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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Post-traumatic Arthritis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia
      • St George and Sutherland Centre for Clinical Orthopaedic Research
  • Victoria
    • Melbourne, Victoria, Australia, 3121
      • OrthoSport Victoria
    • Robina, Victoria, Australia, 3121
      • Robina Hospital
    • Windsor, Victoria, Australia, 3181
      • The Avenue Hospital
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2K2M9
      • Concordia Joint Replacement Group
• Netherlands
  • Leeuwarden, Netherlands, 8934
    • Medical Center Leeuwarden
  • Ubbergen,
    • Ubbergen, Ubbergen,, Netherlands, 6574
      • Sint Maartenskliniek
• Sweden
  • Umeå, Sweden, 90737
    • Umeå University Hospital
• United States
  • Connecticut
    • Brookfield, Connecticut, United States, 06804
      • Orthopaedic Specialists of Connecticut
  • Georgia
    • Atlanta, Georgia, United States, 30084
      • Emory Orthopaedics and Spine Hospital
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Novi, Michigan, United States, 48374
      • The Core Institute
  • New York
    • East Syracuse, New York, United States, 13057
      • Syracuse Orthopedic Specialists
    • New York, New York, United States, 10032
      • Columbia University
    • New York, New York, United States, 10016
      • NYU Langone Health Orthopedic Hospital
  • North Carolina
    • Morrisville, North Carolina, United States, 27560
      • Duke Health
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Health
  • Texas
    • Houston, Texas, United States, 77401
      • UTHealth
  • Wisconsin
    • Madison, Wisconsin, United States, 52718
      • University Of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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
   • 12-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 ten (10) 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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 175 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 175 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Director: Amir Kamali, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2021
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): December 10, 2034

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Arthritis; Osteoarthritis; Knee; Rheumatoid Arthritis; Total Knee Arthroplasty (TKA); Knee Replacement; Cementless; Post-traumatic Arthritis; Smith and Nephew
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Osteoarthritis
• Other Study ID Numbers: POROUS.TKA.SYSTEM.2021.07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No