| Primary | Change From Pre-op to 1 Year Range of Motion. | Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee. | 106 enrolled knees, 11 of which excluded from the analysis due to:{0 Deaths + 8 Protocol Violations(bilaterals accrued at site where bilateral not allowed, used first knee operated upon: 4 investigational &4 control) + 2 lost to follow up (1 Inv & 1 Contr) + 1 missing outcome (1 Inv & 0 Contr)} | Posted | | Mean | Standard Deviation | Degrees | | 1 year | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| | Units | Counts |
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| Participants | | | Number of Knees | |
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00013.11± 14.89
- OG00110.71± 14.38
|
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| Secondary | To Compare the Change in KOOS Pain Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome). | 106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv & 4Contr)+1 Lost to follow up(1Inv & 0Contr)+2 Missing outcome(1Inv & 1Contr)} | Posted | | Mean | Standard Deviation | Points | | 3-6 months | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in KOOS Pain Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome). | 106 enrolled knees, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (Bilaterals accrued at site where bilaterals are not allowed, used 1st knee operated upon: 4 investigational&4control)+ 2 lost to follow up (1 Inv, 1 Contr)+ 1 missing outcome (0Inv, 1 Contr)} | Posted | | Mean | Standard Deviation | Points | | 1 year | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in KOOS Pain Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome). | 106 enrolled knees, 15 of which excluded from analysis due to:{0 Deaths + 8 Protocol Violation (4 Inv, 4 Contr) + 4 Revisions (1 Inv, 3 Contr) + 3 Lost to follow up (2 Inv, 1 Contr)} | Posted | | Mean | Standard Deviation | Points | | 2 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in KOOS Pain Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome). | This study has been terminated early, therefore the 5 year data was not collected. | Posted | | | | | | 5 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in KOOS Symptoms Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome). | 106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv & 4Contr)+1 Lost to follow up(1Inv & 0Contr)+2 Missing outcome(1Inv & 1Contr)} | Posted | | Mean | Standard Deviation | Points | | 3-6 months | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in KOOS Symptoms Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome). | 106 enrolled knees, 11 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 1 Missing outcome (0 Inv & 1 Contr)} | Posted | | Mean | Standard Deviation | Points | | 1 year | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in KOOS Symptoms Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome). | 106 enrolled knees, 15 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 4 Revisions (1 Inv & 1 Contr)+ 3 Lost to follow up (2 Inv & 1 Contr)} | Posted | | Mean | Standard Deviation | Points | | 2 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in KOOS Symptoms Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome). | This study was terminated early due to a slow recruitment rate. 5 year data not available. | Posted | | | | | | 5 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome). | 106 Enrolled knees, 11 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations(4Inv & 4Contr)+1 Lost to follow up(1Inv & 0Contr)+2 Missing outcome(1Inv & 1Contr)} | Posted | | Mean | Standard Deviation | Points | | 3-6 months | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome). | 106 enrolled knees, 11 of which excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 1 Missing outcome (0 Inv & 1 Contr)} | Posted | | Mean | Standard Deviation | Points | | 1 year | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome). | 106 enrolled knees, 15 of which excluded from the analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr)} | Posted | | Mean | Standard Deviation | Points | | 2 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome). | Study terminated early due to a slow recruitment rate. | Posted | | | | | | 5 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome). | 106 knees enrolled, 11 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 2 Missing outcome (1Inv & 1Contr)} | Posted | | Mean | Standard Deviation | Points | | 3-6 months | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome). | 106 enrolled knees, 13 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 3 Missing outcome (0 Inv & 3 Contr)} | Posted | | Mean | Standard Deviation | Points | | 1 year | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome). | 106 enrolled knees, 16 of which excluded from analysis due to:{0 Deaths+8 Protocol Violations (4 Inv & 4 Contr)+ 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr) + 1 Missing outcome (1 Inv & 0 Contr)} | Posted | | Mean | Standard Deviation | Points | | 2 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome). | Study terminated early due to slow recruitment rate, 5 year data not available. | Posted | | | | | | 5 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome). | 106 knees enrolled, 11 of which excluded from analysis due to:{0 deaths + 8 Protocol Violations + 1 Lost to follow up (1Inv & 0Contr) + 2 Missing outcome (1Inv & 1Contr)} | Posted | | Mean | Standard Deviation | Points | | 3-6 months | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome). | 106 enrolled knees, 13 of which excluded from the analysis due to:{0 Deaths+ 8 Protocol Violations (4 Inv & 4 Contr)+ 2 Lost to follow up (1 Inv & 1 Contr) + 3 Missing outcome (0 Inv & 3 Contr)} | Posted | | Mean | Standard Deviation | Points | | 1 year | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome). | 106 knees enrolled, 16 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv & 4 Contr) + 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr) + 1 Missing outcome (1 Inv & 0 Contr)} | Posted | | Mean | Standard Deviation | Points | | 2 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome). | Study terminated early due to slow recruitment rate. 5 Year data not available. | Posted | | | | | | 5 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | 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. | 106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 1 Missing outcome (1Inv & 0Contr)} | Posted | | Mean | Standard Deviation | Points | | 3 - 6 months | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | 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. | 106 enrolled knees, 11 knees excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv, 4 Contr) + 2 lost to follow up (1 Inv, 1 Contr) + 1 missing outcome (1 Inv, 0 Contr) } | Posted | | Mean | Standard Deviation | Points | | 1 year | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | 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. | 106 enrolled knees, 18 knees excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4 Inv, 4 Contr) + 4 revisions (1 Inv, 1 Contr) + 3 Lost to follow up (2 Inv, 1 Contr) + 3 missing outcome (0 Inv, 3 Cntr)} | Posted | | Mean | Standard Deviation | Points | | 2 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | 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. | Study terminated early due to a slow recruitment rate. 5 year data not available. | Posted | | | | | | 5 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. | 106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 1 Missing outcome (1Inv & 0Contr)} | Posted | | Mean | Standard Deviation | Points | | 3 - 6 months | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. | 106 knees enrolled, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (1Inv & 0Contr)} | Posted | | Mean | Standard Deviation | Points | | 1 year | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. | 106 knees enrolled, 16 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)} | Posted | | Mean | Standard Deviation | Points | | 2 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. | Study terminated early due to a slow recruitment rate. 5 Year data not available. | Posted | | | | | | 5 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
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| Secondary | To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | 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. | 106 knees enrolled, 10 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr) + 1 Missing outcome (0Inv & 1Contr)} | Posted | | Mean | Standard Deviation | Points | | 3 - 6 months | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
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| Secondary | To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | 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. | 106 knees enrolled, 12 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1Inv & 1Contr) + 2 Missing outcome (1Inv & 1Contr)} | Posted | | Mean | Standard Deviation | Points | | 1 year | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
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| Secondary | To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | 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. | 106 knees enrolled, 17 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr) + 2 Missing outcome (0Inv & 2Contr)} | Posted | | Mean | Standard Deviation | Points | | 2 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
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| Secondary | To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | 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. | Study terminated early due to a slow recruitment rate. 5 Year data not available. | Posted | | | | | | 5 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
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| Secondary | To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | 106 knees enrolled, 9 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr)} | Posted | | Mean | Standard Deviation | Points | | 3 - 6 months | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
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| Secondary | To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | 106 knees enrolled, 11 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)} | Posted | | Mean | Standard Deviation | Points | | 1 year | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
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| Secondary | To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | 106 knees enrolled, 15 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)} | Posted | | Mean | Standard Deviation | Points | | 2 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
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| Secondary | To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | Study terminated early to slow recruitment rate. 5 Year data not available. | Posted | | | | | | 5 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
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| Secondary | To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | 106 knees enrolled, 9 of which were excluded from analysis due to:{0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 1 Lost to follow up (1Inv & 0Contr)} | Posted | | Mean | Standard Deviation | Points | | 3 - 6 months | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
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| Secondary | To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | 106 enrolled knees, 11 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 2 Lost to follow up (1 Inv & 1 Contr) + 1 Missing outcome ( 0 Inv & 1 Contr)} | Posted | | Mean | Standard Deviation | Points | | 1 year | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
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| Secondary | To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | 106 enrolled knees, 15 of which excluded from analysis due to: {0 Deaths + 8 Protocol Violations (4Inv & 4Contr) + 4 Revisions (1 Inv & 3 Contr) + 3 Lost to follow up (2 Inv & 1 Contr)} | Posted | | Mean | Standard Deviation | Points | | 2 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
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| Secondary | To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | Study terminated early due to slow recruitment rate. 5 Year data not available. | Posted | | | | | | 5 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
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| Secondary | To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | 106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)} | Posted | | Mean | Standard Deviation | Points | | 3 - 6 months | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | 106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)} | Posted | | Mean | Standard Deviation | Points | | 1 year | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
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| Secondary | To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | 106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)} | Posted | | Mean | Standard Deviation | Points | | 2 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
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| Secondary | To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | Study terminated early due to slow recruitment rate. 5 Year data not available. | Posted | | | | | | 5 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
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| Secondary | To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | 106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)} | Posted | | Mean | Standard Deviation | Points | | 3 - 6 months | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | 106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)} | Posted | | Mean | Standard Deviation | Points | | 1 year | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | 106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)} | Posted | | Mean | Standard Deviation | Points | | 2 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in EQ-5D3L Pain/Discomfort Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | Study terminated early due to slow recruitment rate. 5 Year data not available. | Posted | | | | | | 5 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | 106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)} | Posted | | Mean | Standard Deviation | Points | | 3 - 6 months | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | 106 knees enrolled, 11 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 1 Missing outcome (0Inv & 1Contr)} | Posted | | Mean | Standard Deviation | Points | | 1 year | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | 106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + + 4 Revisions (1Inv & 3Contr) + 3 Lost to follow up (2Inv & 1Contr)} | Posted | | Mean | Standard Deviation | Points | | 2 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | 106 knees enrolled, 9 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 1 Lost to follow up (1Inv & 0Contr)} | Posted | | Mean | Standard Deviation | Points | | 3 - 6 months | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | 106 knees enrolled, 13 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 2 Lost to follow up (1Inv & 1Contr) + 3 Missing outcome (0Inv & 3Contr)} | Posted | | Mean | Standard Deviation | Points | | 1 year | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | 106 knees enrolled, 15 of which excluded from analysis due to:{0Deaths + 8 Protocol Violations (4Inv & 4 Contr) + 4 Revisions (4Inv & 4Contr)+ 3 Lost to follow up (2Inv & 1Contr)} | Posted | | Mean | Standard Deviation | Points | | 2 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |
| Secondary | To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | EQ-5D3L is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state. | Study terminated early due to slow recruitment rate. 5 Year data not available. | Posted | | | | | | 5 years | Number of Knees | Participants | | ID | Title | Description |
|---|
| OG000 | PFC Sigma RP-F | PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | | OG001 | PFC Sigma RP | PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing |
| |