A Comparative Study of Knee Systems

Study Overview
=================
Brief Summary
-----------------
The custom cutting guides personalized for each patient via pre-operative MRI will result in significantly faster intraoperative time with comparable knee alignment accuracy, cost, knee function, and patient satisfaction.

Official Title
-----------------
A Comparative Study of Knee Systems Employing Personalized Computer Generated Cutting Guides for Total Knee Arthroplasty

Conditions
-----------------
Osteoarthritis of the Knee

Intervention / Treatment
-----------------
* Procedure: Total Knee Arthroplasty with Custom Cutting Blocks
* Procedure: Total Knee Arthroplasty via Computer Assisted Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must be scheduled to undergo TKA with no bilateral TKA planned within 6 weeks of the initial surgery date must be 18 years of age or older must be capable and willing to provide informed consent must have flexion contracture less than 15 degrees. must have ligament stability no more than 2 degrees instability in varus/valgus extension stress Exclusion Criteria: medical condition or personal circumstances that will prevent participation and completion of the follow-up visits at 3 weeks, 6 weeks and 3 months post-op currently participating in or has participated in (within 30 days prior to inclusion in this study) another clinical trial of an investigational drug, biologic, device, or procedure known pre-operative systemic infections, uncontrolled diabetes, or diseases or conditions that are known to interfere with the wound healing process Knee alignment deformities greater than 7 degrees varus or valgus known prior knee revisions or previous surgeries deemed to compromise the TKA incision exposure known medical conditions prohibiting the use of MRI or nickel allergy, sensitivity, or hardware in the region of the knee

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

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Custom Cutting Blocks<br> | Procedure: Total Knee Arthroplasty with Custom Cutting Blocks<br>* Subjects randomized to this study group will undergo TKA with patient specific custom cutting blocks generated by pre-op MRI and a Biomet Vanguard knee implant<br>* Other names: Signature Knee System;|
| Active Comparator: Computer Assisted Surgery<br> | Procedure: Total Knee Arthroplasty via Computer Assisted Surgery<br>* Subjects randomized to this study group will receive TKA via computer assisted surgery and a Biomet Vanguard knee implant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean intraoperative time | Time measured in pre-defined segments from the point that the patient is wheeled into the OR until the OR is clean and ready for the next case's activities to begin. | measured during surgery (day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| alignment accuracy |  | 3 weeks post-op | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
total joint replacement, knee