Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PFC Sigma RP-F | Active Comparator | PFC® Sigma™ RP-F knee implant is a posterior stabilized cemented component cemented that is implanted with a standard posterior stabilized surgical technique. |
|
| PFC Sigma RP | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total knee replacement using the PFC Sigma RPF knee implant. | Device | Total knee replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tammy O'Dell, EMT, CCRA, CCRC | DePuy Orthopaedics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Doug Dennis | Denver | Colorado | 80210 | United States | ||
| Heekin Orthopaedics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21123592 | Derived | Tippett SR, Mang J, Dwyer KA, Lesko J, O'Dell T. Collecting data with Palm technology: comparing preoperative expectations and postoperative satisfaction in patients undergoing total knee arthroplasty. J Bone Joint Surg Am. 2010 Dec;92 Suppl 2:59-67. doi: 10.2106/JBJS.J.00827. No abstract available. |
Not provided
Not provided
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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Subjects have a Sigma RP in one knee and a Sigma RP-F in their other knee |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Degrees of passive flexion | Collected at Pre-operative, 2 and 6 weeks and 6- and 12-months, analyzed and reported for pre-op, 6- and 12-months | Knees | Knees |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal | Musculoskeletal and connective tissue disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tammy O'Dell | DePuy Orthopaedics | 574-372-7104 | TOdell2@its.jnj.com |
Not provided
Not provided
Not provided
Not provided
Not provided
| Total knee replacement using the PFC Sigma RP knee implant | Device | Total knee replacement |
|
| 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. | 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. | 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. | 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. | 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. | 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 | 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. | Pre-op, 6- and 12-months |
| Jacksonville |
| Florida |
| 32204 |
| United States |
| University of Iowa Hospital & Clinic Dept. of Orthopaedic Surgery | Iowa City | Iowa | 01075 | United States |
| Lakewood Orthopaedic Surgeons | Lakewood | Washington | 98499 | United States |
Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
| BG002 | Total | Total of all reporting groups |
| knees |
|
| Mean |
| Standard Deviation |
| years |
| Participants |
|
| Sex: Female, Male | there were 61 females and 32 males in the study. Each participant had a Sigma RP in one knee and a Sigma RP-F in the other | Count of Units | knees | knees |
|
| Region of Enrollment | Count of Units | knees | knees |
|
Single leg passive flexion for Standard Knee Device at 6-months |
| OG002 | Passive Flexion for Standard Knee Device at 12-months | Single leg passive flexion for Standard Knee Device at 12-months |
| OG003 | Passive Flexion for High Flexion Knee Device at Pre-op | Single leg passive flexion High Flexion Knee Device at pre-op |
| OG004 | Passive Flexion for High Flexion Knee Device at 6-months | Single leg passive flexion for High Flexion Knee Device at 6-months |
| OG005 | Passive Flexion for High Flexion Knee Device at 12-months | Single leg passive flexion for High Flexion Knee Device at 12-months |
|
|
| Secondary | Patient Specific Anthropometrics | Various Patient specific anthropometrics were examined to assess their potential influence and interaction on post-op outcomes. | Posted | Mean | Standard Deviation | Centimeters | Collected at pre-op |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Units on a scale | Collected Pre-operative, 2 and 6 weeks and 6 and 12 months follow up. Reporting for final 12-month interval | Knees | Knees |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Units on a scale | Pre-operative, 2 and 6 weeks and 6 and 12 months and analyzed and reported for pre-op, 6- and 12-months follow up | Knees | Knees |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Points on a scale | Collected at pre-operative, 2 and 6 weeks and 6 and 12 months, analyzed and reported for pre-op, 6 and 12-months | Knees | Knees |
|
|
|
| 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. | 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. | Posted | Count of Units | Knees | Collected at Pre-operative, 6 weeks and 6 and 12 months | Knees | Knees |
|
|
|
| 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 | Posted | Count of Participants | Participants | Collected pre-and post-op, reported at 12-months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Degrees of passive flexion | 6 months | Knees | Knees |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Degrees of flexion | Pre-op, 6- and 12-months | knees | knees |
|
|
|
| 3 |
| 93 |
| 10 |
| 93 |
| EG001 | 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. | 2 | 91 | 8 | 91 |
| Loosening | Injury, poisoning and procedural complications |
|
| Polyethylene Failure | Injury, poisoning and procedural complications |
|
| Respiratory | Respiratory, thoracic and mediastinal disorders |
|
Not provided
| Knees |
|
| Knees |
|
| Knees |
|
| FINE Crepitus |
|
| COARSE Crepitus |
|
| knees |
|