Clinical trial NCT05197036: 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
Official title: A Multi-Centre Study in Patients Undergoing Total Knee Replacement With Smith+Nephew Porous Total Knee Arthroplasty (TKA) System
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis
Post-traumatic Arthritis
Rheumatoid Arthritis
Keywords: Arthritis
Osteoarthritis
Rheumatoid Arthritis
Post-traumatic Arthritis
Total Knee Arthroplasty (TKA)
Knee Replacement
Cementless
Knee
Smith and Nephew
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-19
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Implant Survivorship (femoral and/or tibial component) 2 Years Post-Surgery
timeFrame: 2 years post-surgery
Secondary outcomes:
measure: Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR)
timeFrame: Pre-op, 6 weeks, 6 months, 2 years and 5 years
measure: Patient Reported Outcomes - Oxford Knee Score (OKS)
timeFrame: Pre-op, 6 weeks, 6 months, 2 years and 5 years
measure: Patient Reported Outcomes - Forgotten Joint Score (FJS)
timeFrame: Pre-op, 6 weeks, 6 months, 2 years and 5 years
measure: Radiographic Assessment - Implant Position
timeFrame: 6 months, 2 years and 5 years
measure: Radiographic Assessment - Implant Migration
timeFrame: 6 months, 2 years and 5 years
measure: Radiographic Assessment - Progressive Radiolucency
timeFrame: 6 months, 2 years and 5 years
measure: Radiographic Assessment - Implant Loosening
timeFrame: 6 months, 2 years and 5 years
measure: Post-Operation Device Related Re-Interventions Related to Operative Knee
timeFrame: Post-op through study completion, approximately 5 years
measure: Implant Survival Rate Up to 5 Years Post-Operation
timeFrame: 1 year, 2 years and 5 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Orthopaedics and Spine Hospital
state: Georgia
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Novi
country: United States
facility: The Core Institute
state: Michigan
city: East Syracuse
country: United States
facility: Syracuse Orthopedic Specialists
state: New York
city: New York
country: United States
facility: NYU Langone Health Orthopedic Hospital
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Morrisville
country: United States
facility: Duke Health
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Health
state: Tennessee
city: Houston
country: United States
facility: UTHealth
state: Texas
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Sydney
country: Australia
facility: St George and Sutherland Centre for Clinical Orthopaedic Research
state: New South Wales
city: Melbourne
country: Australia
facility: OrthoSport Victoria
state: Victoria
city: Robina
country: Australia
facility: Robina Hospital
state: Victoria
city: Windsor
country: Australia
facility: The Avenue Hospital
state: Victoria
city: Winnipeg
country: Canada
facility: Concordia Joint Replacement Group
state: Manitoba
city: Ubbergen
country: Netherlands
facility: Sint Maartenskliniek
state: Ubbergen,
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
city: Umeå
country: Sweden
facility: Umeå University Hospital
Study officials:
affiliation: Smith & Nephew, Inc.
name: Amir Kamali
role: STUDY_DIRECTOR
References: