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New knee implant aims to get patients moving again

NCT ID NCT05197036

Disease control Sponsor: Smith & Nephew, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This study follows 299 people who received the Smith+Nephew Porous Total Knee System, a titanium knee replacement for severe arthritis. The goal is to see if the implant reduces pain, improves movement, and lasts at least two years without needing revision surgery. Participants are either getting the implant now or have already received it in the past year.

What this could mean

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

Active substance
Total Knee Arthroplasty (surgical knee replacement with titanium prostheses)
What this could lead to
If successful, this could confirm that the Smith+Nephew Porous Total Knee System provides lasting pain relief and improved mobility for people with severe knee arthritis.
What could go wrong
This is an observational follow-up study, not a randomized controlled trial, so results may not prove superiority over other implants. Some patients may still experience complications like implant loosening or infection.

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

299 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Dec 2033

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

Patient population will be selected by investigators from their clinics. Patients who report pain/mobility issues and who have been recommended for total knee replacement with Porous Total Knee System by their surgeon.

Ages

18 to 80 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: 1. A) Subject needing primary TKA due to degenerative joint disease (primary diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory arthritis. OR B) Subject has undergone primary TKA with Smith+Nephew Porous knee system in past 12 months to repair degenerative joint disease, post- traumatic arthritis or inflammatory arthritis and all the following conditions have been met: * Preoperative KOOS JR and radiographs have been obtained * 6-Month KOOS JR and radiographs have been obtained or these can be collected prospectively in window per schedule of events 2. Subject agrees to consent and to follow the prospective study visit schedule (as defined in the study protocol and informed consent form) by signing the Independent Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form. 3. Subject is willing to attend study follow-up visits for up to five (5) years post-surgery. 4. Subject is able to read, understand, and communicate responses to Patient Reported Outcome assessments. 5. Subject is 18-80 years old (inclusive). Exclusion Criteria: 1. Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty. 2. Subject has a Body Mass Index (BMI) ≥ 40 at time of surgery. 3. Subject has ipsilateral hip arthritis resulting in flexion contracture. 4. At the time of enrolment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator: Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty; Contralateral primary total knee or unicondylar knee arthroplasty. 5. Subject has a condition that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, lupus, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease). 6. Subject has a known allergy to one or more of its components of the study device. 7. Any subject with hardware present in distal femur or proximal tibia. 8. Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55. 9. Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days. 10. Subject, in the opinion of the Investigator, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, drug or alcohol abuse. 11. Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits. 12. Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures. 13. Subjects who have participated previously in this clinical trial and who have been withdrawn.

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Conditions

The condition(s) this trial relates to.

arthritic joint disease osteoarthritis rheumatoid arthritis

As listed by the trial registrant

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

Osteoarthritis Post traumatic arthritis Rheumatoid arthritis

Contacts and locations

Locations

  • Columbia University

    New York, New York, 10032, United States

  • Concordia Joint Replacement Group

    Winnipeg, Manitoba, R2K2M9, Canada

  • Duke Health

    Morrisville, North Carolina, 27560, United States

  • Emory Orthopaedics and Spine Hospital

    Atlanta, Georgia, 30084, United States

  • Erlanger Health

    Chattanooga, Tennessee, 37403, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical Center Leeuwarden

    Leeuwarden, Leeuwarden, 8934, Netherlands

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • NYU Langone Health Orthopedic Hospital

    New York, New York, 10016, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Sint Maartenskliniek

    Ubbergen, Ubbergen,, 6574, Netherlands

  • St George and Sutherland Centre for Clinical Orthopaedic Research

    Sydney, New South Wales, Australia

  • Syracuse Orthopedic Specialists

    East Syracuse, New York, 13057, United States

  • The Avenue Hospital

    Windsor, Victoria, 3181, Australia

  • The Core Institute

    Novi, Michigan, 48374, United States

  • UTHealth

    Houston, Texas, 77401, United States

  • Umeå University Hospital

    Umeå, Umeå, 90737, Sweden

  • University of Wisconsin

    Madison, Wisconsin, 52718, United States

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