Osteoarthritis
Conditions
Keywords
Sigma, cruciate, retaining, fixed, primary, total, knee, arthroplasty, cemented, osteoarthritis
Brief summary
This study will compare two very similar designs of knee replacement device. One device (Sigma CR150) is a slightly modified version of the original (Sigma CR) and has been modified to enhance/accommodate higher flexion. The original device has been in widespread clinical use with excellent results since 1996 and this study will determine whether the design modifications of the newer device add further value. The newer device has been in clinical use with good short-term(unpublished) outcomes since becoming commercially available in January 2009. Achieving higher knee flexion may be required for cultural reasons or by the increasingly younger, more active patient population undergoing knee replacement today. In addition to promoting flexion, it is also possible that this design change may help the knee replacement to last longer than traditional implants in patients who achieve higher flexion. Therefore, the study will compare the two devices in terms of survivorship, flexion and other measures of the success of a total knee replacement (range of motion, knee-related quality of life, activity and generic quality of life) over the short-term. A minimum of one hundred and forty subjects (minimum 70 per group) with osteoarthritis and aged 50-75 years will be included at UK/international hospitals. Study duration is 2 years and patients will complete standard knee outcome scores plus radiological evaluation. Subjects would receive one of the study devices regardless of their involvement in the study, and apart from (possible)additional visits, x-rays and/or questionnaires, treatment and follow-up care will be as per the care they would receive outside of the study.
Interventions
DEVICESigma CR150
Sigma CR150 femoral component used in combination with the Highly Polished Cobalt Chrome fixed bearing tibial tray and the Curved (XLK) polyethylene bearing (cemented, no patellar resurfacing).
DEVICESigma CR
Sigma CR femoral component used in combination with the Highly Polished Cobalt Chrome fixed bearing tibial tray and the Curved (XLK) polyethylene bearing (cemented, no patellar resurfacing).
Sponsors
DePuy International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
i)Male or female subjects, aged between 50 and 75 years inclusive. ii)Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained. iii) Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. iv) Subjects defined by the Investigator as ASA Grade I or II. v) Subjects with a primary diagnosis of osteoarthritis. vi) Subjects who require a primary total knee arthroplasty. vii) Subjects who can achieve active flexion of 90 degrees.
Exclusion criteria
i) Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation. ii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. iii) Subjects who have participated in a clinical investigation with an investigational product in the last month. iv) Subjects who are currently involved in any injury litigation claims. v) Subjects with an anatomical limb alignment of above 20 degrees varus or valgus. vi) Subjects with a fixed flexion deformity of over 20 degrees. vii) Subjects with recurvatum (definition: hyperextension ≥ 5 degrees). viii) Subjects who cannot flex their hip to 90 degrees. ix) Subjects with a BMI of 35 or above. x) Subjects defined by the Investigator as ASA Grade III-V. xi) Subjects who are identified pre-operatively as having bone defects which require augmentation. xii) Subjects who have previously undergone total or unicondylar knee arthroplasty, high tibial osteotomy, ligament reconstruction, ORIF or with previous fracture in the knee joint. xiii) Subjects with primary or secondary diagnosis of inflammatory or traumatic arthritis. xiv) Subjects who have undergone contralateral total knee arthroplasty during the previous 6 months. xv) Subjects who in the opinion of the Investigator require patellar resurfacing. Intra-operative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Knees Who Survived at 2 Years Post-operative | 2 Years | The Kaplan-Meier success rate at 24-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no components revised for any reason) was censored at the time of last follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Pain Subscore - 1 Year | Pre-operative baseline to 1 year | Comparative evaluation of the change from baseline values at 1 years in Knee Injury and Osteoarthritis Outcome Pain Subscore The subscore ranges from 0 (no pain) to 36 (extreme pain). The subscore is then transformed into a 0 (extreme pain) to 100 (no pain) scale. 100 - (score x 100) / 36 = transformed score |
| Knee Injury and Osteoarthritis Outcome Pain Subscore - 2 Years | 2 years | Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Pain Subscore The subscore ranges from 0 (no pain) to 36 (extreme pain). The subscore is then transformed into a 0 (extreme pain) to 100 (no pain) scale. 100 - (score x 100) / 36 = transformed score |
| Knee Injury and Osteoarthritis Outcome Symptoms Subscore - 1 Years | 1 years | Comparative evaluation of the change from baseline values at 1 year in Knee Injury and Osteoarthritis Outcome Symptom Subscore The subscore ranges from 0 (no symptoms) to 36 (always have symptoms). The subscore is then transformed into a 0 (always have symptoms) to 100 (never have symptoms) scale. 100 - (score x 100) / 36 = transformed score |
| Knee Injury and Osteoarthritis Outcome Symptom Subscore - 2 Years | 2 years | Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Symptom Subscore The subscore ranges from 0 (never have symptoms) to 28 (always have symptoms). The subscore is then transformed into a 0 (always have symptoms) to 100 (never have symptoms) scale. 100 - (score x 100) / 28 = transformed score |
| Knee Injury and Osteoarthritis Outcome - Activities of Daily Living Subscore - 1 Years | 1 year | Comparative evaluation of the change from baseline values at 1 years in Knee Injury and Osteoarthritis Outcome Symptom Subscore The subscore ranges from 0 (no difficulty) to 68 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale. 100 - (score x 100) / 68 = transformed score |
| Knee Injury and Osteoarthritis Outcome - Activities of Daily Living Subscore - 2 Years | 2 year | Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Activities of Daily Living Subscore The subscore ranges from 0 (no difficulty) to 68 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale. 100 - (score x 100) / 68 = transformed score |
| Knee Injury and Osteoarthritis Outcome - Sport and Recreation Subscore - 1 Years | 1 year | Comparative evaluation of the change from baseline values at 1 years in Knee Injury and Osteoarthritis Outcome Activities of Daily Living Subscore The subscore ranges from 0 (no difficulty) to 20 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale. 100 - (score x 100) / 20 = transformed score |
| Knee Injury and Osteoarthritis Outcome Sport and Recreation Subscore - 2 Years | 2 year | Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Activities of Daily Living Subscore The subscore ranges from 0 (no difficulty) to 20 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale. 100 - (score x 100) / 20 = transformed score |
| Knee Injury and Osteoarthritis Outcome - Quality of Life Subscore - 1 Years | 1 year | Comparative evaluation of the change from baseline values at 1 years in Knee Injury and Osteoarthritis Outcome Activities of Quality of life Subscore The subscore ranges from 0 (no difficulty) to 16 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale. 100 - (score x 100) / 16 = transformed score |
| Knee Injury and Osteoarthritis Outcome - Quality of Life Subscore - 2 Years | 2 years | Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Quality of Life Subscore The subscore ranges from 0 (no difficulty) to 16 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale. 100 - (score x 100) / 16 = transformed score |
| Change From Baseline in Goniometer Measured Maximum Passive Flexion at 1 Year. | 1 year | Comparative evaluation of the change from baseline values in 1 year goniometer-measured passive Flexion. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Passive flexion involves moving the leg through range of motion without active muscle contraction |
| Change From Baseline in Goniometer Measured Maximum Passive Extension at 1 Year | 1 year | Comparative evaluation of the change from baseline values in 1 year goniometer-measured passive extension. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Passive extension involves the leg being moved without active muscle contraction |
| Change From Baseline in Goniometer Measured Maximum Passive Extension at 2 Years | 2 year | Comparative evaluation of the change from baseline values in 2 year goniometer-measured passive extension. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Passive extension involves moving the leg without active muscle contraction |
| Change From Baseline in Goniometer Measured Maximum Total Range of Motion at 1 Year | 1 year | Comparative evaluation of the change from baseline values in 1 year goniometer-measured total range of motion. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Total range of motion is the full distance the lower leg travels in relation to the upper leg. |
| Change From Baseline in Goniometer Measured Maximum Passive Flexion at 2 Years | Pre-operative baseline to 2 years | Comparative evaluation of the change from baseline values in 2 year goniometer-measured passive flexion. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg |
| Number of Participants With Flexion Contracture at 1 Year | 1 years | Summary of flexion contracture at 1 year time point. Flexion contracture is a shortening of the muscles that prevents the leg from fully extending |
| Number of Participants With Flexion Contracture at 2 Years | 2 years | Summary of flexion contracture at 2 year time point.Flexion contracture is a shortening of the muscles that prevents the leg from fully extending |
| Total Knee Society Score at 1 Year | 1 year | Total Knee Society Knee Score change from baseline at 1 year The Total Knee Society Score is comprised of two scores: the Knee Score and the Function Score. Both have a 0-100 range. Sub-scales are combined to compute a total score of 100 The Total Knee Society Score is made up of pain, range of motion, alignment and stability subscores. An Excellent score is 80-100, a good score is 70-79, a fair score is 60-69 and a poor score is anything below 60. |
| Total Knee Society Knee Score at 2 Years | 2 years | Total Knee Society Knee Score change from baseline at 2 years The Total Knee Society Score is comprised of two scores: the Knee Score and the Function Score. Both have a 0-100 range. Sub-scales are combined to compute a total score of 100 The Total Knee Society Score is made up of pain, range of motion, alignment and stability subscores. An Excellent score is 80-100, a good score is 70-79, a fair score is 60-69 and a poor score is anything below 60. |
| Anatomic Alignment Angle | 1 year time point | Anatomic angle measured at 1 year time point. If one draws a line from the center of the hip joint to the center of the ankle joint this is considered to be the mechanical axis of the femur. A line drawn through the center of the femoral shaft is the anatomic axis. The angle created at the intersection of these lines is referred to as the anatomic alignment angle. A normal angle is approximately 7-9 degrees valgus or slightly knock-kneed. Varus angles are less common and are also referred to as bow-legged. |
| Alignment - Femoral Component to Anatomic Angle. | 1 year time point | Femoral component angle measured at 1 year time point. This angle is measured between a line drawn from the center of the femoral head and a line across the bottom of the femoral implant (condyles). |
| Alignment - Femoral Component to Anatomic Angle | 2 year time point | Femoral component angle measured at 2 year time point. This angle is measured between a line drawn from the center of the femoral head and a line across the bottom of the femoral implant (condyles). |
| Alignment - Tibial Component to Anatomic Angle | 1 year time point | Tibial component angle measured at 1 year time point. This angle is measured between a line drawn from the center of the femoral head tibial implant. |
| Alignment - Femoral Component Flexion | 1 year time point | Femoral Component Flexion measured at 1 year time point. This measures the angle between a line drawn though the center of the side of the femur and a line drawn across the top of the flat inner surface of the femoral component. |
| Alignment - Tibial Posterior Slope | 1 year time point | Tibial Posterior Slope measured at 1 year time point. This angle is measured between a line through the center of the side of the tibia and the top flat surface of the tibial implant |
| Number of Subjects With Radiolucencies - Femoral Component | 6 to 12 week and 24 month intervals | The bone-implant interface at the femoral components were examined radiographically and radiolucencies were measured in millimeters. Radiolucent lines (RLLs) greater than 2mm are considered to be clinically significant. |
| Number of Subjects With Radiolucencies - Tibial Component | 6 weeks to 24 months | The bone-implant interface at the tibial components were examined radiographically and radiolucencies were measured in millimeters. Radiolucent lines (RLLs) greater than 2mm are considered to be clinically significant. Radiolucent lines greater than 2mm are considered to be clinically significant. |
| Radiographic Evaluation of Maximum Flexion | 1 year time point | Maximum knee flexion measured radiographically at 1 year time point |
| Change From Baseline in Goniometer Measured Maximum Total Range of Motion at 2 Years. | 2 years | Comparative evaluation of the change from baseline values in 2 year goniometer-measured total range of motion. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Total range of motion is the full distance the lower leg travels in relation to the upper leg. |
Countries
India, Singapore, United Kingdom
Participant flow
Recruitment details
191 subjects were recruited at sites in the UK, India and Singapore. Enrollment took place between 3 August 2011 and 21 January 2014
Pre-assignment details
After written informed consent was obtained from subjects, eligibility was confirmed and subjects were allocated a subject identification number
Participants by arm
| Arm | Count |
|---|---|
| Sigma CR 150 Subjects who received a Sigma CR 150 implant | 90 |
| Sigma CR Subjects who received a Sigma CR implant | 88 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 2 |
| Overall Study | developed chronic myopathy | 0 | 1 |
| Overall Study | ligament imbalance | 0 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | Sigma CR 150 | Sigma CR | Total |
|---|---|---|---|
| Age, Continuous | 63.2 Years STANDARD_DEVIATION 6.9 | 64.4 Years STANDARD_DEVIATION 6.2 | 63.8 Years STANDARD_DEVIATION 6.6 |
| BMI | 27.1 kg/m^2 STANDARD_DEVIATION 3.6 | 27.7 kg/m^2 STANDARD_DEVIATION 3.9 | 27.4 kg/m^2 STANDARD_DEVIATION 3.8 |
| Pre-operative flexion angle | 110.8 Degrees STANDARD_DEVIATION 21.4 | 110.4 Degrees STANDARD_DEVIATION 19.4 | 110.6 Degrees STANDARD_DEVIATION 20.4 |
| Primary Diagnosis | 90 Participants | 88 Participants | 178 Participants |
| Sex: Female, Male Female | 61 Participants | 50 Participants | 111 Participants |
| Sex: Female, Male Male | 29 Participants | 38 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 90 | 14 / 88 |
| serious Total, serious adverse events | 9 / 90 | 8 / 88 |
Outcome results
Primary
Percentage of Knees Who Survived at 2 Years Post-operative
The Kaplan-Meier success rate at 24-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no components revised for any reason) was censored at the time of last follow-up.
Time frame: 2 Years
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sigma CR 150 | Percentage of Knees Who Survived at 2 Years Post-operative | 100 Percentage of Knees remaining |
| Sigma CR | Percentage of Knees Who Survived at 2 Years Post-operative | 100 Percentage of Knees remaining |
Secondary
Alignment - Femoral Component Flexion
Femoral Component Flexion measured at 1 year time point. This measures the angle between a line drawn though the center of the side of the femur and a line drawn across the top of the flat inner surface of the femoral component.
Time frame: 1 year time point
Population: Subjects at 1 year within safety population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Alignment - Femoral Component Flexion | 89.74 Degrees | Standard Deviation 2.44 |
| Sigma CR | Alignment - Femoral Component Flexion | 90.10 Degrees | Standard Deviation 2.12 |
Secondary
Alignment - Femoral Component Flexion
Alignment - Femoral Component Flexion measured at 2 year time point. This measures the angle between a line drawn though the center of the side of the femur and a line drawn across the top of the flat inner surface of the femoral component.
Time frame: 2 year time point
Population: Subjects at 2 years within safety population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Alignment - Femoral Component Flexion | 89.93 Degrees | Standard Deviation 2.35 |
| Sigma CR | Alignment - Femoral Component Flexion | 89.80 Degrees | Standard Deviation 2.99 |
Secondary
Alignment - Femoral Component to Anatomic Angle
Femoral component angle measured at 2 year time point. This angle is measured between a line drawn from the center of the femoral head and a line across the bottom of the femoral implant (condyles).
Time frame: 2 year time point
Population: Subjects at 2 year within safety population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Alignment - Femoral Component to Anatomic Angle | 93.94 Degrees | Standard Deviation 2.11 |
| Sigma CR | Alignment - Femoral Component to Anatomic Angle | 94.48 Degrees | Standard Deviation 2.2 |
Secondary
Alignment - Femoral Component to Anatomic Angle.
Femoral component angle measured at 1 year time point. This angle is measured between a line drawn from the center of the femoral head and a line across the bottom of the femoral implant (condyles).
Time frame: 1 year time point
Population: Subjects at 1 year within safety population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Alignment - Femoral Component to Anatomic Angle. | 94.37 Degrees | Standard Deviation 1.95 |
| Sigma CR | Alignment - Femoral Component to Anatomic Angle. | 94.21 Degrees | Standard Deviation 2.64 |
Secondary
Alignment - Tibial Component to Anatomic Angle
Tibial component angle measured at 1 year time point. This angle is measured between a line drawn from the center of the femoral head tibial implant.
Time frame: 1 year time point
Population: Subjects at 1 year within safety population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Alignment - Tibial Component to Anatomic Angle | 89.96 Degrees | Standard Deviation 1.39 |
| Sigma CR | Alignment - Tibial Component to Anatomic Angle | 90.06 Degrees | Standard Deviation 1.83 |
Secondary
Alignment - Tibial Component to Anatomic Angle
Tibial component angle measured at 2 year time point. This angle is measured between a line drawn from the center of the femoral head tibial implant.
Time frame: 2 year time point
Population: Subjects at 2 year within safety population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Alignment - Tibial Component to Anatomic Angle | 89.69 Degrees | Standard Deviation 1.6 |
| Sigma CR | Alignment - Tibial Component to Anatomic Angle | 90.19 Degrees | Standard Deviation 1.98 |
Secondary
Alignment - Tibial Posterior Slope
Alignment - Tibial Posterior Slope measured at 2 year time point. This angle is measured between a line through the center of the side of the tibia and the top flat surface of the tibial implant
Time frame: 2 year time point
Population: Subjects at 2 years within safety population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Alignment - Tibial Posterior Slope | 85.99 Degrees | Standard Deviation 2.29 |
| Sigma CR | Alignment - Tibial Posterior Slope | 85.15 Degrees | Standard Deviation 3.24 |
Secondary
Alignment - Tibial Posterior Slope
Tibial Posterior Slope measured at 1 year time point. This angle is measured between a line through the center of the side of the tibia and the top flat surface of the tibial implant
Time frame: 1 year time point
Population: Subjects at 1 year within safety population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Alignment - Tibial Posterior Slope | 85.95 Degrees | Standard Deviation 2.25 |
| Sigma CR | Alignment - Tibial Posterior Slope | 85.47 Degrees | Standard Deviation 2.62 |
Secondary
Anatomic Alignment Angle
Anatomic angle measured at 2 year time point. If one draws a line from the center of the hip joint to the center of the ankle joint this is considered to be the mechanical axis of the femur. A line drawn through the center of the femoral shaft is the anatomic axis. The angle created at the intersection of these lines is referred to as the anatomic alignment angle. A normal angle is approximately 7-9 degrees valgus or slightly knock-kneed. Varus angles are less common and are also referred to as bow-legged.
Time frame: 2 year time point
Population: Subjects at 2 years within safety population with complete, available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sigma CR 150 | Anatomic Alignment Angle | Varus | 3 Participants |
| Sigma CR 150 | Anatomic Alignment Angle | Valgus | 66 Participants |
| Sigma CR | Anatomic Alignment Angle | Varus | 0 Participants |
| Sigma CR | Anatomic Alignment Angle | Valgus | 65 Participants |
Secondary
Anatomic Alignment Angle
Anatomic angle measured at 1 year time point. If one draws a line from the center of the hip joint to the center of the ankle joint this is considered to be the mechanical axis of the femur. A line drawn through the center of the femoral shaft is the anatomic axis. The angle created at the intersection of these lines is referred to as the anatomic alignment angle. A normal angle is approximately 7-9 degrees valgus or slightly knock-kneed. Varus angles are less common and are also referred to as bow-legged.
Time frame: 1 year time point
Population: Subjects at 1 year within safety population with complete, available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sigma CR 150 | Anatomic Alignment Angle | Varus | 1 Participants |
| Sigma CR 150 | Anatomic Alignment Angle | valgus | 66 Participants |
| Sigma CR | Anatomic Alignment Angle | Varus | 0 Participants |
| Sigma CR | Anatomic Alignment Angle | valgus | 67 Participants |
Secondary
Change From Baseline in Goniometer Measured Maximum Passive Extension at 1 Year
Comparative evaluation of the change from baseline values in 1 year goniometer-measured passive extension. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Passive extension involves the leg being moved without active muscle contraction
Time frame: 1 year
Population: Subjects at one year within per protocol population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Change From Baseline in Goniometer Measured Maximum Passive Extension at 1 Year | -2.34 degrees | Standard Deviation 4.84 |
| Sigma CR | Change From Baseline in Goniometer Measured Maximum Passive Extension at 1 Year | -3.15 degrees | Standard Deviation 6.89 |
Secondary
Change From Baseline in Goniometer Measured Maximum Passive Extension at 2 Years
Comparative evaluation of the change from baseline values in 2 year goniometer-measured passive extension. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Passive extension involves moving the leg without active muscle contraction
Time frame: 2 year
Population: Subjects at 2 years within per protocol population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Change From Baseline in Goniometer Measured Maximum Passive Extension at 2 Years | -2.63 degrees | Standard Deviation 5.14 |
| Sigma CR | Change From Baseline in Goniometer Measured Maximum Passive Extension at 2 Years | -3.44 degrees | Standard Deviation 7.78 |
Secondary
Change From Baseline in Goniometer Measured Maximum Passive Flexion at 1 Year.
Comparative evaluation of the change from baseline values in 1 year goniometer-measured passive Flexion. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Passive flexion involves moving the leg through range of motion without active muscle contraction
Time frame: 1 year
Population: Subjects at 1-year within per protocol population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Change From Baseline in Goniometer Measured Maximum Passive Flexion at 1 Year. | -1.03 degrees | Standard Deviation 12.65 |
| Sigma CR | Change From Baseline in Goniometer Measured Maximum Passive Flexion at 1 Year. | -0.23 degrees | Standard Deviation 12.21 |
Secondary
Change From Baseline in Goniometer Measured Maximum Passive Flexion at 2 Years
Comparative evaluation of the change from baseline values in 2 year goniometer-measured passive flexion. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg
Time frame: Pre-operative baseline to 2 years
Population: Per protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Change From Baseline in Goniometer Measured Maximum Passive Flexion at 2 Years | -3.37 degrees | Standard Deviation 12.97 |
| Sigma CR | Change From Baseline in Goniometer Measured Maximum Passive Flexion at 2 Years | -0.67 degrees | Standard Deviation 11.81 |
Secondary
Change From Baseline in Goniometer Measured Maximum Total Range of Motion at 1 Year
Comparative evaluation of the change from baseline values in 1 year goniometer-measured total range of motion. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Total range of motion is the full distance the lower leg travels in relation to the upper leg.
Time frame: 1 year
Population: Subjects at 1 year within per protocol population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Change From Baseline in Goniometer Measured Maximum Total Range of Motion at 1 Year | 1.31 degrees | Standard Deviation 13.83 |
| Sigma CR | Change From Baseline in Goniometer Measured Maximum Total Range of Motion at 1 Year | 2.92 degrees | Standard Deviation 14.59 |
Secondary
Change From Baseline in Goniometer Measured Maximum Total Range of Motion at 2 Years.
Comparative evaluation of the change from baseline values in 2 year goniometer-measured total range of motion. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Total range of motion is the full distance the lower leg travels in relation to the upper leg.
Time frame: 2 years
Population: Subjects at 2 years within per protocol population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Change From Baseline in Goniometer Measured Maximum Total Range of Motion at 2 Years. | -0.74 degrees | Standard Deviation 14.42 |
| Sigma CR | Change From Baseline in Goniometer Measured Maximum Total Range of Motion at 2 Years. | 2.78 degrees | Standard Deviation 15.99 |
Secondary
Knee Injury and Osteoarthritis Outcome - Activities of Daily Living Subscore - 1 Years
Comparative evaluation of the change from baseline values at 1 years in Knee Injury and Osteoarthritis Outcome Symptom Subscore The subscore ranges from 0 (no difficulty) to 68 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale. 100 - (score x 100) / 68 = transformed score
Time frame: 1 year
Population: Study subjects at 1 year - Subjects within per protocol population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Knee Injury and Osteoarthritis Outcome - Activities of Daily Living Subscore - 1 Years | 44.00 Scores on a scale | Standard Deviation 20.95 |
| Sigma CR | Knee Injury and Osteoarthritis Outcome - Activities of Daily Living Subscore - 1 Years | 39.99 Scores on a scale | Standard Deviation 20.86 |
Secondary
Knee Injury and Osteoarthritis Outcome - Activities of Daily Living Subscore - 2 Years
Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Activities of Daily Living Subscore The subscore ranges from 0 (no difficulty) to 68 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale. 100 - (score x 100) / 68 = transformed score
Time frame: 2 year
Population: Study subjects at 2 years - Subjects within per protocol population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Knee Injury and Osteoarthritis Outcome - Activities of Daily Living Subscore - 2 Years | 38.59 Scores on a scale | Standard Deviation 20.33 |
| Sigma CR | Knee Injury and Osteoarthritis Outcome - Activities of Daily Living Subscore - 2 Years | 40.65 Scores on a scale | Standard Deviation 18.17 |
Secondary
Knee Injury and Osteoarthritis Outcome Pain Subscore - 1 Year
Comparative evaluation of the change from baseline values at 1 years in Knee Injury and Osteoarthritis Outcome Pain Subscore The subscore ranges from 0 (no pain) to 36 (extreme pain). The subscore is then transformed into a 0 (extreme pain) to 100 (no pain) scale. 100 - (score x 100) / 36 = transformed score
Time frame: Pre-operative baseline to 1 year
Population: Subjects within per protocol population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Knee Injury and Osteoarthritis Outcome Pain Subscore - 1 Year | 46.59 Scores on a scale | Standard Deviation 16.68 |
| Sigma CR | Knee Injury and Osteoarthritis Outcome Pain Subscore - 1 Year | 48.54 Scores on a scale | Standard Deviation 16.69 |
Secondary
Knee Injury and Osteoarthritis Outcome Pain Subscore - 2 Years
Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Pain Subscore The subscore ranges from 0 (no pain) to 36 (extreme pain). The subscore is then transformed into a 0 (extreme pain) to 100 (no pain) scale. 100 - (score x 100) / 36 = transformed score
Time frame: 2 years
Population: Study subjects at 2 years - Subjects within per protocol population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Knee Injury and Osteoarthritis Outcome Pain Subscore - 2 Years | 51.50 Scores on a scale | Standard Deviation 17.71 |
| Sigma CR | Knee Injury and Osteoarthritis Outcome Pain Subscore - 2 Years | 55.38 Scores on a scale | Standard Deviation 15.4 |
Secondary
Knee Injury and Osteoarthritis Outcome - Quality of Life Subscore - 1 Years
Comparative evaluation of the change from baseline values at 1 years in Knee Injury and Osteoarthritis Outcome Activities of Quality of life Subscore The subscore ranges from 0 (no difficulty) to 16 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale. 100 - (score x 100) / 16 = transformed score
Time frame: 1 year
Population: Study subjects at 1 years - Subjects within per protocol population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Knee Injury and Osteoarthritis Outcome - Quality of Life Subscore - 1 Years | 50.75 Scores on a scale | Standard Deviation 24.83 |
| Sigma CR | Knee Injury and Osteoarthritis Outcome - Quality of Life Subscore - 1 Years | 49.59 Scores on a scale | Standard Deviation 18.71 |
Secondary
Knee Injury and Osteoarthritis Outcome - Quality of Life Subscore - 2 Years
Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Quality of Life Subscore The subscore ranges from 0 (no difficulty) to 16 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale. 100 - (score x 100) / 16 = transformed score
Time frame: 2 years
Population: Study subjects at 2 years - Subjects within per protocol population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Knee Injury and Osteoarthritis Outcome - Quality of Life Subscore - 2 Years | 60.33 Scores on a scale | Standard Deviation 23.9 |
| Sigma CR | Knee Injury and Osteoarthritis Outcome - Quality of Life Subscore - 2 Years | 59.92 Scores on a scale | Standard Deviation 21.23 |
Secondary
Knee Injury and Osteoarthritis Outcome - Sport and Recreation Subscore - 1 Years
Comparative evaluation of the change from baseline values at 1 years in Knee Injury and Osteoarthritis Outcome Activities of Daily Living Subscore The subscore ranges from 0 (no difficulty) to 20 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale. 100 - (score x 100) / 20 = transformed score
Time frame: 1 year
Population: Study subjects at 1 years - Subjects within per protocol population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Knee Injury and Osteoarthritis Outcome - Sport and Recreation Subscore - 1 Years | 46.99 Scores on a scale | Standard Deviation 32.82 |
| Sigma CR | Knee Injury and Osteoarthritis Outcome - Sport and Recreation Subscore - 1 Years | 46.42 Scores on a scale | Standard Deviation 28.91 |
Secondary
Knee Injury and Osteoarthritis Outcome Sport and Recreation Subscore - 2 Years
Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Activities of Daily Living Subscore The subscore ranges from 0 (no difficulty) to 20 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale. 100 - (score x 100) / 20 = transformed score
Time frame: 2 year
Population: Study subjects at 2 years - Subjects within per protocol population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Knee Injury and Osteoarthritis Outcome Sport and Recreation Subscore - 2 Years | 61.29 Scores on a scale | Standard Deviation 35.6 |
| Sigma CR | Knee Injury and Osteoarthritis Outcome Sport and Recreation Subscore - 2 Years | 60.40 Scores on a scale | Standard Deviation 32.75 |
Secondary
Knee Injury and Osteoarthritis Outcome Symptoms Subscore - 1 Years
Comparative evaluation of the change from baseline values at 1 year in Knee Injury and Osteoarthritis Outcome Symptom Subscore The subscore ranges from 0 (no symptoms) to 36 (always have symptoms). The subscore is then transformed into a 0 (always have symptoms) to 100 (never have symptoms) scale. 100 - (score x 100) / 36 = transformed score
Time frame: 1 years
Population: Study subjects at 1 year - Subjects within per protocol population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Knee Injury and Osteoarthritis Outcome Symptoms Subscore - 1 Years | 44.00 Scores on a scale | Standard Deviation 20.95 |
| Sigma CR | Knee Injury and Osteoarthritis Outcome Symptoms Subscore - 1 Years | 39.99 Scores on a scale | Standard Deviation 20.86 |
Secondary
Knee Injury and Osteoarthritis Outcome Symptom Subscore - 2 Years
Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Symptom Subscore The subscore ranges from 0 (never have symptoms) to 28 (always have symptoms). The subscore is then transformed into a 0 (always have symptoms) to 100 (never have symptoms) scale. 100 - (score x 100) / 28 = transformed score
Time frame: 2 years
Population: Study subjects at 2 year -Subjects within per protocol population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Knee Injury and Osteoarthritis Outcome Symptom Subscore - 2 Years | 38.59 Scores on a scale | Standard Deviation 20.33 |
| Sigma CR | Knee Injury and Osteoarthritis Outcome Symptom Subscore - 2 Years | 40.65 Scores on a scale | Standard Deviation 18.17 |
Secondary
Number of Participants With Flexion Contracture at 1 Year
Summary of flexion contracture at 1 year time point. Flexion contracture is a shortening of the muscles that prevents the leg from fully extending
Time frame: 1 years
Population: Subjects at 1 year within per protocol population with complete, available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sigma CR 150 | Number of Participants With Flexion Contracture at 1 Year | 5-10 degrees | 7 Participants |
| Sigma CR 150 | Number of Participants With Flexion Contracture at 1 Year | 11-15 degrees | 1 Participants |
| Sigma CR | Number of Participants With Flexion Contracture at 1 Year | 5-10 degrees | 5 Participants |
| Sigma CR | Number of Participants With Flexion Contracture at 1 Year | 11-15 degrees | 0 Participants |
Secondary
Number of Participants With Flexion Contracture at 2 Years
Summary of flexion contracture at 2 year time point.Flexion contracture is a shortening of the muscles that prevents the leg from fully extending
Time frame: 2 years
Population: Subjects at 2 years within per protocol population with complete, available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sigma CR 150 | Number of Participants With Flexion Contracture at 2 Years | 5-10 degrees | 4 Participants |
| Sigma CR 150 | Number of Participants With Flexion Contracture at 2 Years | 11-15 degrees | 0 Participants |
| Sigma CR | Number of Participants With Flexion Contracture at 2 Years | 11-15 degrees | 0 Participants |
| Sigma CR | Number of Participants With Flexion Contracture at 2 Years | 5-10 degrees | 2 Participants |
Secondary
Number of Subjects With Radiolucencies - Femoral Component
The bone-implant interface at the femoral components were examined radiographically and radiolucencies were measured in millimeters. Radiolucent lines (RLLs) greater than 2mm are considered to be clinically significant.
Time frame: 6 to 12 week and 24 month intervals
Population: Subjects within safety population with complete, available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sigma CR 150 | Number of Subjects With Radiolucencies - Femoral Component | 6 Weeks to 12 Weeks | 0 Participants |
| Sigma CR 150 | Number of Subjects With Radiolucencies - Femoral Component | 24 months | 2 Participants |
| Sigma CR | Number of Subjects With Radiolucencies - Femoral Component | 6 Weeks to 12 Weeks | 2 Participants |
| Sigma CR | Number of Subjects With Radiolucencies - Femoral Component | 24 months | 1 Participants |
Secondary
Number of Subjects With Radiolucencies - Tibial Component
The bone-implant interface at the tibial components were examined radiographically and radiolucencies were measured in millimeters. Radiolucent lines (RLLs) greater than 2mm are considered to be clinically significant. Radiolucent lines greater than 2mm are considered to be clinically significant.
Time frame: 6 weeks to 24 months
Population: Subjects within safety population with complete, available data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sigma CR 150 | Number of Subjects With Radiolucencies - Tibial Component | 6 Weeks to 12 Weeks | 0 Participants |
| Sigma CR 150 | Number of Subjects With Radiolucencies - Tibial Component | 12 months | 0 Participants |
| Sigma CR | Number of Subjects With Radiolucencies - Tibial Component | 6 Weeks to 12 Weeks | 1 Participants |
| Sigma CR | Number of Subjects With Radiolucencies - Tibial Component | 12 months | 1 Participants |
Secondary
Radiographic Evaluation of Maximum Flexion
Maximum knee flexion measured radiographically at 1 year time point
Time frame: 1 year time point
Population: Subjects at 1 year within safety population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Radiographic Evaluation of Maximum Flexion | 108.51 Degrees | Standard Deviation 18.9 |
| Sigma CR | Radiographic Evaluation of Maximum Flexion | 107.11 Degrees | Standard Deviation 17.41 |
Secondary
Total Knee Society Knee Score at 2 Years
Total Knee Society Knee Score change from baseline at 2 years The Total Knee Society Score is comprised of two scores: the Knee Score and the Function Score. Both have a 0-100 range. Sub-scales are combined to compute a total score of 100 The Total Knee Society Score is made up of pain, range of motion, alignment and stability subscores. An Excellent score is 80-100, a good score is 70-79, a fair score is 60-69 and a poor score is anything below 60.
Time frame: 2 years
Population: Subjects at 2 years within per protocol population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Total Knee Society Knee Score at 2 Years | 46.44 Scores on a scale | Standard Deviation 17.74 |
| Sigma CR | Total Knee Society Knee Score at 2 Years | 54.51 Scores on a scale | Standard Deviation 15.71 |
Secondary
Total Knee Society Score at 1 Year
Total Knee Society Knee Score change from baseline at 1 year The Total Knee Society Score is comprised of two scores: the Knee Score and the Function Score. Both have a 0-100 range. Sub-scales are combined to compute a total score of 100 The Total Knee Society Score is made up of pain, range of motion, alignment and stability subscores. An Excellent score is 80-100, a good score is 70-79, a fair score is 60-69 and a poor score is anything below 60.
Time frame: 1 year
Population: Subjects at 1 year within per protocol population with complete, available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sigma CR 150 | Total Knee Society Score at 1 Year | 45.07 Scores on a scale | Standard Deviation 17.99 |
| Sigma CR | Total Knee Society Score at 1 Year | 52.50 Scores on a scale | Standard Deviation 14.76 |