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New knee system aims to help patients walk better for longer

NCT ID NCT01542580

Disease control Sponsor: Zimmer Biomet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how well a new knee replacement system works for people with severe knee pain from arthritis or previous failed surgeries. About 255 participants will receive the implant and be followed for up to 10 years. The goal is to see if the system improves knee alignment, function, and how long the implant lasts.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 255 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2012

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients prescribed the Vanguard 360 Revision Knee System

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. * Correction of varus, valgus or post-traumatic deformity * Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure * Ability and willingness of the patient to attend follow-up visit. * Willing to give written informed consent * Patients are at least 18 years of age, no upper age limit, must have reached full skeletal maturity. Exclusion Criteria: * infection * sepsis * osteomyelitis Relative Contraindications: * An uncooperative patient or a patient with neurologic disorders who is incapable of following directions * Osteoporosis * Metabolic disorders which may impair brain function * Osteomalacia * Distant foci of infections which may spread to the implant site * Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram * Vascular insufficiency, muscular atrophy, neuromuscular disease * Incomplete or deficient soft tissue surrounding the knee Additional research-related exclusion criteria: patients who have a history of or current infection in the affected knee.

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Conditions

The condition(s) this trial relates to.

osteoarthritis rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Complications; arthroplasty Deformity of limb Osteoarthritis Post traumatic deformity Rheumatoid arthritis Traumatic arthritis

Contacts and locations

Locations

  • Aarhus university hospital

    Aarhus, Denmark

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Italy

  • Ch Lyon Sud

    Lyon, 69000, France

  • IRCCS Istituto Ortopedico Galeazzi

    Milan, Italy

  • Illinois Bone and Joint

    Morton Grove, Illinois, 60053, United States

  • Klinik fur Endoprothetik und gelenkchirurgie

    Bad Wildbad, Germany

  • OrthoVirginia West End Orthopedic Clinic

    Richmond, Virginia, 23235, United States

  • Orthopedic Institute of Henderson

    Henderson, Nevada, 89052, United States

  • Royal Orthopaedic Hospital

    Birmingham, B31 2AP, United Kingdom

  • University Hopital Pellenberg

    Pellenberg, Belgium

  • University Hospital Mutua de Terrasa

    Terrassa, Spain

  • University of Utah Orthopedic Center

    Salt Lake City, Utah, 84108, United States

More trials for these conditions

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