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
NCT ID: NCT05197036
Last Updated: 2024-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
299 participants
OBSERVATIONAL
2021-12-21
2028-12-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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 (min 117 subjects)
Total Knee Arthroplasty
A surgical procedure to replace both the tibial and femoral articular surfaces with titanium prostheses.
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 (min 117 subjects)
Total Knee Arthroplasty
A surgical procedure to replace both the tibial and femoral articular surfaces with titanium prostheses.
Interventions
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Total Knee Arthroplasty
A surgical procedure to replace both the tibial and femoral articular surfaces with titanium prostheses.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Smith & Nephew, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Amir Kamali
Role: STUDY_DIRECTOR
Smith & Nephew, Inc.
Locations
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Emory Orthopaedics and Spine Hospital
Atlanta, Georgia, United States
University of Kentucky
Lexington, Kentucky, 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
UTHealth
Houston, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States
St George and Sutherland Centre for Clinical Orthopaedic Research
Sydney, New South Wales, Australia
OrthoSport Victoria
Melbourne, Victoria, Australia
Robina Hospital
Robina, Victoria, Australia
The Avenue Hospital
Windsor, Victoria, Australia
Concordia Joint Replacement Group
Winnipeg, Manitoba, Canada
Sint Maartenskliniek
Ubbergen, Ubbergen,, Netherlands
Medical Center Leeuwarden
Leeuwarden, , Netherlands
Umeå University Hospital
Umeå, , Sweden
Countries
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Other Identifiers
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POROUS.TKA.SYSTEM.2021.07
Identifier Type: -
Identifier Source: org_study_id
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