The purpose of this study is to assess the long-term safety and performance of the LEGION Medial Stabilized insert and to generate clinical evidence to support and maintain product registration in global markets.
A). Prospective Subjects: Subject needing primary Total Knee Arthroplasty (TKA) due to degenerative joint disease (primary diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory arthritis.
Pre-operative Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) has been obtained
Post-operative radiographs have been obtained, or these can be collected prospectively in window per schedule of events
12-month post-operative KOOS JR have been obtained, or these can be collected prospectively in window per schedule of events
Subject received revision TKA on the contralateral knee for a previously failed TKA, or Unicondylar Knee Arthroplasty (UKA).
Subject has a Body Mass Index (BMI) ≥ 40 at pre-operative visit.
Subject has ipsilateral hip arthritis resulting in flexion contracture of the hip joint.
At the time of surgery, subject has one or more of the following arthroplasties that are not fully healed and/or well-functioning, in the opinion of the Investigator: Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty; contralateral primary TKA or UKA.
Participants needing primary Total Knee Arthroplasty (TKA) due to degenerative joint disease (primary diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory arthritis. OR Participants which have undergone primary TKA using the investigational product in the past 12 months to repair degenerative joint disease, post-traumatic arthritis or inflammatory arthritis and all the following conditions have been met: * Pre-operative Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) has been obtained * Post-operative radiographs have been obtained, or these can be collected prospectively in window per schedule of events * 12-month post-operative KOOS JR have been obtained, or these can be collected prospectively in window per schedule of events
Cohort
Other
Cemented CoCr
DevicePrimary TKA performed using the LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (CoCr) Femoral component
Cemented Oxinium
DevicePrimary TKA performed using the LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (Ox) Femoral component
Cementless
DevicePrimary TKA performed using the LEGION MS with CONCELOC Tibia with LEGION CR porous (without HA) Femoral component
Implant Survivorship at 10 Years
Implant survivorship at 10 years post-surgery. Implant survivorship is defined as the cumulative proportion of knee-implanted components without a revision. Survivorship is defined as absence of revision of any, or all, of the tibial / femoral / insert components that were implanted during the primary TKA - not including the patella. (Revision is the removal of some, or all, of the above specified implant components, and replacement with new ones for any reason).
Implant Survivorship
Implant survivorship at 6 weeks, 1, 2, 3, 5, 7 years post-surgery. Implant survivorship is defined as the cumulative proportion of knee-implanted components without a revision. Survivorship is defined as absence of revision of any, or all, of the tibial / femoral / insert components that were implanted during the primary TKA - not including the patella. (Revision is the removal of some, or all, of the above specified implant components, and replacement with new ones for any reason).
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR)
The Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) is a validated short form of the KOOS that 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 (i.e., worse outcome) and 100 indicating perfect knee health (i.e., better outcome).
Oxford Knee Score (OKS)
The OKS consists of twelve questions covering function and pain associated with the knee. Scores from the twelve questions are combined to provide an overall score that ranges from 0 to 48, with higher scores indicating better knee function and less pain (i.e., a better outcome)
Forgotten Joint Score (FJS)
The Forgotten Joint Score (FJS) is a patient reported outcome that focuses on the participant's awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. Scores are on a scale of 1 to 100, with higher scores indicating a better outcome.
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