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

Sponsor

Smith & Nephew, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05197036

Collaborator

(none)

500

Enrollment

Locations

155.6

Anticipated Duration (Months)

250

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis Post-traumatic Arthritis Rheumatoid Arthritis	Procedure: Total Knee Arthroplasty

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 10 years post-surgery.

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 21, 2021

Anticipated Primary Completion Date :

Dec 10, 2026

Anticipated Study Completion Date :

Dec 10, 2034

Arms and Interventions

Arm	Intervention/Treatment
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 (max 250 subjects)	Procedure: Total Knee Arthroplasty A surgical procedure to replace both the tibial and femoral articular surfaces with titanium prostheses. Other Names: Total Knee Replacement
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 (max 250 subjects)	Procedure: Total Knee Arthroplasty A surgical procedure to replace both the tibial and femoral articular surfaces with titanium prostheses. Other Names: Total Knee Replacement

Arm

Intervention/Treatment

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 (max 250 subjects)

Procedure: Total Knee Arthroplasty

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

Other Names:

Total Knee Replacement

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 (max 250 subjects)

Procedure: Total Knee Arthroplasty

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

Other Names:

Total Knee Replacement

Outcome Measures

Primary Outcome Measures

Implant Survivorship 2 Years Post-Surgery [2 years post-surgery]
Implant survivorship is defined as the cumulative proportion of knee implanted components without a revision.

Secondary Outcome Measures

Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) [Pre-op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 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.
Patient Reported Outcomes - Oxford Knee Score (OKS) [Pre-op, 6 weeks, 6 months, 1 year, 2 years, 5 years, and 10 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, 1 year, 2 years, 5 years, and 10 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 weeks and 6 months]
Implant position will be assessed by the femoral flexion angle, tibial angle, and posterior tibial slope angle from AP and lateral radiographs.
Radiographic Assessment - Implant Migration [1 year, 2 years, 5 years, and 10 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 - Progressive Radiolucency [1 year, 2 Years, 5 years, and 10 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 Loosening [6 months, 1 year, 2 Years, 5 years, and 10 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.
Post-Operation Device Related Re-Interventions Related to Operative Knee [Post-op through study completion, approximately 10 years]
Count of device-related re-interventions that occur related to the operative knee post-operation.
Implant Survival Rate Up to 10 Years Post-Operation [1 year, 5 years, and 10 years]
Survival rate determined by proportion of participants that required no implant revisions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. Subject needing primary TKA due to degenerative joint disease (primary diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory arthritis.

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.