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Clinical Trials in Canada / NCT05197036
Active, not recruiting Observational

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

NCT05197036 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2021-12-21
Last updated
2026-08-11

Condition(s) studied

OsteoarthritisPost-traumatic ArthritisRheumatoid Arthritis

Investigational drug(s) / intervention(s)

Total Knee Arthroplasty

Total Knee Arthroplasty: A surgical procedure to replace both the tibial and femoral articular surfaces with titanium prostheses.

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
Emory Orthopaedics and Spine Hospital Atlanta Georgia
Massachusetts General Hospital Boston Massachusetts
The Core Institute Novi Michigan
Syracuse Orthopedic Specialists East Syracuse New York
NYU Langone Health Orthopedic Hospital New York New York
Columbia University New York New York
Duke Health Morrisville North Carolina
Oregon Health & Science University Portland Oregon
Medical University of South Carolina Charleston South Carolina
Erlanger Health Chattanooga Tennessee
UTHealth Houston Texas
University of Wisconsin Madison Wisconsin
St George and Sutherland Centre for Clinical Orthopaedic Research Sydney New South Wales
The Avenue Hospital Windsor Victoria
Concordia Joint Replacement Group Winnipeg Manitoba
Medical Center Leeuwarden Leeuwarden Leeuwarden
Sint Maartenskliniek Ubbergen Ubbergen,
Umeå University Hospital Umeå Umeå

More Smith & Nephew, Inc. trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05197036 on ClinicalTrials.gov ↗ ← All trials in Canada