Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
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. |
6 months |
|
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. |
Collected at Pre-operative, 2 and 6 weeks and 6- and 12-months, analyzed and reported for pre-op, 6- and 12-months |
|
Secondary |
Patient Specific Anthropometrics |
Various Patient specific anthropometrics were examined to assess their potential influence and interaction on post-op outcomes. |
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. |
Collected Pre-operative, 2 and 6 weeks and 6 and 12 months follow up. Reporting for final 12-month interval |
|
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. |
Pre-operative, 2 and 6 weeks and 6 and 12 months and analyzed and reported for pre-op, 6- and 12-months follow up |
|
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. |
Collected at pre-operative, 2 and 6 weeks and 6 and 12 months, analyzed and reported for pre-op, 6 and 12-months |
|
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. |
Collected at Pre-operative, 6 weeks and 6 and 12 months |
|
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 |
Collected pre-and post-op, reported at 12-months |
|
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. |
Pre-op, 6- and 12-months |
|