Phase
Condition
Rheumatoid Arthritis
Dermatomyositis (Connective Tissue Disease)
Musculoskeletal Diseases
Treatment
Total Knee Arthroplasty
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- A) Subject needing primary TKA due to degenerative joint disease (primary diagnosisof osteoarthritis), post-traumatic arthritis or inflammatory arthritis. OR B) Subject has undergone primary TKA with Smith+Nephew Porous knee system in past 12months to repair degenerative joint disease, post- traumatic arthritis orinflammatory 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 collectedprospectively in window per schedule of events
Subject agrees to consent and to follow the prospective study visit schedule (asdefined in the study protocol and informed consent form) by signing the IndependentReview Board (IRB)/Independent Ethics Committee (IEC) approved informed consentform.
Subject is willing to attend study follow-up visits for up to five (5) yearspost-surgery.
Subject is able to read, understand, and communicate responses to Patient ReportedOutcome assessments.
Subject is 18-80 years old (inclusive).
Exclusion
Exclusion Criteria:
Subject received TKA on the contralateral knee as a revision for a previously failedtotal 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 arthroplastiesthat are not fully healed and well-functioning, as determined by the investigator:Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacingarthroplasty; 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 neuromusculardisease).
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 treatedwith an investigational product in the past 30 days.
Subject, in the opinion of the Investigator, has an emotional or neurologicalcondition that would pre-empt their ability or willingness to participate in thestudy including mental illness, drug or alcohol abuse.
Subject is known to be at risk for lost to follow-up, or failure to return forscheduled visits.
Women who are pregnant, nursing, or of child-bearing potential who are not utilizinghighly effective birth control measures.
Subjects who have participated previously in this clinical trial and who have beenwithdrawn.
Study Design
Study Description
Connect with a study center
St George and Sutherland Centre for Clinical Orthopaedic Research
Sydney, New South Wales
AustraliaSite Not Available
OrthoSport Victoria
Melbourne, Victoria 3121
AustraliaSite Not Available
Robina Hospital
Robina, Victoria 3121
AustraliaSite Not Available
The Avenue Hospital
Windsor, Victoria 3181
AustraliaSite Not Available
Concordia Joint Replacement Group
Winnipeg, Manitoba R2K2M9
CanadaSite Not Available
Sint Maartenskliniek
Ubbergen, Ubbergen, 6574
NetherlandsSite Not Available
Medical Center Leeuwarden
Leeuwarden, 8934
NetherlandsSite Not Available
Umeå University Hospital
Umeå, 90737
SwedenSite Not Available
Orthopaedic Specialists of Connecticut
Brookfield, Connecticut 06804
United StatesSite Not Available
Emory Orthopaedics and Spine Hospital
Atlanta, Georgia 30084
United StatesSite Not Available
University of Kentucky
Lexington, Kentucky 40506
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
The Core Institute
Novi, Michigan 48374
United StatesSite Not Available
Syracuse Orthopedic Specialists
East Syracuse, New York 13057
United StatesSite Not Available
Columbia University
New York, New York 10032
United StatesSite Not Available
NYU Langone Health Orthopedic Hospital
New York, New York 10016
United StatesSite Not Available
Duke Health
Morrisville, North Carolina 27560
United StatesSite Not Available
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Erlanger Health
Chattanooga, Tennessee 37403
United StatesSite Not Available
UTHealth
Houston, Texas 77401
United StatesSite Not Available
University of Wisconsin
Madison, Wisconsin 52718
United StatesSite Not Available
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