Knee Osteoarthritis
Conditions
Keywords
Arthroplasty, Replacement, Knee, PFC Sigma RPF, PFC Sigma RP
Brief summary
The main objective of this study is to determine if the P.F.C. Sigma RP-F Knee delivers a greater post-operative range of motion (ROM) compared with the P.F.C. Sigma RP Knee in primary TKA. The secondary objectives of this investigation are to evaluate the clinical and patient outcomes and survivorship associated with the DePuy P.F.C. Sigma RP-F and RP Posterior Stabilised (PS) Knee over 5 years.
Detailed description
Primary Outcome: Change from pre-operative range of motion at 1 year between patients receiving P.F.C. Sigma RP vs P.F.C. Sigma RP-F Secondary endpoints: Comparative evaluation of any post-operative variation between subjects receiving primary TKA with either of the above devices in terms of Knee and Osteoarthritis Scores (KOOS), American Knee Society Score (AKS), EQ-5D Score and Oxford Knee Score (OKS)
Interventions
DEVICEPFC Sigma RP-F
An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
DEVICEPFC Sigma RP
An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
Sponsors
DePuy International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects, aged between 45 and 75 years inclusive. * Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained. * Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. * Subjects who present with osteoarthritis that in the opinion of the clinical investigator requires a primary total knee arthroplasty. * Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with either the P.F.C Sigma RP-F or the P.F.C Sigma RP knee, according to the indications specified in the package insert leaflet. * Subjects who have authorised the transfer of his/her pseudonymised information to DePuy.
Exclusion criteria
* Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation. * Female subjects who are pregnant or lactating. * Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. * Subjects who have participated in a clinical investigation with an investigational product in the last month( 30 days). * Subjects who are currently involved in any injury litigation claims. * Subjects with a known history of poor compliance to medical treatment. * Subjects who have previously had an osteotomy or significant surgery in the affected knee.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Pre-op to 1 Year Range of Motion. | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 1 year | 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). |
| 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. | 2 years | 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). |
| 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. | 5 years | 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). |
| 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. | 3 - 6 months | 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. |
| 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. | 3-6 months | 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). |
| 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. | 1 year | 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). |
| 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. | 2 years | 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). |
| 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. | 5 years | 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). |
| 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. | 3-6 months | 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). |
| 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. | 1 year | 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). |
| 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. | 2 years | 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). |
| 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. | 5 years | 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). |
| 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. | 3-6 months | 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). |
| 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. | 1 year | 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). |
| 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. | 2 years | 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). |
| 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. | 2 years | American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. |
| 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. | 5 years | 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). |
| 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. | 3-6 months | 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). |
| 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. | 1 year | 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). |
| 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. | 2 years | 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). |
| 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. | 5 years | 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). |
| 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. | 1 year | 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. |
| 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. | 2 years | 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. |
| 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. | 5 years | 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. |
| 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. | 3 - 6 months | American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. |
| 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. | 1 year | American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. |
| 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. | 5 years | American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. |
| 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. | 3 - 6 months | 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. |
| 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. | 1 year | 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. |
| 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. | 2 years | 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. |
| 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. | 5 years | 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. |
| 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. | 3 - 6 months | 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. |
| 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. | 1 year | 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. |
| 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. | 2 years | 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. |
| 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. | 5 years | 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. |
| 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. | 3 - 6 months | 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. |
| 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. | 1 year | 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. |
| 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. | 2 years | 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. |
| 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. | 5 years | 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. |
| 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. | 3 - 6 months | 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. |
| 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. | 1 year | 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. |
| 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. | 2 years | 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. |
| 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. | 5 years | 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. |
| To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | 3 - 6 months | 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. |
| 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. | 5 years | 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. |
| 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. | 3 - 6 months | 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. |
| 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. | 3-6 months | 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). |
| 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. | 2 years | 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. |
| 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. | 3 - 6 months | 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. |
| 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. | 1 year | 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. |
| 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. | 2 years | 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. |
| 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. | 5 years | 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. |
| 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. | 1 year | 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. |
Countries
Spain, United Kingdom
Participant flow
Recruitment details
2 sites enrolled 106 knees in 98 subjects who were then randomized into 2 groups, 50 into the PFC Sigma RP-F group and 56 into the PFC Sigma RP group.
Pre-assignment details
Study protocol was designed and executed on using 'knees' as study units.
Participants by arm
| Arm | Count |
|---|---|
| PFC Sigma RP-F 125 patients to be allocated to this arm according to blinding envelopes
PFC Sigma RP-F : An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing | 50 |
| PFC Sigma RP 125 patients to be allocated to this arm according to blinding envelopes
PFC Sigma RP : An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing | 56 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 4 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Protocol Violation | 4 | 4 |
Baseline characteristics
| Characteristic | PFC Sigma RP | Total | PFC Sigma RP-F |
|---|---|---|---|
| Age, Continuous | 66.3 years STANDARD_DEVIATION 6.4 | 65.8 years STANDARD_DEVIATION 6.8 | 65.2 years STANDARD_DEVIATION 7.2 |
| Region of Enrollment Spain | 52 participants | 100 participants | 48 participants |
| Region of Enrollment United Kingdom | 4 participants | 6 participants | 2 participants |
| Sex: Female, Male Female | 42 Participants | 72 Participants | 30 Participants |
| Sex: Female, Male Male | 14 Participants | 34 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 56 |
| serious Total, serious adverse events | 7 / 50 | 7 / 56 |
Outcome results
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.
Time frame: 1 year
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | Change From Pre-op to 1 Year Range of Motion. | 13.11 Degrees | Standard Deviation 14.89 |
| PFC Sigma RP | Change From Pre-op to 1 Year Range of Motion. | 10.71 Degrees | Standard Deviation 14.38 |
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.
Time frame: 1 year
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 30.5 Points | Standard Deviation 19.3 |
| PFC Sigma RP | 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. | 30.1 Points | Standard Deviation 19.9 |
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.
Time frame: 2 years
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 24.9 Points | Standard Deviation 18.4 |
| PFC Sigma RP | 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. | 26.5 Points | Standard Deviation 18.1 |
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.
Time frame: 3 - 6 months
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 25.0 Points | Standard Deviation 19.6 |
| PFC Sigma RP | 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. | 28.9 Points | Standard Deviation 17.3 |
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.
Time frame: 5 years
Population: Study terminated early due to a slow recruitment rate. 5 Year data not available.
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.
Time frame: 1 year
Population: 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) }
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 40.0 Points | Standard Deviation 17.6 |
| PFC Sigma RP | 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. | 38.9 Points | Standard Deviation 17.2 |
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.
Time frame: 2 years
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 37.3 Points | Standard Deviation 20.6 |
| PFC Sigma RP | 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. | 36.8 Points | Standard Deviation 19.6 |
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.
Time frame: 3 - 6 months
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 36.3 Points | Standard Deviation 17.9 |
| PFC Sigma RP | 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. | 39.1 Points | Standard Deviation 15.7 |
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.
Time frame: 5 years
Population: Study terminated early due to a slow recruitment rate. 5 year data not available.
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.
Time frame: 1 year
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | -0.24 Points | Standard Deviation 0.65 |
| PFC Sigma RP | 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. | -0.24 Points | Standard Deviation 0.62 |
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.
Time frame: 2 years
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | -0.21 Points | Standard Deviation 0.8 |
| PFC Sigma RP | 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. | -0.17 Points | Standard Deviation 0.63 |
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.
Time frame: 3 - 6 months
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | -0.27 Points | Standard Deviation 0.72 |
| PFC Sigma RP | 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. | -0.27 Points | Standard Deviation 0.63 |
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.
Time frame: 1 year
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | -0.62 Points | Standard Deviation 0.58 |
| PFC Sigma RP | 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. | -0.50 Points | Standard Deviation 0.58 |
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.
Time frame: 2 years
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | -0.58 Points | Standard Deviation 0.63 |
| PFC Sigma RP | 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. | -0.48 Points | Standard Deviation 0.58 |
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.
Time frame: 3 - 6 months
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | -0.58 Points | Standard Deviation 0.62 |
| PFC Sigma RP | 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. | -0.58 Points | Standard Deviation 0.57 |
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.
Time frame: 5 years
Population: Study terminated early to slow recruitment rate. 5 Year data not available.
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.
Time frame: 5 years
Population: Study terminated early due to slow recruitment rate. 5 Year data not available.
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.
Time frame: 1 year
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | -0.11 Points | Standard Deviation 0.49 |
| PFC Sigma RP | 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. | -0.22 Points | Standard Deviation 0.58 |
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.
Time frame: 2 years
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | -0.07 Points | Standard Deviation 0.51 |
| PFC Sigma RP | 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. | -0.15 Points | Standard Deviation 0.55 |
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.
Time frame: 3 - 6 months
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | -0.04 Points | Standard Deviation 0.56 |
| PFC Sigma RP | 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. | -0.19 Points | Standard Deviation 0.56 |
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.
Time frame: 5 years
Population: Study terminated early due to slow recruitment rate. 5 Year data not available.
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.
Time frame: 1 year
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | -0.53 Points | Standard Deviation 0.63 |
| PFC Sigma RP | 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. | -0.48 Points | Standard Deviation 0.61 |
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.
Time frame: 2 years
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | -0.42 Points | Standard Deviation 0.59 |
| PFC Sigma RP | 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. | -0.44 Points | Standard Deviation 0.58 |
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.
Time frame: 3 - 6 months
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | -0.40 Points | Standard Deviation 0.65 |
| PFC Sigma RP | 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. | -0.50 Points | Standard Deviation 0.58 |
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.
Time frame: 5 years
Population: Study terminated early due to slow recruitment rate. 5 Year data not available.
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.
Time frame: 1 year
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 20.6 Points | Standard Deviation 26.5 |
| PFC Sigma RP | 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. | 13.6 Points | Standard Deviation 26.5 |
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.
Time frame: 2 years
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 10.8 Points | Standard Deviation 24.7 |
| PFC Sigma RP | 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. | 11.4 Points | Standard Deviation 26.2 |
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.
Time frame: 3 - 6 months
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 18.3 Points | Standard Deviation 23.7 |
| PFC Sigma RP | 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. | 16.4 Points | Standard Deviation 23.3 |
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.
Time frame: 5 years
Population: Study terminated early due to slow recruitment rate. 5 Year data not available.
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).
Time frame: 1 year
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 41.5 Points | Standard Deviation 18.5 |
| PFC Sigma RP | 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. | 44.0 Points | Standard Deviation 23 |
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).
Time frame: 2 years
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 39.6 Points | Standard Deviation 18.7 |
| PFC Sigma RP | 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. | 42.5 Points | Standard Deviation 23.5 |
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).
Time frame: 3-6 months
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 36.0 Points | Standard Deviation 18.7 |
| PFC Sigma RP | 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. | 43.7 Points | Standard Deviation 20.1 |
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).
Time frame: 5 years
Population: Study terminated early due to a slow recruitment rate.
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).
Time frame: 1 year
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 45.0 Points | Standard Deviation 20.5 |
| PFC Sigma RP | 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. | 48.9 Points | Standard Deviation 19.4 |
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).
Time frame: 2 years
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 43.3 Points | Standard Deviation 21.3 |
| PFC Sigma RP | 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. | 47.8 Points | Standard Deviation 20.1 |
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).
Time frame: 3-6 months
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 39.7 Points | Standard Deviation 21.7 |
| PFC Sigma RP | 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. | 46.5 Points | Standard Deviation 18 |
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).
Time frame: 5 years
Population: This study has been terminated early, therefore the 5 year data was not collected.
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).
Time frame: 1 year
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 49.0 Points | Standard Deviation 29 |
| PFC Sigma RP | 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. | 51.7 Points | Standard Deviation 27.7 |
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).
Time frame: 2 years
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 44.3 Points | Standard Deviation 31.6 |
| PFC Sigma RP | 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. | 50.8 Points | Standard Deviation 23.6 |
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).
Time frame: 3-6 months
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 42.2 Points | Standard Deviation 26.7 |
| PFC Sigma RP | 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. | 48.0 Points | Standard Deviation 26.2 |
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).
Time frame: 5 years
Population: Study terminated early due to slow recruitment rate. 5 Year data not available.
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).
Time frame: 1 year
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 35.4 Points | Standard Deviation 27.7 |
| PFC Sigma RP | 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. | 33.5 Points | Standard Deviation 25.1 |
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).
Time frame: 2 years
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 36.6 Points | Standard Deviation 27.8 |
| PFC Sigma RP | 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. | 37.8 Points | Standard Deviation 25.3 |
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).
Time frame: 3-6 months
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 14.4 Points | Standard Deviation 22.3 |
| PFC Sigma RP | 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. | 17.4 Points | Standard Deviation 24.7 |
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).
Time frame: 5 years
Population: Study terminated early due to slow recruitment rate, 5 year data not available.
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).
Time frame: 1 year
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 29.8 Points | Standard Deviation 21.7 |
| PFC Sigma RP | 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. | 30.5 Points | Standard Deviation 22.1 |
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).
Time frame: 2 years
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 30.5 Points | Standard Deviation 20.9 |
| PFC Sigma RP | 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. | 33.5 Points | Standard Deviation 25 |
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).
Time frame: 3-6 months
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | 23.1 Points | Standard Deviation 18.4 |
| PFC Sigma RP | 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. | 32.4 Points | Standard Deviation 21.1 |
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).
Time frame: 5 years
Population: This study was terminated early due to a slow recruitment rate. 5 year data not available.
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.
Time frame: 1 year
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | -18.7 Points | Standard Deviation 8.6 |
| PFC Sigma RP | 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. | -19.4 Points | Standard Deviation 8.7 |
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.
Time frame: 2 years
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | -17.3 Points | Standard Deviation 9.7 |
| PFC Sigma RP | 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. | -19.1 Points | Standard Deviation 9.6 |
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.
Time frame: 3 - 6 months
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | 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. | -14.4 Points | Standard Deviation 8.8 |
| PFC Sigma RP | 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. | -18.0 Points | Standard Deviation 8.7 |
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.
Time frame: 5 years
Population: Study terminated early due to a slow recruitment rate. 5 Year data not available.
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.
Time frame: 3 - 6 months
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | -0.56 Points | Standard Deviation 0.81 |
| PFC Sigma RP | To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | -0.67 Points | Standard Deviation 0.83 |
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.
Time frame: 2 years
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | -0.72 Points | Standard Deviation 0.83 |
| PFC Sigma RP | To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | -0.60 Points | Standard Deviation 0.82 |
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.
Time frame: 1 year
Population: 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)}
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Sigma RP-F | To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | -0.67 Points | Standard Deviation 0.77 |
| PFC Sigma RP | To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups. | -0.68 Points | Standard Deviation 0.82 |