A Prospective Study to Evaluate the iTotal Knee and iPoly XE Tibial Inserts

Study Overview
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Brief Summary
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This study is designed to evaluate the clinical outcomes of subjects who have recently undergone surgery with the iTotal® Cruciate Retaining (CR) Total Knee Replacement System (KRS) who have also had iPoly XE Tibial Inserts implanted.

Detailed Description
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The study is prospective and single-center. Subjects will be implanted with an iTotal® CR Knee Replacement System in conjunction with an iPoly XE insert. The study will include a minimum of 50 subjects and a maximum of 60 subjects at a single center. The study site will be located in Germany. The study subjects will be followed for 10 years post implant.

Official Title
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A Prospective Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System and iPoly XE Tibial Inserts

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: iPoly XE tibial insert with ConforMIS iTotal KRS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: Simultaneous bilateral procedure required 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 Neuromuscular conditions which prevent patient from participating in study activities Active local or systemic infection Immunocompromised Fibromyalgia or other general body pain related condition Rheumatoid arthritis or other forms of inflammatory joint disease Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated on, to an extent that the procedure is unjustified Diagnosed with or receiving treatment for Osteoporosis Other physical disability affecting the hips, spine, or contralateral knee Severe instability due to advanced loss of osteochondral structure Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO) Compromised PCL or collateral ligament Severe fixed valgus or varus deformity of >15º Extensor lag > 15º Fixed flexion contracture ≥ 15º Unwilling or unable to comply with study requirements Participation in another clinical study which would confound results Allergy to any of the implant materials

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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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ConforMIS iTotal Knee with iPoly Insert<br>The tibial insert being utilized in this study will be a highly-crosslinked, Vitamin-E enriched UHMWPE (iPoly XE) instead of traditional tibial inserts. | Device: iPoly XE tibial insert with ConforMIS iTotal KRS<br>* The implants are constructed to conform to the surface of the patient's femoral condyle and proximal tibia, replacing the damaged cartilage with a smooth articulating surface. The femoral component and tibial tray are manufactured from cobalt chromium molybdenum alloy. The tibial insert and patellar component are manufactured from ultra-high molecular weight polyethylene.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to 1-year in Knee Society Score | Change in Knee Society Score from baseline (12 weeks post implantation) to 1 year post implantation. The Knee Society Score consists of three components: Objective Knee Score, Function Score, and Satisfaction Score. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline score in Knee Society Score at year 2 | Change in Knee Society Score from baseline (12 weeks post implantation) to 2 year post implantation. The Knee Society Score consists of three components: Objective Knee Score, Function Score, and Satisfaction Score. | 2 years | 
| Change from baseline score in Knee Society Score at year 5 | Change in Knee Society Score from baseline (12 weeks post implantation) to 5 year post implantation. The Knee Society Score consists of three components: Objective Knee Score, Function Score, and Satisfaction Score. | 5 years | 
| Change from baseline score in Knee Society Score at year 10 | Change in Knee Society Score from baseline (12 weeks post implantation) to 10 year post implantation. The Knee Society Score consists of three components: Objective Knee Score, Function Score, and Satisfaction Score. | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee implant, osteoarthritis, patient-specific, knee osteoarthritis