-check

Are you at least 18 years old?
Has your doctor said a partial knee replacement is right for you?
Are you able and willing to attend regular check-ups for several years?
Do you *not* have an active infection in your knee?
Do you *not* have rheumatoid arthritis or similar widespread joint conditions?
Are you *not* currently pregnant or participating in another surgical study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, the first step is to learn all about it and sign a consent form. Before your partial knee replacement surgery, you’ll have a full medical check-up. After your operation, you'll need to attend follow-up visits with the study team. These check-ups will usually be at 3 months, 1 year, and 2 years after your surgery. There's also a chance to continue monitoring your progress for up to 10 years, with visits at 5 and 10 years.

During these visits, the doctors will likely ask you questions about your pain and how well your knee is working, and they will probably take X-rays of your knee. They will also keep an eye on any side effects or problems you might experience. You won't be given any new medications specifically for the study; it's about checking how your Persona Partial Knee works over time.

Potential risks and benefits

Participating in this study might offer you the benefit of close monitoring of your recovery and the performance of your new knee joint. The main potential risks are those associated with knee replacement surgery itself, such as infection, blood clots, or issues with the implant, which your surgeon will discuss with you. You are free to withdraw from the study at any time, for any reason, without it affecting the standard medical care you receive.

Locations (24)

Sah Orthopaedic Associates
Fremont, United States
Panorama Orthopedics & Spine Center
Golden, United States
Midwest Orthopaedics at Rush
Chicago, United States
Henry County Orthopedics and Sports Medicine
New Castle, United States
Sports Medicine North
Beverly, United States
Troy Orthopaedic Associates
Troy, United States
New Mexico Orthopaedics
Albuquerque, United States
Midlands Orthopaedics & Neurosurgery
Columbia, United States
Skagit Regional Clinics-Riverbend
Mount Vernon, United States
Orthopädisches Spital Speising
Vienna, Austria
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Marseille University-Hospital Centres
Marseille, France

+12 more sites — see the official record for the full list.

Common questions

What is a 'partial knee replacement'?

It's a surgery where only the damaged part of your knee is replaced with an artificial implant, rather than the whole knee joint. It's often used when the damage is limited to one area of the knee.

What kind of knee problems is this study looking at?

The study focuses on people with knee pain from conditions like osteoarthritis (wear and tear arthritis), damage to the bone (avascular necrosis), or certain types of knee fractures.

How long will I be followed in this study?

You will be followed for at least two years after your surgery, with check-ups at 3 months, 1 and 2 years. There's also the option for longer follow-up, up to 10 years, with visits at 5 and 10 years.

Do I have to take new medicines for this study?

No, this study is about checking how the Persona Partial Knee implant works. You won't be asked to take any new or special medicines just for the study itself.

Can I leave the study if I change my mind?

Yes, you are free to stop participating in the study at any time, for any reason, and it won't affect the care you receive from your doctors.