Study of the ConforMIS iDuo(R) G2

Study Overview
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Brief Summary
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To evaluate the ConforMIS iDuo G2 implant

Detailed Description
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This is a prospective, multicenter study. The investigators will be evaluating the ConforMIS iDuo G2 implant.

Official Title
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A Prospective, Multicenter Study of the ConforMIS iDuo(R) G2 Bicompartmental Knee Repair System

Conditions
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Bicompartmental Osteoarthritis

Intervention / Treatment
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* Device: iDuo G2


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 iDuo® G2 Bicompartmental osteoarthritis defined as Medial and patellofemoral osteoarthritis, or Lateral and patellofemoral arthritis as confirmed by the investigator's assessment of disease status at screening visit. Disease status is assessed by Clinical and Radiographic assessment. In addition, CT arthrogram assessment may be utilized for diagnosis. Willingness to participate in the clinical study, to give informed consent and to attend all follow-up visits > 18 years of age Exclusion Criteria: 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 to an extent that the procedure is unjustified Diagnosed 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 Compromised ACL, PCL or collateral ligament Severe fixed valgus or varus deformity of >15º Extensor lag > 15 º Fixed flexion contracture ≥ 10 º Prior history of failed implant surgery of the joint to be treated, including high tibial osteotomy (HTO) Unwilling or unable to comply with study requirements Participation in another clinical study which would confound results If during intra-op, it is noted that the patient has tri-compartmental disease, then the patient is considered a screen fail

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 |
| --- | --- |
| iDuo G2<br>iDuo G2 to be implanted in the patient. | Device: iDuo G2<br>* single comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and function | By using questionnaires, we will look at pain and function scores at this time point | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and function at follow up time points | By using questionnaires, we will look at pain and function scores at these time points | 1, 2, 5 and 10 years post implant | 
| Revision rates | Capture revision rates | Patient will be observed for 10 years post implant | 
| Incidence of major procedure related and device related complications | To capture any procedure or device related complications | Patient will be observed for 10 years post implant | 
| Post operative limb alignment |  | X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups | 
| Radiographic implant position |  | X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups | 
| Radiographic loosening, radiolucencies |  | X rays will be taken at 1 year, 2 year, 5 year and 10 year follow ups | 
| Length of procedure | Timing from skin to cement | Day of surgery | 
| Length of hospital stay | measure length of stay from admission to discharge | Patient will be followed from admission to discharge with an average of about 5 days | 
| Blood loss during surgery |  | Day of surgery | 
| Intraoperative blood replacement volume |  | Day of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee, osteoarthritis, bicompartmental, arthroplasty, joint diseases