LEGION™ Revision Metal Hypersensitivity Study

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized, multi-center, metal hypersensitivity study comparing OXINIUM and cobalt chrome femoral components in subjects with failed total knee arthroplasty (TKA).

Detailed Description
-----------------
A total of 230 subjects will be randomized (1:1) to receive either an OXINIUM or cobalt chrome femoral components as part of their LEGION revision procedure. The objective of this study is to assess a lower serum metal ion concentration level in at least one of the three major mLTTs (Co, Cr or Ni) over 5 years in subjects receiving OXINIUM versus Cobalt Chrome femoral components as part of the LEGION Revision Total Knee System.

Official Title
-----------------
A Prospective, Randomized, Multi-Center, Metal Hypersensitivity Study Comparing OXINIUM and Cobalt Chrome Femoral Components in Failed Total Knee Arthroplasty

Conditions
-----------------
Total Knee Replacement Revision

Intervention / Treatment
-----------------
* Device: LEGION OXINIUM
* Device: LEGION Cobalt Chrome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is skeletally mature Subject is willing to sign and date an IRB/EC approved consent form Subject is a candidate for a revision knee replacement Subject has met an acceptable preoperative medical clearance and is free or treated for cardiac, pulmonary, hematological, infection, or other conditions that would pose excessive operative risk Subject agrees to adhere to the 10-year study visit schedule Exclusion Criteria: Subject with a known metal hypersensitivity Subject requires a known bilateral revision TKA Subject has severe pronation of the ipsilateral foot or any other relevant clinical condition contributing to abnormal ambulation Subject has active infection or sepsis (treated or untreated) Subject with an immunosuppressive disorder Subject has presence of malignant tumor, metastatic, or neoplastic disease Subject has conditions that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease) Subject has had intra-articular corticosteroid therapy (or any other intra-articular therapy) in the study knee within 3 months of study enrollment Subject has inadequate bone stock to support the device and would require significant augmentation to correct the joint Female subject is of child-bearing age and unwilling to use an approved method of contraception Subject has an emotional or neurological condition that would pre-empt their ability or willingness to comply with the study Subject is severely overweight (BMI>40) Subject is currently enrolled in another investigational drug, biologic, or device study or has been treated with an investigational product in the past 30 days Subject is facing current or impending incarceration
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: LEGION OXINIUM femoral component<br> | Device: LEGION OXINIUM<br>* Investigational Group<br>|
| Active Comparator: LEGION Cobalt Chrome femoral components<br> | Device: LEGION Cobalt Chrome<br>* Control Group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major modified Lymphocyte Transformation Tests (Cobalt, Chromium and Nickel) measurements | Metal hypersensitivity will be concluded if at least one of these three measurements is statistically significant | 3,650 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor modified Lymphocyte Transformation Tests (Aluminum, Iron, Molybdenum, Vanadium and Zirconium) | changes in mean mLTTs serum concentration values from baseline to each subsequent assessment | 3,650 Days | 
| Changes in mean serum bio-markers from baseline to each subsequent assessment |  | 3,650 Days | 
| Skin lesion evaluation to measure hypersensitivity |  | 3,650 Days | 
| Revision of LEGION Revision Knee System for any reason at each post-surgical assessment |  | 3,650 Days | 
| Improves in mean 2011 Knee Society Score (2011 KSS) from baseline to each subsequent assessment |  | 3,650 Days | 
| Anteroposterior, lateral and skyline knee views are assessed by radiographs |  | 3,650 Days | 
| All adverse event reporting from surgery to 10 year post-surgery |  | 3,650 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypersensitivity, metal sensitivity, arthroplasty, implant-related hypersensitivity, metal-on-metal implants, knee revision