A Global Clinical Study Investigating the Safety and Effectiveness of Smith and Nephew's Porous Knee System in Patients Who Need a Total Knee Replacement Due to Degenerative Arthritis, Post-traumatic Arthritis or Inflammatory Arthritis

Last updated: August 2, 2024
Sponsor: Smith & Nephew, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Rheumatoid Arthritis

Dermatomyositis (Connective Tissue Disease)

Musculoskeletal Diseases

Treatment

Total Knee Arthroplasty

Clinical Study ID

NCT05197036
POROUS.TKA.SYSTEM.2021.07
  • Ages 18-80
  • All Genders

Study Summary

A clinical trial investigating the safety and effectiveness of Smith and Nephew's FDA-approved Porous Total Knee System, which is used to replace worn away and diseased knee joints. The aim of this study is to show that most patients who receive the Porous Total Knee System have reduced pain, greater mobility and a long-lasting implant post-surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. A) Subject needing primary TKA due to degenerative joint disease (primary diagnosisof osteoarthritis), post-traumatic arthritis or inflammatory arthritis. OR B) Subject has undergone primary TKA with Smith+Nephew Porous knee system in past 12months to repair degenerative joint disease, post- traumatic arthritis orinflammatory 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 collectedprospectively in window per schedule of events

  1. Subject agrees to consent and to follow the prospective study visit schedule (asdefined in the study protocol and informed consent form) by signing the IndependentReview Board (IRB)/Independent Ethics Committee (IEC) approved informed consentform.

  2. Subject is willing to attend study follow-up visits for up to five (5) yearspost-surgery.

  3. Subject is able to read, understand, and communicate responses to Patient ReportedOutcome assessments.

  4. Subject is 18-80 years old (inclusive).

Exclusion

Exclusion Criteria:

  1. Subject received TKA on the contralateral knee as a revision for a previously failedtotal 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 arthroplastiesthat are not fully healed and well-functioning, as determined by the investigator:Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacingarthroplasty; 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 neuromusculardisease).

  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 treatedwith an investigational product in the past 30 days.

  10. Subject, in the opinion of the Investigator, has an emotional or neurologicalcondition that would pre-empt their ability or willingness to participate in thestudy including mental illness, drug or alcohol abuse.

  11. Subject is known to be at risk for lost to follow-up, or failure to return forscheduled visits.

  12. Women who are pregnant, nursing, or of child-bearing potential who are not utilizinghighly effective birth control measures.

  13. Subjects who have participated previously in this clinical trial and who have beenwithdrawn.

Study Design

Total Participants: 299
Treatment Group(s): 1
Primary Treatment: Total Knee Arthroplasty
Phase:
Study Start date:
December 21, 2021
Estimated Completion Date:
December 25, 2028

Study Description

Patients who need a total knee replacement or have recently had a total knee replacement with the Smith and Nephew Porous Total Knee System will be enrolled into the study. Before surgery X-rays will be collected and questionnaires will be administered which ask the patient about knee pain, activities of daily living, quality of life and how they feel about their knee. The same X-rays and questionnaires will be asked before surgery and then after surgery at various intervals up to 5 years post-surgery.

Connect with a study center

  • St George and Sutherland Centre for Clinical Orthopaedic Research

    Sydney, New South Wales
    Australia

    Site Not Available

  • OrthoSport Victoria

    Melbourne, Victoria 3121
    Australia

    Site Not Available

  • Robina Hospital

    Robina, Victoria 3121
    Australia

    Site Not Available

  • The Avenue Hospital

    Windsor, Victoria 3181
    Australia

    Site Not Available

  • Concordia Joint Replacement Group

    Winnipeg, Manitoba R2K2M9
    Canada

    Site Not Available

  • Sint Maartenskliniek

    Ubbergen, Ubbergen, 6574
    Netherlands

    Site Not Available

  • Medical Center Leeuwarden

    Leeuwarden, 8934
    Netherlands

    Site Not Available

  • Umeå University Hospital

    Umeå, 90737
    Sweden

    Site Not Available

  • Orthopaedic Specialists of Connecticut

    Brookfield, Connecticut 06804
    United States

    Site Not Available

  • Emory Orthopaedics and Spine Hospital

    Atlanta, Georgia 30084
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40506
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • The Core Institute

    Novi, Michigan 48374
    United States

    Site Not Available

  • Syracuse Orthopedic Specialists

    East Syracuse, New York 13057
    United States

    Site Not Available

  • Columbia University

    New York, New York 10032
    United States

    Site Not Available

  • NYU Langone Health Orthopedic Hospital

    New York, New York 10016
    United States

    Site Not Available

  • Duke Health

    Morrisville, North Carolina 27560
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Erlanger Health

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • UTHealth

    Houston, Texas 77401
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 52718
    United States

    Site Not Available

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