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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.
This is a post market, prospective and retro-prospective, multicentered 10-year observational study. The study is looking at the LEGION Medial Stabilized insert used in primary total knee arthroplasty alongside specific tibia and femur component combinations. There will be 144 knees enrolled across 3 cohorts in the study. All enrolled knees will undergo a primary knee arthroplasty due to degenerative joint disease (primary diagnosis of osteoarthritis), post-traumatic arthritis or inflammatory arthritis. Enrolled subjects will be followed up for 10 years post operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cemented CoCr | LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (CoCr) Femoral component |
| |
| Cemented Oxinium | LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (Ox) Femoral component |
| |
| Cementless | LEGION MS with CONCELOC Tibia with LEGION CR porous (without HA) Femoral component |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cemented CoCr | Device | Primary TKA performed using the LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (CoCr) Femoral component |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
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.
OR
B). Retro-prospective Subjects: Subject has 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:
Subject's treating clinician has decided the study device is suitable for the subjects TKA procedure and the study device is used in line with the applicable Instructions For Use (IFU) (listed in section 6).
Subject agrees to consent and follow the prospective study visit schedule up to 10 years post-surgery (as defined in the study protocol and informed consent form) by signing the Independent Review Board (IRB)/Independent Ethics Committee (IEC) approved consent form.
Subject is able to read, understand and communicate responses to Patient Reported Outcome Measure (PROM).
Subject is 18-80 years old at the time of consent (inclusive).
Exclusion Criteria:
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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:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alice Kitching | Contact | +44 7590001182 | Alice.Kitching@smith-nephew.com | |
| Galit Reske | Contact | +972 54427344 | Galit.Reske@smith-nephew.com |
| Name | Affiliation | Role |
|---|---|---|
| Anasua Ganguly | Smith & Nephew, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Core Institute | Phoenix | Arizona | 85023 | United States |
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| Cemented Oxinium | Device | Primary TKA performed using the LEGION MS with Cemented Tibia (JII) with LEGION CR non-porous (Ox) Femoral component |
|
| Cementless | Device | Primary TKA performed using the LEGION MS with CONCELOC Tibia with LEGION CR porous (without HA) Femoral component |
|
| 6 weeks, 1 year, 2 years, 3 years, 5 years, and 7 years |
| 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). | 6 weeks, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years |
| 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) | 6 weeks, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years |
| 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. | 6 weeks, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years |
| Five-Level EuroQol Five-Dimensional (EQ-5D-5L): Index Score | The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The descriptive system (i.e., index score) is used to describe the participant's health state and consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate their health state by marking the most appropriate statement in each of the five areas. The EQ-5D-5L Index Score was based on a scale of 0 to 1, with higher index values indicating better health and lower index values indicating worse health. | 6 weeks, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years |
| Five-Level EuroQol Five-Dimensional (EQ-5D-5L): Visual Analogue Scale Score | The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale (VAS). The VAS records the participant's self-rated health on a vertical visual analogue scale. The scale ranges from 0 to 100 where 0 indicates 'The worst health you can imagine' and 100 indicates 'The best health you can imagine'. | 6 weeks, 1 year, 2 years, 3 years, 5 years, 7 years, and 10 years |
| Rothman Orthopedics-Advent Health | Orlando | Florida | 32803 | United States |
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| Newton Wellesley Hospital | Newton | Massachusetts | 02462 | United States |
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| New York University Hospital | New York | New York | 10016 | United States |
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| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| University of Wisconsin | Madison | Wisconsin | 53715-1218 | United States |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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