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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 10 years post-surgery.

Official Title
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A Multi-Centre Study in Patients Undergoing Total Knee Replacement With Smith+Nephew Porous Total Knee Arthroplasty (TKA) System

Conditions
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Osteoarthritis, Post-traumatic Arthritis, Rheumatoid Arthritis

Intervention / Treatment
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* Procedure: Total Knee Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 12-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 ten (10) years post-surgery. Subject is able to read, understand, and communicate responses to Patient Reported Outcome assessments. Subject is 18-80 years old (inclusive). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LEGION Porous CR with Hydroxyapatite<br>Patients who have already received or a due to receive a Porous Tibia + LEGION Porous CR with HA femoral component (max 175 subjects) | Procedure: Total Knee Arthroplasty<br>* A surgical procedure to replace both the tibial and femoral articular surfaces with titanium prostheses.<br>* Other names: Total Knee Replacement;|
| LEGION Porous CR without Hydroxyapatite<br>Patients who have already received or a due to receive a Porous Tibia + LEGION Porous CR without HA femoral component (max 175 subjects) | Procedure: Total Knee Arthroplasty<br>* A surgical procedure to replace both the tibial and femoral articular surfaces with titanium prostheses.<br>* Other names: Total Knee Replacement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survivorship 2 Years Post-Surgery | Implant survivorship is defined as the cumulative proportion of knee implanted components without a revision. | 2 years post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) | KOOS JR assesses patient stiffness (1 item), pain (4 items), and functions of daily living (2 items). Scores range from 0 to 100 with a score of 0 indicating total knee disability and 100 indicating perfect knee health. | Pre-op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years | 
| Patient Reported Outcomes - Oxford Knee Score (OKS) | The OKS contains 12 equally weighted questions on activities of daily living. Responses to each question range from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome. | Pre-op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years | 
| Patient Reported Outcomes - Forgotten Joint Score (FJS) | The FJS questionnaire focuses on the study participant's awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. The FJS for an individual participant is rated on a scale of 1-100 where 100 is the best/max score. | Pre-op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 years | 
| Radiographic Assessment - Implant Position | Implant position will be assessed by the femoral flexion angle, tibial angle, and posterior tibial slope angle from AP and lateral radiographs. | 6 weeks and 6 months | 
| Radiographic Assessment - Implant Migration | Migration will be assessed in accordance with the following definitions: 0. Absent: Absence of progressive radiolucency OR absence of movement of the implant. 1. Present: Presence of progressive radiolucency AND presence of movement of the implant. | 1 year, 2 years, 5 years, and 10 years | 
| Radiographic Assessment - Progressive Radiolucency | Progressive Radiolucency will be assessed in accordance with the following definitions: 0. Absent: No evidence of progressive radiolucency at the bone-cement interface relative to the last measured Radiolucent Line time point. 1. Present: Presence of an increase >1 mm of the Radiolucent Line (Bone-Cement) width and/or new involvement of additional component zones relative to the last measured Radiolucent Line time point. | 1 year, 2 Years, 5 years, and 10 years | 
| Radiographic Assessment - Implant Loosening | Both aseptic and septic component loosening will be evaluated to assess loss of implant fixation with the following definitions: 0. Absent: No evidence of specific imaging features of loosening in the joint space. 1. Present: Presence of apparent imaging features of loosening in the joint space. | 6 months, 1 year, 2 Years, 5 years, and 10 years | 
| Post-Operation Device Related Re-Interventions Related to Operative Knee | Count of device-related re-interventions that occur related to the operative knee post-operation. | Post-op through study completion, approximately 10 years | 
| Implant Survival Rate Up to 10 Years Post-Operation | Survival rate determined by proportion of participants that required no implant revisions. | 1 year, 5 years, and 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthritis, Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Total Knee Arthroplasty (TKA), Knee Replacement, Cementless, Knee, Smith and Nephew