Does Implant Design Improve Postoperative Flexion?

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does Implant Design Improve Postoperative Flexion?A Prospective, Randomized, Comparative, Multi-center Study Comparing PFC® Sigma™ RP Knee Versus PFC® Sigma™ RP-F Implanted in Simultaneous Bilateral Subjects

Conditions
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Non-inflammatory Arthritis

Intervention / Treatment
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* Device: Total knee replacement using the PFC Sigma RPF knee implant.
* Device: Total knee replacement using the PFC Sigma RP knee implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PFC Sigma RP-F<br>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.<br>* Total knee replacement<br>|
| Active Comparator: PFC Sigma RP<br>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<br>* Total knee replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Replacement, Flexion, Range of Motion, Activities of Daily Living, Implant design, Subject Satisfaction, Non-inflammatory arthritis