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
A Multi-Centre Study in Patients Undergoing Total Knee Replacement With Smith+Nephew Porous Total Knee Arthroplasty (TKA) System
1 other identifier
observational
299
5 countries
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 21, 2021
CompletedFirst Submitted
Initial submission to the registry
January 4, 2022
CompletedFirst Posted
Study publicly available on registry
January 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 25, 2033
January 30, 2026
January 1, 2026
4.5 years
January 4, 2022
January 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Implant Survivorship (femoral and/or tibial component) 2 Years Post-Surgery
Survivorship of the femoral and/or tibial component of the implant is defined as the cumulative proportion of femoral and/or tibial components without a revision.
2 years post-surgery
Secondary Outcomes (9)
Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR)
Pre-op, 6 weeks, 6 months, 2 years, 3 years, 5 years and 10 years
Patient Reported Outcomes - Oxford Knee Score (OKS)
Pre-op, 6 weeks, 6 months, 2 years, 3 years, 5 years and 10 years
Patient Reported Outcomes - Forgotten Joint Score (FJS)
Pre-op, 6 weeks, 6 months, 2 years, 3 years, 5 years and 10 years
Radiographic Assessment - Implant Position
6 months, 2 years, 5 years and 10 years
Radiographic Assessment - Implant Migration
6 months, 2 years, 5 years and 10 years
- +4 more secondary outcomes
Study Arms (2)
LEGION Porous CR with Hydroxyapatite
Patients who have already received or a due to receive a Porous Tibia + LEGION Porous CR with HA femoral component (min 117 subjects)
LEGION Porous CR without Hydroxyapatite
Patients who have already received or a due to receive a Porous Tibia + LEGION Porous CR without HA femoral component (min 117 subjects)
Interventions
A surgical procedure to replace both the tibial and femoral articular surfaces with titanium prostheses.
Eligibility Criteria
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.
You may qualify if:
- A) Subject needing primary TKA due to degenerative joint disease (primary diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory arthritis.
- 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
- Month KOOS JR and radiographs have been obtained or these can be collected prospectively in window per schedule of events
- 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.
- Subject is willing to attend study follow-up visits for up to five (5) years post-surgery.
- Subject is able to read, understand, and communicate responses to Patient Reported Outcome assessments.
- Subject is 18-80 years old (inclusive).
You may not qualify if:
- Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty.
- Subject has a Body Mass Index (BMI) ≥ 40 at time of surgery.
- Subject has ipsilateral hip arthritis resulting in flexion contracture.
- 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.
- 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).
- Subject has a known allergy to one or more of its components of the study device.
- Any subject with hardware present in distal femur or proximal tibia.
- Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.
- Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days.
- 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.
- Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
- Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures.
- Subjects who have participated previously in this clinical trial and who have been withdrawn.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Emory Orthopaedics and Spine Hospital
Atlanta, Georgia, 30084, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
The Core Institute
Novi, Michigan, 48374, United States
Syracuse Orthopedic Specialists
East Syracuse, New York, 13057, United States
NYU Langone Health Orthopedic Hospital
New York, New York, 10016, United States
Columbia University
New York, New York, 10032, United States
Duke Health
Morrisville, North Carolina, 27560, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Erlanger Health
Chattanooga, Tennessee, 37403, United States
UTHealth
Houston, Texas, 77401, United States
University of Wisconsin
Madison, Wisconsin, 52718, United States
St George and Sutherland Centre for Clinical Orthopaedic Research
Sydney, New South Wales, Australia
The Avenue Hospital
Windsor, Victoria, 3181, Australia
Concordia Joint Replacement Group
Winnipeg, Manitoba, R2K2M9, Canada
Medical Center Leeuwarden
Leeuwarden, Leeuwarden, 8934, Netherlands
Sint Maartenskliniek
Ubbergen, Ubbergen,, 6574, Netherlands
Umeå University Hospital
Umeå, Umeå, 90737, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Amir Kamali
Smith & Nephew, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2022
First Posted
January 19, 2022
Study Start
December 21, 2021
Primary Completion (Estimated)
June 19, 2026
Study Completion (Estimated)
December 25, 2033
Last Updated
January 30, 2026
Record last verified: 2026-01