A Multicenter Study to Evaluate Functional Outcome After Knee Replacement

Study Overview
=================
Brief Summary
-----------------
Patients will be consecutively enrolled by implant. Implant groups will be those who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system. The patient will conduct functional testing and answer questionnaires. The results will compare the ConforMIS iTotal with an Off the Shelf Knee replacement.

Detailed Description
-----------------
To compare functional and patient reported outcome data for a consecutively enrolled group of subjects who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.The person conducting the functional testing will be blinded to the device implanted. Sites will perform the off-the-shelf total knees conventional instrumentation.

Official Title
-----------------
A Prospective, Multicenter Study to Evaluate Functional Outcome After Knee Replacement

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Device: Off the Shelf Total Knee Replacement
* Device: ConforMIS iTotal Knee Replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Clinical condition included in the approved Indications For Use for the iTotal CR Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure. Disease status is assessed by Clinical and Radiographic assessment Willingness to participate in the clinical study, to give informed consent and to attend all follow-up visits > 18 years of age Exclusion: Subject will require a simultaneous bilateral procedure Other lower extremity surgery within 1 year Severe (> 15º) fixed valgus or varus deformity Severe (> 15º) extension deficit Severe instability due to advanced loss of osteochondral structure Loss of bone or musculature, osteoporosis, neuromuscular or vascular compromise in the area of the joint to be operated on to an extent that the procedure is unjustified Insufficient bone stock on the femoral or tibial surfaces Contralateral knee replacement surgery within the past 6 months BMI > 40 Active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years Poorly controlled diabetes (defined as HbA1c >7 or surgeon discretion) Immunocompromised Other physical disability affecting the hips, spine, or contralateral knee that limits function Disabling chronic pain with narcotic dependence Compromised PCL or collateral ligament Prior history of failed implant surgery of the joint to be treated, including Unicompartmental Knee Arthroplasty (UKA), or Bicompartmental Knee Arthroplasty (BKA) Prior history of failed high tibial osteotomy (HTO) 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

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ConforMIS iTotal Knee replacement<br>iTotal patient-specific knee replacement system | Device: ConforMIS iTotal Knee Replacement<br>* A knee replacement performed with patient specific implant and surgical jigs.<br>|
| Active Comparator: DePuy total knee replacement<br>Off the shelf knee replacement system | Device: Off the Shelf Total Knee Replacement<br>* A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker<br>|
| Active Comparator: Zimmer total knee replacement<br>Off the shelf knee replacement system | Device: Off the Shelf Total Knee Replacement<br>* A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker<br>|
| Active Comparator: Biomet total knee replacement<br>Off the shelf knee replacement system | Device: Off the Shelf Total Knee Replacement<br>* A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker<br>|
| Active Comparator: Smith & Nephew total knee replacement<br>Off the shelf knee replacement system | Device: Off the Shelf Total Knee Replacement<br>* A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker<br>|
| Active Comparator: Stryker total knee replacement<br>Off the shelf knee replacement system | Device: Off the Shelf Total Knee Replacement<br>* A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Testing | Comparing the functional testing differences between iTotal and off the shelf | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcome using questionnaires such as the KOOS and VAS | Measuring and comparing the differences between iTotal and off the shelf knees with patient reported outcomes. | 1 year | 
| Incidents of major procedure-related and device related complications (including revision rates) | To compare revision rates between groups | 1 year | 
| Post-operative limb alignment based using x-ray views | To compare post-operative limb alignment between two groups | 1 year | 

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