Multi-Center Study to Evaluate the ConforMIS iUni Knee Implant

Study Overview
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Brief Summary
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Study is prospective and multi-center. Study will include 100 to 200 patients across up to 20 sites.The study sites will be located in the United States.The study objective is to evaluate the safety and performance of the ConforMIS iUni® Unicompartmental Knee Resurfacing Device in patients with single compartment osteoarthritis.

Detailed Description
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The iUni G2 Unicompartmental Resurfacing Device (iUni) is an FDA cleared and CE Marked implant designed for patients with damage isolated to either the medial or lateral tibiofemoral compartment of the knee. The study subjects will be followed for 10 years post implant. The study objective is to evaluate the safety and performance of the ConforMIS iUni® Unicompartmental Knee Resurfacing Device in patients with single compartment osteoarthritis. The iUni is a patient-specific unicompartmental resurfacing device designed from the patient's unique anatomy using proprietary software which interprets data from the patient's CT scan. The patient matched implant design is then coupled with unique patient-matched disposable instrumentation designed using the same CT data and software. The follow-up visit schedule will include visits at 6 weeks, 6 months (optional), 1 year, 2 years, 5 years and 10 years post implant.The remaining follow-up data collected at years 3, 4, 6, 7, 8, and 9 may be collected via phone call/email and does not require a subject visit to the site.The study sites will be located in the United States.

Official Title
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A Prospective, Multi-Center Study to Evaluate the ConforMIS iUni® G2 Unicompartmental Knee Resurfacing Device

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: iUni® Unicompartmental Knee Resurfacing Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical condition included in the approved Indications For Use Unicompartmental osteoarthritis of the medial or lateral tibiofemoral compartment Willingness to participate in the clinical study, to give informed consent and to attend all follow-up visits > 18 years of age Exclusion Criteria: Simultaneous bilateral procedure required BMI > 35 Treatment for cancer within the past 5 years, with the exception of skin cancer Poorly controlled diabetes Neuromuscular conditions which prevent patient from participating in study activities Active local or systemic infection Immunocompromised Fibromyalgia or other general body pain related condition Advanced tricompartmental osteoarthritis Symptomatic patellofemoral disease Rheumatoid arthritis or other forms of inflammatory joint disease Loss of bone or musculature, osteoporosis, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified Advanced loss of osteochondral structure on the affected femoral condyle Compromised ACL, PCL or collateral ligament Severe (>15º) fixed valgus or varus deformity Extension deficit > 15 º Prior history of failed implant surgery of the joint to be treated Unwilling or unable to comply with study requirements Participation in another clinical study which would confound results

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| open label<br>iUni® Unicompartmental Knee Resurfacing Device | Device: iUni® Unicompartmental Knee Resurfacing Device<br>* The iUni® Unicompartmental Resurfacing Device is an FDA cleared and CE Marked implant designed for patients with damage isolated to either the medial or lateral tibiofemoral compartment of the knee. The patient-specific iUni is designed from a CT scan of an individual patient's knee using a design process which interactively maps the diseased area and defines the extent of misalignment present in the knee. This process allows definition of the shape and size of the femoral and tibial components of the implant, as well as the disposable instrumentation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score | to assess knee pain and function | 2 years | 
| WOMAC Osteoarthritis Index | to assess knee pain and function | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score and WOMAC at years 5 and 10 post-implantation | Patient reported outcomes measuring pain and function | 10 years | 
| Annual revision rates at years 1 through 10 post-implantation | Number of revision rates | 10 years | 
| Incidence of major procedure-related and device-related complications | rate of incidence of serious adverse events that are related to the device or the procedure | 10 years | 
| Length of tourniquet time in minutes | how long the tourniquet was on the patient in surgery | 6 weeks | 
| Length of hospital stay in hours | How long each patient was in the hospitals from admission to discharge | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee, osteoarthritis, unicompartmental, arthroplasty, knee resurfacing, Conformis, patient specific