An interventional study of Total knee replacement using the PFC Sigma RPF knee implant. and Total knee replacement using the PFC Sigma RP knee implant in Non-inflammatory Arthritis, sponsored by DePuy Orthopaedics. Completed at 4 sites in United States. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-07-24.
Sponsored by DePuy Orthopaedics (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment
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.
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.
DePuy Orthopaedics is the lead sponsor of 45 studies on the registry; 2 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
First submitted after DePuy Orthopaedics became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
PFC® Sigma™ RP-F knee implant is a posterior stabilized cemented component cemented that is implanted with a standard posterior stabilized surgical technique.
Device: Total knee replacement using the PFC Sigma RPF knee implant.
P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a special insert that helps the knee move more like it did before the knee replacement.
Device: Total knee replacement using the PFC Sigma RP knee implant
Total knee replacement
Total knee replacement
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
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
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
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
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
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
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
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
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
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.
| Milestone | PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement | PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement |
|---|---|---|
| Started | 93 | 91 |
| Completed | 75 | 74 |
| Not completed | 18 | 17 |
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.
| Degrees of passive flexion | Passive Flexion for Standard Knee Device at Pre-op | Passive Flexion for Standard Knee Device at 6-months | Passive Flexion for Standard Knee Device at 12-months | Passive Flexion for High Flexion Knee Device at Pre-op | Passive Flexion for High Flexion Knee Device at 6-months | 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 | 111.6 ± 6.0 | 118.9 ± 13.9 | 120.2 ± 11.3 | 111.4 ± 5.8 | 120.9 ± 12.7 | 124.7 ± 9.8 |
Various Patient specific anthropometrics were examined to assess their potential influence and interaction on post-op outcomes.
| Centimeters | Thigh Circumference in Centimeters (cm) | Ankle Circumference in Centimeters (cm) | Skin-fold in Centimeters (cm) |
|---|---|---|---|
| Patient Specific Anthropometrics | 50.2 ± 6.3 | 24.8 ± 2.7 | 3.23 ± 1.46 |
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.
| Units on a scale | AKS for the Standard Knee Device | AKS for the High Flexion Knee Device |
|---|---|---|
| American Knee Society (AKS) Score | 85.6 ± 11.5 | 87.0 ± 10.7 |
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.
| Units on a scale | KOOS Pain Sub-score Standard Knee Device at Pre-op | KOOS Pain Sub-score Standard Knee Device at 6-months | KOOS Pain Sub-score Standard Knee Device at 12-months | KOOS Pain Sub-score High Flexion Knee Device at Pre-op | KOOS Pain Sub-score High Flexion Knee Device at 6-months | KOOS Pain Sub-score High Flexion Knee Device at 12-months |
|---|---|---|---|---|---|---|
| KOOS Pain Sub-score | 45.7 ± 19.2 | 84.0 ± 14.8 | 89.5 ± 14.0 | 45.3 ± 18.2 | 83.1 ± 14.9 | 90.0 ± 11.8 |
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.
| Points on a scale | KOOS Sub-scale for Activity of Daily Living (ADL) for Standard Knee Device at Pre-op | KOOS Sub-scale for Activity of Daily Living for Standard Knee Device at 6-months. | KOOS Sub-scale for Activity of Daily Living for Standard Knee Device at 12-months. | KOOS Sub-scale for Activity of Daily Living for High Flexion Knee Device at Pre-op | KOOS Sub-scale for Activity of Daily Living for High Flexion Knee Device at 6-months | KOOS Sub-scale for Activity of Daily Living for High Flexion Knee Device at 12-months |
|---|---|---|---|---|---|---|
| Ability to Perform Activities of Daily Living (ADLs) as Per the KOOS Sub-scale for ADLs | 49.0 ± 20.2 | 85.4 ± 14.0 | 90.4 ± 11.8 | 47.9 ± 19.2 | 85.6 ± 12.7 | 90.1 ± 11.3 |
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.
| Knees | Patellar Crepitus in Standard (RP) Flexion Cohort at Pre-Op | Patellar Crepitus in High Flexion Cohort (RPF) at Pre-op | Patellar Crepitus in Standard Flexion (RP) Cohort at 6-months | Patellar Crepitus in High Flexion (RPF) Cohort at 6 Months | Patellar Crepitus in Standard Flexion (RP) Cohort at 12-months | Patellar Crepitus in High Flexion (RPF) Cohort at 12-months |
|---|---|---|---|---|---|---|
| NO Crepitus | 15 | 13 | 44 | 41 | 52 | 52 |
| FINE Crepitus | 31 | 37 | 21 | 29 | 22 | 22 |
| COARSE Crepitus | 45 | 42 | 9 | 5 | 4 | 4 |
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
| Participants | All Bilateral Patients Reporting Satisfaction at 12-months After Knee Replacement |
|---|---|
| Subject Satisfaction | 84 |
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.
| Degrees of passive flexion | PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement | PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement |
|---|---|---|
| Knee Society Passive Flexion at 6 Months | 124.2 ± 11.2 | 124.0 ± 10.6 |
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.
| Degrees of flexion | Single Leg Active Flexsion (SLAF) for the Standard Knee Device at Pre-op | Single Leg Active Flexion (SLAF) for Standard Knee Device at 6-months | Single Leg Active Flexion (SLAF) for Standard Knee Device at 12-months | Single Leg Active Flexion (SLAF) High Flexion Knee Device at Pre-op | Single Leg Active Flexion (SLAF) for the High Flexion Knee Device at 6-months | Single Leg Active Flexion (SLAF) for the High Flexion Knee Device at 12-months |
|---|---|---|---|---|---|---|
| Single Leg Active Flexion (SLAF) | 124.6 ± 11.1 | 126.0 ± 11.0 | 126.6 ± 10.6 | 120.9 ± 13.3 | 125.2 ± 10.8 | 127.5 ± 11.1 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement | — | 3/93 (3.2%) | 10/93 (10.8%) |
| PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement | — | 2/91 (2.2%) | 8/91 (8.8%) |
| Event | PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement | PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement |
|---|---|---|
| InfectionInfections and infestations | 1/93 | 1/91 |
| LooseningInjury, poisoning and procedural complications | 1/93 | 1/91 |
| Polyethylene FailureInjury, poisoning and procedural complications | 1/93 | 0/91 |
| Event | PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement | PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement |
|---|---|---|
| RespiratoryRespiratory, thoracic and mediastinal disorders | 8/93 | 8/91 |
| MusculoskeletalMusculoskeletal and connective tissue disorders | 5/93 | 4/91 |
| Age, Continuous(years) | PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement | PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement | Total |
|---|---|---|---|
| Mean | 61.4 ± 5.6 | 61.4 ± 5.7 | 61.4 ± 5.8 |
| Sex: Female, Male(knees) | PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement | PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement | Total |
|---|---|---|---|
| Female | 61 | 60 | 121 |
| Male | 32 | 31 | 63 |
| Region of Enrollment(knees) | PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement | PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement | Total |
|---|---|---|---|
| United States — United States | 93 | 91 | 184 |
Ran from Mar 2006 to primary completion in Dec 2009, 45 months.
Results were first posted in Apr 2011, 1 year 4 months after primary completion.
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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