A Clinical Investigation of the Vanguard™ Complete Knee System

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard™ Complete Knee System.

Detailed Description
-----------------
This is a 10-year prospective observational data collection on the Vanguard Total Knee system. Patients are asked to come in for a preop, operative, immediate post-operative, 6 Month, 1 Year, 3 Year,5 Year, 7 year, and 10 year visits to check on the function, range of motion, and radiographic assessment of their total knee device. The Vanguard Knee is an FDA cleared device, and has been on the market since 2004.

Official Title
-----------------
A Prospective, Non-controlled, Clinical Investigation of the Vanguard™ Complete Knee System

Conditions
-----------------
Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis, Lower Limb Deformity, Complications, Arthroplasty

Intervention / Treatment
-----------------
* Device: Vanguard™ Complete Knee System
* Device: Vanguard™ Patient-Specific Femur


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. Correction of varus, valgus, or posttraumatic deformity Correction or revision of unsuccessful osteotomy, or arthrodesis Patient selection factors to be considered include: Need to obtain pain relief and improve function Ability and willingness of the patient to follow instructions Including control of weight and activity level Good nutritional state of the patient Patient must have reached full skeletal maturity Exclusion criteria: Absolute contraindications include: Infection Sepsis Osteomyelitis Failure of a previous joint replacement Relative contraindications include: Uncooperative patient or patient with neurologic disorders who are incapable of following directions Osteoporosis Metabolic disorders which may impair bone formation Osteomalacia Distant foci of infections which may spread to the implant site Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram Vascular insufficiency, Muscular atrophy, Neuromuscular disease Incomplete or deficient soft tissue surrounding the knee Additional exclusion criteria includes: failure of a previous joint replacement

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vanguard™ Complete Knee System<br>Vanguard Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS) | Device: Vanguard™ Complete Knee System<br>* Primary Total Knee System, Cruciate-Retaining (CR) or Posterior-Stabilized (PS)<br>|
| Vanguard™ Patient-Specific Femur<br>Vanguard Total Knee System used in combination with Signature technique to provide a patient-specific femur | Device: Vanguard™ Patient-Specific Femur<br>* Primary Total Knee System used with Signature technique to provide a patient-specific femur<br>* Other names: Vanguard Select;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KSS | Knee Society Score Assessment | 10 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Information | Radiographic Evaluation Report | 10 years | 
| Survivorship | Knee Society Score Assessment | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total Knee Arthroplasty, Total Knee Replacement, Knee Arthritis