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The study was terminated at 2 years as investigators were unable to continue participation in the study.
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The primary objective of this investigation is to determine the survivorship of the LCS Complete AP Glide mobile bearing knee prosthesis at 5 years.
The secondary objectives of this investigation are to evaluate the clinical performance of the LCS® Complete AP Glide mobile bearing knee prosthesis and to determine its long-term survivorship.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L.C.S. APG Knee Anterior Posterior Glide knee | Other | Orthopaedic implant for primary knee replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L.C.S. APG Knee Anterior Posterior Glide knee | Device | Orthopaedic implant for primary knee replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| A survival analysis of the LCS® Complete AP Glide knee prosthesis at five years. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline to 3 months post-operative assessment in:Clinical outcome (stability, pain, range of motion and function), using the American Knee Society Score. | American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability. American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong-A University medical centre | Pusan | South Korea | ||||
| Ewha Womans University Mokdong Hospital |
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| Pre-op to 3 months |
| Change from baseline to 1 year post-operative assessment in clinical outcome (stability, pain, range of motion and function) using the American Society Score | American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability. American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee | Pre-op to 1 year |
| Change from baseline to 3 year post-operative assessment in clinical outcome (stability, pain, range of motion and function) using the American Society Score | American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability. American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee | Pre-op to 3 years |
| Incidence of anterior knee pain and patellar function using the Patellar Score | The Patellar Score is a 1 to 30 point outcome score (where 30 indicates the best outcome) that evaluates the patella of the affected knee. The patellar score is composed of Anterior Knee Pain (max 15 points), Quadriceps Strength (max 5 points), Ability to rise from chair (max 5 points), and Stair-climbing (max 5 points). | 3 months post-operatively |
| Incidence of anterior knee pain and patellar function using the Patellar Score | The Patellar Score is a 1 to 30 point outcome score (where 30 indicates the best outcome) that evaluates the patella of the affected knee. The patellar score is composed of Anterior Knee Pain (max 15 points), Quadriceps Strength (max 5 points), Ability to rise from chair (max 5 points), and Stair-climbing (max 5 points). | 1 year post-operatively |
| Incidence of anterior knee pain and patellar function using the Patellar Score | The Patellar Score is a 1 to 30 point outcome score (where 30 indicates the best outcome) that evaluates the patella of the affected knee. The patellar score is composed of Anterior Knee Pain (max 15 points), Quadriceps Strength (max 5 points), Ability to rise from chair (max 5 points), and Stair-climbing (max 5 points). | 3 year post-operatively |
| Patient derived outcome in terms of joint specific quality of life, as determined by the Oxford Knee Score | The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function. | 3 months post-operatively |
| Patient derived outcome in terms of joint specific quality of life, as determined by the Oxford Knee Score | The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function. | 1 year post-operatively |
| Patient derived outcome in terms of joint specific quality of life, as determined by the Oxford Knee Score | The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function. | 3 years post-operatively |
| Patient derived outcome in terms of general quality of life, as determined by the SF-12 | The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12). At times, the survey is also displayed via 8 domain scales that are also scored from 0 to 100 (where 100 indicates the highest level of health) as follows: Physical Function, Role Physical, Bodily Pain, General Health, Mental Health, Role Emotional, Social Function, and Vitality. | 3 months post-operatively |
| Patient derived outcome in terms of general quality of life, as determined by the SF-12 | The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12). At times, the survey is also displayed via 8 domain scales that are also scored from 0 to 100 (where 100 indicates the highest level of health) as follows: Physical Function, Role Physical, Bodily Pain, General Health, Mental Health, Role Emotional, Social Function, and Vitality. | 1 year post-operatively |
| Patient derived outcome in terms of general quality of life, as determined by the SF-12 | The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12). At times, the survey is also displayed via 8 domain scales that are also scored from 0 to 100 (where 100 indicates the highest level of health) as follows: Physical Function, Role Physical, Bodily Pain, General Health, Mental Health, Role Emotional, Social Function, and Vitality. | 3 years post-operatively |
| A survival analysis of the LCS Complete AP Glide knee prosthesis | Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40* devices are left still being followed. | 1 year post-operatively |
| A survival analysis of the LCS Complete AP Glide knee prosthesis | Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40* devices are left still being followed. | 3 years post-operatively |
| Assessment of component alignment and positioning | 3 months post-operatively |
| Assessment of component alignment and positioning | 1 year post-operatively |
| Assessment of component alignment and positioning | 3 years post-operatively |
| Assessment of radiolucencies | 3 months post-operatively |
| Assessment of radiolucencies | 1 year post-operatively |
| Assessment of radiolucencies | 3 years post-operatively |
| Assessment of Patella Tilt and patellofemoral alignment | 3 months, 1 yr, and 3 yrs |
| Seoul |
| South Korea |
| Severance Hospital, Yongsei University College of Medicine | Seoul | South Korea |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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