TKA Operating Room Efficiency for TKA Using Customized Implant Techniques

Study Overview
=================
Brief Summary
-----------------
This is a multi-centered prospective, consecutively enrolled study that will be conducted in the United States. Surgeons that are new users of the iTotal Knee system (defined by no experience using the customized Total Knee Replacement (TKR) in the last 6 months) will be involved in the study. To complete the study protocol, the center will collect baseline surgical and training data on 10 off-the-shelf TKR patients using the implant system the surgeon currently uses. Then the first 50 consecutive patients who have been identified to receive the iTotal implant (Cruciate-Retaining or Posterior-Stabilizing) based on patient factors and the implant system IFU will be enrolled in the study. Simultaneous bilateral Total Knee Arthroplasty cases will be excluded.

Official Title
-----------------
What Factors Affect Operating Room Efficiency When Performing TKA Using Customized Implant Techniques: Conformis iTotal (CR), (PS)

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Device: Off-the-Shelf Implant Total Knee Replacement
* Device: Customized Implant Total Knee Replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years of age Exclusion Criteria: Participation in another clinical study which would confound results Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons Simultaneous bilateral Total Knee Arthroplasty cases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Off-the-Shelf Total Knee Arthroplasty Patients<br> | Device: Off-the-Shelf Implant Total Knee Replacement<br>* Total Knee Replacement, or knee arthroplasty, is a common surgical procedure performed to relieve the pain and disability resulting from osteoarthritis. In general, the surgery consists of replacing the diseased or damaged joint surfaces of the knee with metal and plastic components shaped to allow continued motion of the knee. Off-the-Shelf implants use standard sizing.<br>|
| Conformis iTotal Total Knee Arthroplasty Patients<br> | Device: Customized Implant Total Knee Replacement<br>* Total Knee Replacement, or knee arthroplasty, is a common surgical procedure performed to relieve the pain and disability resulting from osteoarthritis. In general, the surgery consists of replacing the diseased or damaged joint surfaces of the knee with metal and plastic components shaped to allow continued motion of the knee. Customized implants are customized individually made knee implants which are designed specific to each patient's unique anatomy.<br>* Other names: Conformis iTotal;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating Room Efficiency | Surgeon questionnaire to determine operating room efficiency from the 1st to the 50th iTotal implant performed and to determine any differences that might exist between operating room efficiency between the iTotal surgery and baseline metrics when performing OTS implant surgery | Single time point - day of surgery |