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
- Conditions
- OsteoarthritisRheumatoid ArthritisPost-traumatic Arthritis
- Interventions
- Procedure: Total Knee Arthroplasty
- Registration Number
- NCT05197036
- Lead Sponsor
- Smith & Nephew, Inc.
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 299
-
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
-
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).
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description LEGION Porous CR without Hydroxyapatite Total Knee Arthroplasty Patients who have already received or a due to receive a Porous Tibia + LEGION Porous CR without HA femoral component (min 117 subjects) LEGION Porous CR with Hydroxyapatite Total Knee Arthroplasty Patients who have already received or a due to receive a Porous Tibia + LEGION Porous CR with HA femoral component (min 117 subjects)
- Primary Outcome Measures
Name Time Method Implant Survivorship (femoral and/or tibial component) 2 Years Post-Surgery 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.
- Secondary Outcome Measures
Name Time Method Patient Reported Outcomes - Oxford Knee Score (OKS) Pre-op, 6 weeks, 6 months, 2 years and 5 years 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.
Patient Reported Outcomes - Forgotten Joint Score (FJS) Pre-op, 6 weeks, 6 months, 2 years and 5 years 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.
Radiographic Assessment - Implant Position 6 months, 2 years and 5 years Implant position will be assessed by the femoral flexion angle, tibial angle, and posterior tibial slope angle from AP and lateral radiographs.
Post-Operation Device Related Re-Interventions Related to Operative Knee Post-op through study completion, approximately 5 years Count of device-related re-interventions that occur related to the operative knee post-operation.
Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) Pre-op, 6 weeks, 6 months, 2 years and 5 years 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.
Radiographic Assessment - Progressive Radiolucency 6 months, 2 years and 5 years 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.Radiographic Assessment - Implant Migration 6 months, 2 years and 5 years 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.Radiographic Assessment - Implant Loosening 6 months, 2 years and 5 years 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.Implant Survival Rate Up to 5 Years Post-Operation 1 year, 2 years and 5 years Survivorship of the implant will be defined as the cumulative proportion of all knee implant components without a revision.
Trial Locations
- Locations (21)
The Core Institute
🇺🇸Novi, Michigan, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Duke Health
🇺🇸Morrisville, North Carolina, United States
Syracuse Orthopedic Specialists
🇺🇸East Syracuse, New York, United States
OrthoSport Victoria
🇦🇺Melbourne, Victoria, Australia
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
UTHealth
🇺🇸Houston, Texas, United States
Erlanger Health
🇺🇸Chattanooga, Tennessee, United States
St George and Sutherland Centre for Clinical Orthopaedic Research
🇦🇺Sydney, New South Wales, Australia
Sint Maartenskliniek
🇳🇱Ubbergen, Ubbergen,, Netherlands
Medical Center Leeuwarden
🇳🇱Leeuwarden, Netherlands
Umeå University Hospital
🇸🇪Umeå, Sweden
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Concordia Joint Replacement Group
🇨🇦Winnipeg, Manitoba, Canada
Emory Orthopaedics and Spine Hospital
🇺🇸Atlanta, Georgia, United States
NYU Langone Health Orthopedic Hospital
🇺🇸New York, New York, United States
Columbia University
🇺🇸New York, New York, United States
The Avenue Hospital
🇦🇺Windsor, Victoria, Australia
Robina Hospital
🇦🇺Robina, Victoria, Australia
University of Kentucky
🇺🇸Lexington, Kentucky, United States