Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Osteoarthritis
Post-traumatic Arthritis
Eligibility:
All Genders
18-80 years
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 st...
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 ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
December 21 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 25 2028
Estimated Enrollment :
299 Patients enrolled
Trial Details
Trial ID
NCT05197036
Start Date
December 21 2021
End Date
December 25 2028
Last Update
August 6 2024
Active Locations (21)
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1
Emory Orthopaedics and Spine Hospital
Atlanta, Georgia, United States, 30084
2
University of Kentucky
Lexington, Kentucky, United States, 40506
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
The Core Institute
Novi, Michigan, United States, 48374