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Knee replacement showdown: which implant works best?

NCT ID NCT03073941

Symptom relief 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares two knee replacement systems, Persona and NexGen, in 332 people with knee osteoarthritis. Participants receive one of the two implants during surgery. Researchers track pain, function, and quality of life for up to two years to see if one system leads to better outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Persona total knee system (device) and NexGen total knee system (device)
What this could lead to
If one system proves better, it could lead to improved knee function and less pain after replacement surgery.
What could go wrong
This is a device comparison study, not a new treatment. Results may show no meaningful difference, and individual outcomes vary.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

332 people

The number who actually took part.

Started

Dec 2016

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.

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: * Clinical and radiological osteoarthritis of the knee set to receive a primary unilateral total knee replacement * \>18 years of age * Participants must be able to speak and understand Danish * Participants must be able to give informed consent and be cognitively intact * Participants must be able to complete all post-operative controls * Participants must not have severe comorbidities, American Society of Anesthesiologists (ASA) score ≤ 3 * Clinically suitable to receive a CR implant (no severe deformity and/or ligament instability) Exclusion Criteria: * Terminal illness * Revision knee replacement surgery * Rheumatoid Arthritis (RA) * Traumatic etiology * Prior surgery on the affected knee that includes osteosynthesis, Anterior cruciate ligament (ACL) and/or Posterior cruciate ligament (PCL) and/or collateral ligament surgery. Arthroscopy with meniscectomy / cartilage surgery / house cleaning is allowed. * Altered pain perception and / or neurologic affection due to diabetes or other disorders. * Patients will be excluded intraoperative if CR implant is not suitable.

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Conditions

The condition(s) this trial relates to.

osteoarthritis, knee

As listed by the trial registrant

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

Osteoarthritis, knee

Contacts and locations

Locations

  • Copenhagen University hospital, Gentofte

    Copenhagen, DK-2900, Denmark

  • Dept. of Orthopaedic Surgery, Farsø Sygehus, Ålborg Universitetshospital

    Aalborg, DK-9000, Denmark

  • Dept. of Orthopaedic Surgery, Næstved Sygehus

    Næstved, DK-4700, Denmark

  • Dept. of Orthopaedic Surgery, Vejle Sygehus, Sygehus Lillebælt

    Vejle, DK-7100,, Denmark

  • Hvidovre hospital

    Copenhagen, Denmark

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