Non-inflammatory Arthritis
Conditions
Keywords
Total Knee Replacement, Flexion, Range of Motion, Activities of Daily Living, Implant design, Subject Satisfaction, Non-inflammatory arthritis
Brief summary
This study will evaluate whether design features of one implant design allows more knee bend than the other. Patients will have 1 design in the left knee and 1 design in their right knee. Both knee surgeries will be on the same day.
Detailed description
The primary objective of this study is to determine whether the passive, non-weight-bearing flexion is superior with the posterior-stabilized PFC® Sigma™ RP-F compared to the posterior-stabilized PFC® Sigma™ RP in bilateral Subjects receiving both implants and if this difference is a function of implant design.
Interventions
DEVICETotal knee replacement using the PFC Sigma RPF knee implant.
Total knee replacement
DEVICETotal knee replacement using the PFC Sigma RP knee implant
Total knee replacement
Sponsors
DePuy Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Non-Inflammatory Arthritis * Age = 40-70 years * Male or female * Suitable for devices in study * Needing primary simultaneous bilateral knee replacements * Willing to consent and authorize release of personal health information * Subjects who are able to understand this clinical investigation, co-operate with investigational procedures and are willing to return to the clinic, hospital and predefined physical therapy centers for all the required postoperative follow-ups,
Exclusion criteria
* Existing conditions that would compromise participation * Multiple joint involvement * Pregnant/lactating women * Inflammatory arthritis * Fixed flexion contracture greater than 20 degrees * Previous knee replacement of any type * Needing device(s) not specified in protocol * The Subject is a known drug or alcohol abuser or has a psychological disorder that would compromise follow-up * Those who have participated in an investigation in the last 3 months * Those involved in personal injury litigation, medical-legal or workers compensation claims * Failure to follow surgical technique details specified in the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Passive Flexion at 6 Months | 6 months | The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Specific Anthropometrics | Collected at pre-op | Various Patient specific anthropometrics were examined to assess their potential influence and interaction on post-op outcomes. |
| American Knee Society (AKS) Score | Collected Pre-operative, 2 and 6 weeks and 6 and 12 months follow up. Reporting for final 12-month interval | AKS Score post-op at 12-months is reported for the final visit AKS score is a 0 -100-point scale with 100 being best knee condition. |
| KOOS Pain Sub-score | Pre-operative, 2 and 6 weeks and 6 and 12 months and analyzed and reported for pre-op, 6- and 12-months follow up | KOOS is a self-reported outcome measure assessing the patient's opinion about health, symptoms, and functionality of their knee. There are 5 sub-scales: symptoms, pain activity of daily living, sports/recreation and quality of life. Further, the sub-score for pain is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. |
| Subgroup Analysis - Passive Flexion Analyzed and Reported for Pre-op, 6- and 12-months, for Subjects With Less Than 120 Degrees Passive Flexion Pre-op in Either Knee | Collected at Pre-operative, 2 and 6 weeks and 6- and 12-months, analyzed and reported for pre-op, 6- and 12-months | The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device. |
| Patellar Crepitus Defined as No Crepitus, FINE or COARSE | Collected at Pre-operative, 6 weeks and 6 and 12 months | Patellar Crepitus (grinding in the knee) analyzed and reported for pre-op, 6-months and 12-months and classified as No Crepitus, FINE or COARSE. |
| Subject Satisfaction | Collected pre-and post-op, reported at 12-months | Secondary objective to compare the pre-op goals and post-op satisfaction through the interpretation of data collected with the use of Palm technology for bilateral knee patients |
| Single Leg Active Flexion (SLAF) | Pre-op, 6- and 12-months | Weight-bearing single leg active flexion (SLAF). A medically trained professional conducts this test using a goniometer, which is an angle-measuring device. Of note, pre-op patients have a lower number because they were unable or unwilling to participate in SLAF due to pain. |
| Ability to Perform Activities of Daily Living (ADLs) as Per the KOOS Sub-scale for ADLs | Collected at pre-operative, 2 and 6 weeks and 6 and 12 months, analyzed and reported for pre-op, 6 and 12-months | KOOS is a self-reported outcome measure assessing the patient's opinion about health, symptoms, and functionality of their knee. There are 5 sub-scales: symptoms, pain, activity of daily living, sports/recreation and quality of life. The score is a percentage score from 0 to 100 with 0 representing extreme problems and 100 representing no problems. |
Countries
United States
Participant flow
Recruitment details
There were eight clinical investigators participating in the investigation. Subjects who were to receive simultaneous bilateral knee replacement were recruited for this study, where one knee was to receive the PFC Sigma Rotating Platform high flexion (RP-F) device and the other knee was to receive the PFC Sigma Rotating Platform (RP) device. 93 Subjects were enrolled in the study.
Pre-assignment details
The randomization was a two stage scheme in order to minimize bias that could potentially be introduced due to differences in preoperative range of motion (ROM) between a subject's right and left legs.
Participants by arm
| Arm | Count |
|---|---|
| PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee. | 93 |
| PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee. | 93 |
| PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee. | 91 |
| PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee. | 91 |
| Total | 368 |
Baseline characteristics
| Characteristic | PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement | PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement | Total |
|---|---|---|---|
| Age, Continuous | 61.4 years STANDARD_DEVIATION 5.6 | 61.4 years STANDARD_DEVIATION 5.7 | 61.4 years STANDARD_DEVIATION 5.8 |
| Region of Enrollment United States United States | 93 knees | 91 knees | 184 knees |
| Sex: Female, Male Female | 61 knees | 60 knees | 121 knees |
| Sex: Female, Male Male | 32 knees | 31 knees | 63 knees |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 93 | 8 / 91 |
| serious Total, serious adverse events | 3 / 93 | 2 / 91 |
Outcome results
Primary
Knee Society Passive Flexion at 6 Months
The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Passive Flexion for Standard Knee Device at Pre-op | Knee Society Passive Flexion at 6 Months | 124.2 Degrees of passive flexion | Standard Deviation 11.2 |
| Passive Flexion for Standard Knee Device at 6-months | Knee Society Passive Flexion at 6 Months | 124.0 Degrees of passive flexion | Standard Deviation 10.6 |
Secondary
Ability to Perform Activities of Daily Living (ADLs) as Per the KOOS Sub-scale for ADLs
KOOS is a self-reported outcome measure assessing the patient's opinion about health, symptoms, and functionality of their knee. There are 5 sub-scales: symptoms, pain, activity of daily living, sports/recreation and quality of life. The score is a percentage score from 0 to 100 with 0 representing extreme problems and 100 representing no problems.
Time frame: Collected at pre-operative, 2 and 6 weeks and 6 and 12 months, analyzed and reported for pre-op, 6 and 12-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Passive Flexion for Standard Knee Device at Pre-op | Ability to Perform Activities of Daily Living (ADLs) as Per the KOOS Sub-scale for ADLs | 49.0 Points on a scale | Standard Deviation 20.2 |
| Passive Flexion for Standard Knee Device at 6-months | Ability to Perform Activities of Daily Living (ADLs) as Per the KOOS Sub-scale for ADLs | 85.4 Points on a scale | Standard Deviation 14 |
| Passive Flexion for Standard Knee Device at 12-months | Ability to Perform Activities of Daily Living (ADLs) as Per the KOOS Sub-scale for ADLs | 90.4 Points on a scale | Standard Deviation 11.8 |
| Passive Flexion for High Flexion Knee Device at Pre-op | Ability to Perform Activities of Daily Living (ADLs) as Per the KOOS Sub-scale for ADLs | 47.9 Points on a scale | Standard Deviation 19.2 |
| Passive Flexion for High Flexion Knee Device at 6-months | Ability to Perform Activities of Daily Living (ADLs) as Per the KOOS Sub-scale for ADLs | 85.6 Points on a scale | Standard Deviation 12.7 |
| Passive Flexion for High Flexion Knee Device at 12-months | Ability to Perform Activities of Daily Living (ADLs) as Per the KOOS Sub-scale for ADLs | 90.1 Points on a scale | Standard Deviation 11.3 |
Secondary
American Knee Society (AKS) Score
AKS Score post-op at 12-months is reported for the final visit AKS score is a 0 -100-point scale with 100 being best knee condition.
Time frame: Collected Pre-operative, 2 and 6 weeks and 6 and 12 months follow up. Reporting for final 12-month interval
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Passive Flexion for Standard Knee Device at Pre-op | American Knee Society (AKS) Score | 85.6 Units on a scale | Standard Deviation 11.5 |
| Passive Flexion for Standard Knee Device at 6-months | American Knee Society (AKS) Score | 87.0 Units on a scale | Standard Deviation 10.7 |
Secondary
KOOS Pain Sub-score
KOOS is a self-reported outcome measure assessing the patient's opinion about health, symptoms, and functionality of their knee. There are 5 sub-scales: symptoms, pain activity of daily living, sports/recreation and quality of life. Further, the sub-score for pain is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Time frame: Pre-operative, 2 and 6 weeks and 6 and 12 months and analyzed and reported for pre-op, 6- and 12-months follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Passive Flexion for Standard Knee Device at Pre-op | KOOS Pain Sub-score | 45.7 Units on a scale | Standard Deviation 19.2 |
| Passive Flexion for Standard Knee Device at 6-months | KOOS Pain Sub-score | 84.0 Units on a scale | Standard Deviation 14.8 |
| Passive Flexion for Standard Knee Device at 12-months | KOOS Pain Sub-score | 89.5 Units on a scale | Standard Deviation 14 |
| Passive Flexion for High Flexion Knee Device at Pre-op | KOOS Pain Sub-score | 45.3 Units on a scale | Standard Deviation 18.2 |
| Passive Flexion for High Flexion Knee Device at 6-months | KOOS Pain Sub-score | 83.1 Units on a scale | Standard Deviation 14.9 |
| Passive Flexion for High Flexion Knee Device at 12-months | KOOS Pain Sub-score | 90.0 Units on a scale | Standard Deviation 11.8 |
Secondary
Patellar Crepitus Defined as No Crepitus, FINE or COARSE
Patellar Crepitus (grinding in the knee) analyzed and reported for pre-op, 6-months and 12-months and classified as No Crepitus, FINE or COARSE.
Time frame: Collected at Pre-operative, 6 weeks and 6 and 12 months
Population: Patellar crepitus is measured by touch with the clinician placing a hand over the knee cap and moving the lower leg from flexion to extension. It is classified as coarse, fine or no crepitus.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Passive Flexion for Standard Knee Device at Pre-op | Patellar Crepitus Defined as No Crepitus, FINE or COARSE | FINE Crepitus | 31 Knees |
| Passive Flexion for Standard Knee Device at Pre-op | Patellar Crepitus Defined as No Crepitus, FINE or COARSE | NO Crepitus | 15 Knees |
| Passive Flexion for Standard Knee Device at Pre-op | Patellar Crepitus Defined as No Crepitus, FINE or COARSE | COARSE Crepitus | 45 Knees |
| Passive Flexion for Standard Knee Device at 6-months | Patellar Crepitus Defined as No Crepitus, FINE or COARSE | FINE Crepitus | 37 Knees |
| Passive Flexion for Standard Knee Device at 6-months | Patellar Crepitus Defined as No Crepitus, FINE or COARSE | NO Crepitus | 13 Knees |
| Passive Flexion for Standard Knee Device at 6-months | Patellar Crepitus Defined as No Crepitus, FINE or COARSE | COARSE Crepitus | 42 Knees |
| Passive Flexion for Standard Knee Device at 12-months | Patellar Crepitus Defined as No Crepitus, FINE or COARSE | FINE Crepitus | 21 Knees |
| Passive Flexion for Standard Knee Device at 12-months | Patellar Crepitus Defined as No Crepitus, FINE or COARSE | NO Crepitus | 44 Knees |
| Passive Flexion for Standard Knee Device at 12-months | Patellar Crepitus Defined as No Crepitus, FINE or COARSE | COARSE Crepitus | 9 Knees |
| Passive Flexion for High Flexion Knee Device at Pre-op | Patellar Crepitus Defined as No Crepitus, FINE or COARSE | FINE Crepitus | 29 Knees |
| Passive Flexion for High Flexion Knee Device at Pre-op | Patellar Crepitus Defined as No Crepitus, FINE or COARSE | NO Crepitus | 41 Knees |
| Passive Flexion for High Flexion Knee Device at Pre-op | Patellar Crepitus Defined as No Crepitus, FINE or COARSE | COARSE Crepitus | 5 Knees |
| Passive Flexion for High Flexion Knee Device at 6-months | Patellar Crepitus Defined as No Crepitus, FINE or COARSE | FINE Crepitus | 22 Knees |
| Passive Flexion for High Flexion Knee Device at 6-months | Patellar Crepitus Defined as No Crepitus, FINE or COARSE | NO Crepitus | 52 Knees |
| Passive Flexion for High Flexion Knee Device at 6-months | Patellar Crepitus Defined as No Crepitus, FINE or COARSE | COARSE Crepitus | 4 Knees |
| Passive Flexion for High Flexion Knee Device at 12-months | Patellar Crepitus Defined as No Crepitus, FINE or COARSE | NO Crepitus | 52 Knees |
| Passive Flexion for High Flexion Knee Device at 12-months | Patellar Crepitus Defined as No Crepitus, FINE or COARSE | COARSE Crepitus | 4 Knees |
| Passive Flexion for High Flexion Knee Device at 12-months | Patellar Crepitus Defined as No Crepitus, FINE or COARSE | FINE Crepitus | 22 Knees |
Secondary
Patient Specific Anthropometrics
Various Patient specific anthropometrics were examined to assess their potential influence and interaction on post-op outcomes.
Time frame: Collected at pre-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Passive Flexion for Standard Knee Device at Pre-op | Patient Specific Anthropometrics | 50.2 Centimeters | Standard Deviation 6.3 |
| Passive Flexion for Standard Knee Device at 6-months | Patient Specific Anthropometrics | 24.8 Centimeters | Standard Deviation 2.7 |
| Passive Flexion for Standard Knee Device at 12-months | Patient Specific Anthropometrics | 3.23 Centimeters | Standard Deviation 1.46 |
Secondary
Single Leg Active Flexion (SLAF)
Weight-bearing single leg active flexion (SLAF). A medically trained professional conducts this test using a goniometer, which is an angle-measuring device. Of note, pre-op patients have a lower number because they were unable or unwilling to participate in SLAF due to pain.
Time frame: Pre-op, 6- and 12-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Passive Flexion for Standard Knee Device at Pre-op | Single Leg Active Flexion (SLAF) | 124.6 Degrees of flexion | Standard Deviation 11.1 |
| Passive Flexion for Standard Knee Device at 6-months | Single Leg Active Flexion (SLAF) | 126.0 Degrees of flexion | Standard Deviation 11 |
| Passive Flexion for Standard Knee Device at 12-months | Single Leg Active Flexion (SLAF) | 126.6 Degrees of flexion | Standard Deviation 10.6 |
| Passive Flexion for High Flexion Knee Device at Pre-op | Single Leg Active Flexion (SLAF) | 120.9 Degrees of flexion | Standard Deviation 13.3 |
| Passive Flexion for High Flexion Knee Device at 6-months | Single Leg Active Flexion (SLAF) | 125.2 Degrees of flexion | Standard Deviation 10.8 |
| Passive Flexion for High Flexion Knee Device at 12-months | Single Leg Active Flexion (SLAF) | 127.5 Degrees of flexion | Standard Deviation 11.1 |
Secondary
Subgroup Analysis - Passive Flexion Analyzed and Reported for Pre-op, 6- and 12-months, for Subjects With Less Than 120 Degrees Passive Flexion Pre-op in Either Knee
The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device.
Time frame: Collected at Pre-operative, 2 and 6 weeks and 6- and 12-months, analyzed and reported for pre-op, 6- and 12-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Passive Flexion for Standard Knee Device at Pre-op | Subgroup Analysis - Passive Flexion Analyzed and Reported for Pre-op, 6- and 12-months, for Subjects With Less Than 120 Degrees Passive Flexion Pre-op in Either Knee | 111.6 Degrees of passive flexion | Standard Deviation 6 |
| Passive Flexion for Standard Knee Device at 6-months | Subgroup Analysis - Passive Flexion Analyzed and Reported for Pre-op, 6- and 12-months, for Subjects With Less Than 120 Degrees Passive Flexion Pre-op in Either Knee | 118.9 Degrees of passive flexion | Standard Deviation 13.9 |
| Passive Flexion for Standard Knee Device at 12-months | Subgroup Analysis - Passive Flexion Analyzed and Reported for Pre-op, 6- and 12-months, for Subjects With Less Than 120 Degrees Passive Flexion Pre-op in Either Knee | 120.2 Degrees of passive flexion | Standard Deviation 11.3 |
| Passive Flexion for High Flexion Knee Device at Pre-op | Subgroup Analysis - Passive Flexion Analyzed and Reported for Pre-op, 6- and 12-months, for Subjects With Less Than 120 Degrees Passive Flexion Pre-op in Either Knee | 111.4 Degrees of passive flexion | Standard Deviation 5.8 |
| Passive Flexion for High Flexion Knee Device at 6-months | Subgroup Analysis - Passive Flexion Analyzed and Reported for Pre-op, 6- and 12-months, for Subjects With Less Than 120 Degrees Passive Flexion Pre-op in Either Knee | 120.9 Degrees of passive flexion | Standard Deviation 12.7 |
| Passive Flexion for High Flexion Knee Device at 12-months | Subgroup Analysis - Passive Flexion Analyzed and Reported for Pre-op, 6- and 12-months, for Subjects With Less Than 120 Degrees Passive Flexion Pre-op in Either Knee | 124.7 Degrees of passive flexion | Standard Deviation 9.8 |
Secondary
Subject Satisfaction
Secondary objective to compare the pre-op goals and post-op satisfaction through the interpretation of data collected with the use of Palm technology for bilateral knee patients
Time frame: Collected pre-and post-op, reported at 12-months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Passive Flexion for Standard Knee Device at Pre-op | Subject Satisfaction | 84 Participants |