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Can a new knee implant design offer better Long-Term relief?

NCT ID NCT06670651

Disease control Sponsor: LinkBio Corp. 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This study tests a new total knee replacement system called LinkSymphoKnee, which uses an ultra-congruent bearing surface designed to provide stability and mimic natural knee movement. Researchers will enroll 600 adults aged 18 to 79 who need a knee replacement due to osteoarthritis, a fracture, or rheumatoid arthritis. Participants will receive the device during standard surgery, and the study will track their knee function, pain, and whether any require additional surgery over time. The goal is to see if this implant performs well and improves patients' quality of life.

What this could mean

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

Active substance
A total knee replacement device with an ultra-congruent tibial bearing surface, called the LinkSymphoKnee system
What this could lead to
If it works, this could lead to a more durable and comfortable knee replacement option for people with severe knee damage, potentially reducing the need for repeat surgery.
What could go wrong
This is a large study, but results depend on long-term follow-up. Some patients may still experience complications like implant loosening or infection, and the device may not outperform existing knee replacements.

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 600 people

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

Started

Mar 2025

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 seeking primary total knee arthroplasty from the participating surgeon investigators

Ages

18 to 79 years

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: * 18 years or older, and skeletally mature; and * Undergoing a primary TKA for one or both knees using the cemented LinkSymphoKnee knee system as part of the surgeon's standard of care. * Able to read and understand English (because patient-reported outcome questionnaires are not validated for all potential other languages). Exclusion Criteria: * 80 years of age or older, * Women who are pregnant at the time of surgery, * History of joint sepsis, * Bone defect that requires grafting, * Previous history of bone disease (e.g., severe osteoporosis or osteomalacia) which in the surgeon's opinion is severe enough to compromise device fixation, * Systemic conditions affecting bone density (e.g., inflammatory arthritis or renal disease) which in the surgeon's opinion are severe enough to compromise device fixation, * A poorly functioning contralateral total knee replacement or a contralateral revision regardless of function.

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Conditions

The condition(s) this trial relates to.

bone fracture osteoarthritis osteoarthritis, knee rheumatoid arthritis

As listed by the trial registrant

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

Fracture Osteoarthritis (OA) of the knee Rheumatoid arthritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Illinois Bone and Joint Institute

    Libertyville, Illinois, 60048, United States

  • OrthoAlabama Spine & Sports

    Birmingham, Alabama, 35235, United States

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