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

N/AActive Not RecruitingNCT05197036

Smith & Nephew, Inc.299 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

299

Conditions

Osteoarthritis Post-traumatic Arthritis Rheumatoid Arthritis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (18)

Emory Orthopaedics and Spine Hospital

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

The Core Institute

Novi, Michigan, United States

Syracuse Orthopedic Specialists

East Syracuse, New York, United States

NYU Langone Health Orthopedic Hospital

New York, New York, United States

Columbia University

New York, New York, United States

Duke Health

Morrisville, North Carolina, United States

Oregon Health & Science University

Portland, Oregon, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Erlanger Health

Chattanooga, Tennessee, United States

...and 8 more locations

Outcomes

Primary Outcomes

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.

Time frame: 2 years post-surgery

Secondary Outcomes

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.

Time frame: Pre-op, 6 weeks, 6 months, 2 years, 3 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.

Time frame: Pre-op, 6 weeks, 6 months, 2 years, 3 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.

Time frame: Pre-op, 6 weeks, 6 months, 2 years, 3 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.

Time frame: 6 months, 2 years, 5 years and 10 years

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.

Time frame: 6 months, 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.

Time frame: 6 months, 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.

Time frame: 6 months, 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.

Time frame: Post-op through study completion, approximately 10 years

Implant Survival Rate Up to 10 Years Post-Operation

Survivorship of the implant will be defined as the cumulative proportion of all knee implant components without a revision.

Time frame: 1 year, 2 years, 5 years and 10 years