Osteoarthritis, Knee
Conditions
Brief summary
The primary objective of this investigation is to evaluate the performance (in terms of post-operative active range of motion at one year) of the P.F.C. Sigma and P.F.C. Sigma Rotating Platform total knee systems in clinical practice.
Detailed description
The secondary objectives of this investigation are:To evaluate the performance of the P.F.C. Sigma and P.F.C. Sigma Rotating Platform total knee systems in clinical practice. To evaluate the impact of patellar resurfacing on the performance of the P.F.C. Sigma and the P.F.C. Sigma Rotating Platform total knee systems. To evaluate the impact of Posterior Cruciate Ligament (PCL) sacrifice or retention on the performance of the P.F.C. Sigma and the P.F.C. Sigma Rotating Platform total knee systems.
Interventions
DEVICEP.F.C Sigma Fixed Bearing total knee system
Orthopaedic implant for total knee replacement
DEVICEP.F.C Sigma RP Mobile Bearing knee system
Orthopaedic implant for total knee replacement
Sponsors
DePuy International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects may be recruited to the evaluation. 2. Age - there are no restrictions relating to age of the patient. The patient's age must be considered suitable by the clinical investigator for a bi-compartmental or tri-compartmental knee arthroplasty using either of the two systems available in the evaluation. 3. Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. 4. Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. 5. Subjects who require a bi-compartmental or tri-compartmental knee arthroplasty for primary surgical management of idiopathic osteoarthritis. 6. Patients who in the opinion of the Clinical Investigator are considered to be suitable for treatment with a fixed or mobile bearing knee system and who are suitable for patella resurfacing.
Exclusion criteria
1. Patients who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study. 2. Patients who require revision total knee arthroplasty surgery. 3. Patients with any tibial deformity requiring tibial component augmentation. 4. Patients whom, in the opinion of the Clinical Investigator, require a constrained prosthesis. 5. Patients with Rheumatoid Arthritis. 6. Patients with a pathology which, in the opinion of the Clinical Investigator, will adversely affect healing. 7. Patients with other disorders which, in the opinion of the Clinical Investigator, will / could impair rehabilitation. 8. Contra-indications for use of the device, as detailed in the package insert. 9. Women who are pregnant. 10. Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes. 11. Subjects who are currently involved in another clinical study with an investigational product. 12. Subjects who are currently involved in any injury litigation claims.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 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. |
| To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 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. |
| To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | Change from pre-op to 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. |
| To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | Change from pre-op to 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 Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | Change from pre-op to 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 From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | Change from pre-op to 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 American Knee Society Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | Change from pre-op to 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 Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | Change from pre-op to 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 Knee Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | Change from pre-op to 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 Function Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | Change from pre-op to 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. The function score is composed of walking and stair climbing ability. |
| To Compare the Change in American Knee Society Function Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | Change from pre-op to 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. The function score is composed of walking and stair climbing ability. |
| To Compare the Change in American Knee Society Function Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | Change from pre-op to 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. The function score is composed of walking and stair climbing ability. |
| To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 2 years | Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table. |
| To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 2 years | Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table. |
| To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 2 years | Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table. |
| To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 2 years | Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table. |
| To Compare the Change in SF-12 Physical Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | Change from pre-op to 2 years | The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 \[poor health\] to 100 \[better health\]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12). |
| To Compare the Change in SF-12 Physical Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | Change from pre-op to 2 years | The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 \[poor health\] to 100 \[better health\]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12). |
| To Compare the Change in SF-12 Physical Health Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | Change from pre-op to 5 years | The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 \[poor health\] to 100 \[better health\]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12). |
| To Compare the Change in SF-12 Mental Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | Change from pre-op to 2 years | The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 \[poor health\] to 100 \[better health\]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12). |
| To Compare the Change in SF-12 Mental Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | Change from pre-op to 2 years | The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 \[poor health\] to 100 \[better health\]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12). |
| To Compare the Change in SF-12 Mental Health Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | Change from pre-op to 5 years | The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 \[poor health\] to 100 \[better health\]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12). |
| To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | Change from pre-op to 2 years | The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality. |
| To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | Change from pre-op to 2 years | The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality. |
| To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | Change from pre-op to 5 years | The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality. |
| To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 2 years | Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component. |
| To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 2 years | Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component. |
| To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | Operative | Lateral release is a surgical procedure to release tight capsular structures (lateral retinaculum) on the outside of the kneecap (patella). It is performed during knee surgery and allows the kneecap to move smoothly in the center of the knee. Rate information was collected at time of study surgery. |
| To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | Operative | Lateral release is a surgical procedure to release tight capsular structures (lateral retinaculum) on the outside of the kneecap (patella). It is performed during knee surgery and allows the kneecap to move smoothly in the center of the knee. Rate information was collected at time of study surgery. |
| To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 2 Years | Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed. |
| To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 2 Years | Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed. |
| To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm | 2 Years | Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table. |
| To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm | 2 Years | Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table. |
| To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm | 2 Years | Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table. |
| To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm | 2 Years | Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table. |
| To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm | Change from pre-op to 2 years | The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality. |
| To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm | Change from pre-op to 2 years | The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality. |
| To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | Change from pre-op to 2 years | 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. |
| To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm | Change from pre-op to 5 years | The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality. |
| To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm | Change from pre-op to 5 years | The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality. |
| To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | Change from pre-op to 2 years | 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. |
| To Compare the Change in Range of Motion From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | Change from pre-op to 5 years | 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. |
| To Compare the Change in Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | Change from pre-op to 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. |
Countries
United Kingdom
Participant flow
Pre-assignment details
754 subjects were consented into the study, however only 720 received study treatment.
Participants by arm
| Arm | Count |
|---|---|
| PFC Fixed Bearing PCL Sacrificed PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement | 176 |
| PFC Sigma RP PCL Sacrificed PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement | 176 |
| PFC Sigma Fixed Bearing PCL Retained PFC Sigma Fixed Bearing Total Knee System with PCL Retained
P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement | 170 |
| PFC Sigma RP PCL Retained PFC Sigma Rotating Platform Total Knee System with PCL Retained
P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement | 161 |
| Total | 683 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 18 | 19 | 7 | 5 |
| Overall Study | Does not wish to Continue in Study | 5 | 8 | 3 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 | 2 | 0 |
| Overall Study | Mis-Randomized | 17 | 20 | 0 | 0 |
| Overall Study | Other | 2 | 1 | 1 | 0 |
| Overall Study | Revision | 4 | 1 | 0 | 4 |
| Overall Study | Unsurfaced to Resurfaced Patella | 4 | 4 | 1 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | PFC Fixed Bearing PCL Sacrificed | PFC Sigma RP PCL Sacrificed | PFC Sigma Fixed Bearing PCL Retained | PFC Sigma RP PCL Retained | Total |
|---|---|---|---|---|---|
| Age, Continuous | 69.8 years STANDARD_DEVIATION 8.16 | 70.2 years STANDARD_DEVIATION 7.6 | 70.1 years STANDARD_DEVIATION 7.88 | 69.2 years STANDARD_DEVIATION 8.59 | 69.8 years STANDARD_DEVIATION 8.06 |
| Region of Enrollment United Kingdom | 176 participants | 176 participants | 170 participants | 161 participants | 683 participants |
| Sex: Female, Male Female | 94 Participants | 96 Participants | 102 Participants | 87 Participants | 379 Participants |
| Sex: Female, Male Male | 82 Participants | 80 Participants | 68 Participants | 74 Participants | 304 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 193 | 0 / 196 | 0 / 170 | 0 / 161 |
| serious Total, serious adverse events | 111 / 193 | 107 / 196 | 110 / 170 | 96 / 161 |
Outcome results
Primary
To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm
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: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 158 subjects in the PFC Sigma Fixed Bearing and 155 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 100.6 degrees | Standard Deviation 12.94 |
| PFC Sigma RP PCL Sacrificed | To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 101.6 degrees | Standard Deviation 12.24 |
Primary
To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
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: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 168 subjects in the PFC Sigma Fixed Bearing and 167 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 108.8 degrees | Standard Deviation 13.41 |
| PFC Sigma RP PCL Sacrificed | To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 108.4 degrees | Standard Deviation 12.54 |
Primary
To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm
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: Change from pre-op to 1 year
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 158 subjects in the PFC Sigma Fixed Bearing and 153 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 5.8 degrees | Standard Deviation 15.83 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 8.1 degrees | Standard Deviation 15.74 |
Primary
To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
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: Change from pre-op to 1 year
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 164 subjects in the PFC Sigma Fixed Bearing and 164 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 13.4 degrees | Standard Deviation 17.17 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 12.3 degrees | Standard Deviation 18.7 |
Secondary
To Compare the Change in American Knee Society Function Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm
American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. The function score is composed of walking and stair climbing ability.
Time frame: Change from pre-op to 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 154 subjects in the PFC Sigma Fixed Bearing and 146 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in American Knee Society Function Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 25.0 units on a scale | Standard Deviation 22.51 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in American Knee Society Function Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 23.6 units on a scale | Standard Deviation 19.62 |
Secondary
To Compare the Change in American Knee Society Function Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. The function score is composed of walking and stair climbing ability.
Time frame: Change from pre-op to 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 155 subjects in the PFC Sigma Fixed Bearing and 144 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in American Knee Society Function Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 23.8 units on a scale | Standard Deviation 22.18 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in American Knee Society Function Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 26.1 units on a scale | Standard Deviation 21.47 |
Secondary
To Compare the Change in American Knee Society Function Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. The function score is composed of walking and stair climbing ability.
Time frame: Change from pre-op to 5 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 124 subjects in the PFC Sigma Fixed Bearing and 125 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in American Knee Society Function Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 20.3 units on a scale | Standard Deviation 24.54 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in American Knee Society Function Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 20.5 units on a scale | Standard Deviation 22.06 |
Secondary
To Compare the Change in American Knee Society Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm
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: Change from pre-op to 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 152 subjects in the PFC Sigma Fixed Bearing and 143 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in American Knee Society Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 50.7 units on a scale | Standard Deviation 21.02 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in American Knee Society Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 49.5 units on a scale | Standard Deviation 24.67 |
Secondary
To Compare the Change in American Knee Society Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
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: Change from pre-op to 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 154 subjects in the PFC Sigma Fixed Bearing and 143 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in American Knee Society Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 57.2 units on a scale | Standard Deviation 18.66 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in American Knee Society Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 56.8 units on a scale | Standard Deviation 18.09 |
Secondary
To Compare the Change in American Knee Society Knee Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
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: Change from pre-op to 5 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 122 subjects in the PFC Sigma Fixed Bearing and 120 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in American Knee Society Knee Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 57.9 units on a scale | Standard Deviation 19.42 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in American Knee Society Knee Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 55.6 units on a scale | Standard Deviation 20.36 |
Secondary
To Compare the Change in Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm
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: Change from pre-op to 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 145 subjects in the PFC Sigma Fixed Bearing and 138 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | -19.1 units on a scale | Standard Deviation 8.35 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | -17.6 units on a scale | Standard Deviation 9.92 |
Secondary
To Compare the Change in Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
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: Change from pre-op to 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 134 subjects in the PFC Sigma Fixed Bearing and 118 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | -18.8 units on a scale | Standard Deviation 9.93 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | -18.1 units on a scale | Standard Deviation 8.9 |
Secondary
To Compare the Change in Oxford Knee Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
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: Change from pre-op to 5 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 114 subjects in the PFC Sigma Fixed Bearing and 111 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in Oxford Knee Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | -20.4 units on a scale | Standard Deviation 10.33 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in Oxford Knee Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | -19.9 units on a scale | Standard Deviation 8.95 |
Secondary
To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm
The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.
Time frame: Change from pre-op to 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 77 subjects in the PFC Sigma Fixed Bearing and 70 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm | 10.3 units on a scale | Standard Deviation 6.72 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm | 7.5 units on a scale | Standard Deviation 8.25 |
Secondary
To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm
The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.
Time frame: Change from pre-op to 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 75 subjects in the PFC Sigma Fixed Bearing and 71 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm | 8.8 units on a scale | Standard Deviation 7.03 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm | 9.4 units on a scale | Standard Deviation 6.37 |
Secondary
To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm
The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.
Time frame: Change from pre-op to 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 153 subjects in the PFC Sigma Fixed Bearing and 144 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 10.6 units on a scale | Standard Deviation 7.14 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 9.7 units on a scale | Standard Deviation 7.35 |
Secondary
To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.
Time frame: Change from pre-op to 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 152 subjects in the PFC Sigma Fixed Bearing and 141 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 9.6 units on a scale | Standard Deviation 6.89 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 8.4 units on a scale | Standard Deviation 7.4 |
Secondary
To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm
The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.
Time frame: Change from pre-op to 5 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 62 subjects in the PFC Sigma Fixed Bearing and 60 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm | 11.2 units on a scale | Standard Deviation 6.57 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm | 8.1 units on a scale | Standard Deviation 8.94 |
Secondary
To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm
The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.
Time frame: Change from pre-op to 5 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 60 subjects in the PFC Sigma Fixed Bearing and 62 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm | 8.9 units on a scale | Standard Deviation 7.35 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm | 9.1 units on a scale | Standard Deviation 7.16 |
Secondary
To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.
Time frame: Change from pre-op to 5 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 122 subjects in the PFC Sigma Fixed Bearing and 122 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 10.0 units on a scale | Standard Deviation 7.04 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 8.6 units on a scale | Standard Deviation 8.07 |
Secondary
To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm
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: Change from pre-op to 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 8.7 degrees | Standard Deviation 14.74 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 10.2 degrees | Standard Deviation 15.72 |
Secondary
To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
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: Change from pre-op to 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 156 subjects in the PFC Sigma Fixed Bearing and 148 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 13.9 degrees | Standard Deviation 15.81 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 12.0 degrees | Standard Deviation 17.99 |
Secondary
To Compare the Change in Range of Motion From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
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: Change from pre-op to 5 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 123 subjects in the PFC Sigma Fixed Bearing and 124 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in Range of Motion From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 15.2 degrees | Standard Deviation 15.46 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in Range of Motion From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 14.5 degrees | Standard Deviation 18.77 |
Secondary
To Compare the Change in SF-12 Mental Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm
The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 \[poor health\] to 100 \[better health\]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).
Time frame: Change from pre-op to 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 139 subjects in the PFC Sigma Fixed Bearing and 130 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in SF-12 Mental Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 1.86 units on a scale | Standard Deviation 12.69 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in SF-12 Mental Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 0.26 units on a scale | Standard Deviation 11.86 |
Secondary
To Compare the Change in SF-12 Mental Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 \[poor health\] to 100 \[better health\]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).
Time frame: Change from pre-op to 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 130 subjects in the PFC Sigma Fixed Bearing and 118 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in SF-12 Mental Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 0.67 units on a scale | Standard Deviation 10.71 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in SF-12 Mental Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 1.91 units on a scale | Standard Deviation 10.27 |
Secondary
To Compare the Change in SF-12 Mental Health Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 \[poor health\] to 100 \[better health\]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).
Time frame: Change from pre-op to 5 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 107 subjects in the PFC Sigma Fixed Bearing and 109 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in SF-12 Mental Health Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 1.51 units on a scale | Standard Deviation 12.74 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in SF-12 Mental Health Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 1.98 units on a scale | Standard Deviation 10.64 |
Secondary
To Compare the Change in SF-12 Physical Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm
The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 \[poor health\] to 100 \[better health\]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).
Time frame: Change from pre-op to 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 139 subjects in the PFC Sigma Fixed Bearing and 130 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in SF-12 Physical Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 10.47 units on a scale | Standard Deviation 10.76 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in SF-12 Physical Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 9.68 units on a scale | Standard Deviation 11.38 |
Secondary
To Compare the Change in SF-12 Physical Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 \[poor health\] to 100 \[better health\]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).
Time frame: Change from pre-op to 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 130 subjects in the PFC Sigma Fixed Bearing and 118 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in SF-12 Physical Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 12.38 units on a scale | Standard Deviation 11.23 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in SF-12 Physical Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 10.96 units on a scale | Standard Deviation 11.97 |
Secondary
To Compare the Change in SF-12 Physical Health Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 \[poor health\] to 100 \[better health\]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12).
Time frame: Change from pre-op to 5 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 107 subjects in the PFC Sigma Fixed Bearing and 109 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Change in SF-12 Physical Health Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 10.90 units on a scale | Standard Deviation 11.84 |
| PFC Sigma RP PCL Sacrificed | To Compare the Change in SF-12 Physical Health Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 8.75 units on a scale | Standard Deviation 12.47 |
Secondary
To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm
Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component.
Time frame: 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 9 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 20 percentage of participants |
Secondary
To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component.
Time frame: 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 9 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 14 percentage of participants |
Secondary
To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component.
Time frame: 5 Years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 8 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 6 percentage of participants |
Secondary
To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm
Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.
Time frame: 5 Years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm | 66 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm | 64 percentage of participants |
Secondary
To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm
Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.
Time frame: 2 Years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm | 88 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm | 86 percentage of participants |
Secondary
To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm
Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.
Time frame: 2 Years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm | 88 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm | 83 percentage of participants |
Secondary
To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm
Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.
Time frame: 5 Years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm | 65 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm | 71 percentage of participants |
Secondary
To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm
Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.
Time frame: 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 81 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 82 percentage of participants |
Secondary
To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.
Time frame: 5 Years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 65 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 68 percentage of participants |
Secondary
To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.
Time frame: 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 88 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 85 percentage of participants |
Secondary
To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm
Lateral release is a surgical procedure to release tight capsular structures (lateral retinaculum) on the outside of the kneecap (patella). It is performed during knee surgery and allows the kneecap to move smoothly in the center of the knee. Rate information was collected at time of study surgery.
Time frame: Operative
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 7 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 7 percentage of participants |
Secondary
To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
Lateral release is a surgical procedure to release tight capsular structures (lateral retinaculum) on the outside of the kneecap (patella). It is performed during knee surgery and allows the kneecap to move smoothly in the center of the knee. Rate information was collected at time of study surgery.
Time frame: Operative
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 10 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 10 percentage of participants |
Secondary
To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm
Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.
Time frame: 5 Years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm | 57 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm | 53 percentage of participants |
Secondary
To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm
Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.
Time frame: 2 Years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 87 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm | 72 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm | 66 percentage of participants |
Secondary
To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm
Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.
Time frame: 2 Years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm | 75 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm | 69 percentage of participants |
Secondary
To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm
Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.
Time frame: 5 Years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 88 subjects in the PFC Sigma Fixed Bearing and 89 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm | 65 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm | 54 percentage of participants |
Secondary
To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm
Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.
Time frame: 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 76 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 76 percentage of participants |
Secondary
To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.
Time frame: 2 years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 73 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 67 percentage of participants |
Secondary
To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.
Time frame: 5 Years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 61 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 53 percentage of participants |
Secondary
To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm
Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.
Time frame: 2 Years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 170 subjects in the PFC Sigma Fixed Bearing and 161 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 99.4 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm | 98.1 percentage of participants |
Secondary
To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.
Time frame: 2 Years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 98.9 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 98.3 percentage of participants |
Secondary
To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.
Time frame: 5 Years
Population: Due to consent withdrawals, deaths, lost to follow up, revisions, subjects whose patella were resurfaced, mis-randomized, those who did not wish to continue in the study, and incomplete or unavailable assessments, 176 subjects in the PFC Sigma Fixed Bearing and 176 subjects in the PFC Sigma RP Treatment Groups were available for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PFC Fixed Bearing PCL Sacrificed | To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 96.3 percentage of participants |
| PFC Sigma RP PCL Sacrificed | To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm | 97.6 percentage of participants |