A Prospective Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System

Study Overview
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Brief Summary
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This is a prospective clinical study designed to observe the long-term clinical outcomes of total knee arthroplasty using a patient-specific, posterior stabilized implant in patients with osteoarthritis.

Detailed Description
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The study is prospective. Subjects will be implanted with an iTotal® PS Knee Replacement System. The study will include a minimum of 100 subjects across up to 10 sites. The patients enrolled in this study may represent the first cases of the iTotal PS KRS implanted at a particular site; data collected for the first 15 patients at each site will be analyzed separately from the rest of the enrolled population. This will provide visibility towards determining if there exists a learning curve in the implantation process of the iTotal PS KRS. The study sites will be located in the United States.

Official Title
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A Prospective Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: iTotal PS 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® PS 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) 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: iTotal PS KRS|Total knee arthroplasty for treatment of osteoarthritis|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline from 1-Year in KSS | Change in Knee Society Scores from the pre-operative visit to the 1-year post-operative visit. The Knee Society Score (KSS) includes an Objective Knee Score, Function Score, Satisfaction Score, and Expectation Score. The objective knee score, completed by the surgeon, includes a VAS score of pain walking on level ground and on stairs or inclines, as well as an assessment of alignment, ligament stability, and ROM, along with deductions for flexion contracture or extensor lag. Patients then record their satisfaction, functional activities, and expectations (Scuderi et al., 2012). | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in KSS at years 2, 5 and 10 post-implantation | The Knee Society Score includes an Objective Knee Score, Function Score, Satisfaction Score, and Expectation Score. The Knee Society Score (KSS) includes an Objective Knee Score, Function Score, Satisfaction Score, and Expectation Score. The objective knee score, completed by the surgeon, includes a VAS score of pain walking on level ground and on stairs or inclines, as well as an assessment of alignment, ligament stability, and ROM, along with deductions for flexion contracture or extensor lag. Patients then record their satisfaction, functional activities, and expectations (Scuderi et al., 2012). | Up to 10 years | 
| Change from baseline in KOOS at years 1, 2, 5 and 10 post-implantation | The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42 question knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. | Up to 10 years | 
| Post-operative limb alignment if long leg x-rays available | Comparison of limb alignment between pre-operative and post-operative x-rays. | 2 years | 
| Length of hospital stay in hours | How long the patient is in the hospital from the time of admission to the time of discharge. | 1 year | 
| Blood loss during surgery | Estimated blood loss during surgery (mL) | 1 year | 
| Transfusion rate | Rate of patients who require blood transfusions during surgery | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, patient-specific, knee replacement, TKA, knee arthroplasty, total knee replacement, posterior stabilized