iTotal CR^® Patient-Specific Total Knee Replacement System

The ConforMIS iTotal CR (the "i" stands for individualized) is a patient-specific knee implant intended for use as a total knee replacement for patients with knee joint and disability. The iTotal is appropriate for patients whose conditions cannot be solely addressed by the use of an implant designed to treat only one or two of the three knee compartments such as a unicondylar, patello-femoral or bi-compartmental prosthesis. Together with the iUni G2 and iDuo G2, the iTotal CR provides surgeons with a range of patient-specific arthroplasty options for treatment of the knee.

iTotal CR Implant and Positioning iJig

The patient-specific process for the iTotal CR produces customized implants with unique advantages. Each iTotal CR is made to fit an individual patient precisely without the sizing compromises common with traditional systems. The ability to maximize coverage for each patient enables one of the broadest implant contact areas in the industry, resulting in extremely low polyethylene contact stress. In addition, patient-specific technology on the femur creates articulating surfaces that better match a patient's natural shape while preserving more bone than a traditional total knee replacement.

Combining proven TKR principles with the unique advantages of the ConforMIS iFit technology, ConforMIS has developed the only personalized total knee implant designed to conform precisely to the patient's own unique anatomy.

How it Works

The patient-specific iTotal CR is designed from the CT scan of an individual patient's knee using the ConforMIS iFit technology. The iFit design process interactively maps the diseased joint, using the patient-specific bone geometry to define the shape and size of the femoral and tibial components as well as the patient-specific instrumentation. That image then guides the design and manufacturing of the jigs and the personalized implants. The iTotal CR personalized implants and iJigs personalized instrumentation together are designed to restore the patients' articular surfaces.

iTotal CR Features

• No sizing compromises common with traditional non-personalized implants
• Broad implant contact areas, resulting in extremely low polyethylene contact stress
• Articulating surfaces that better match a patient's natural shape
• More bone preservation than a traditional total knee replacement
• Maximized proximal tibial coverage to reduce risk of tibial implant subsidence and loosening
• Disposable, patient-specific iJig instrumentation with built-in image guidance
• Simple, reproducible surgical technique
• Patient specific design made for each individual, based on their anatomy
• Implants that better match your natural shape

Who is a Candidate

Intended Use

• Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.
• Post traumatic loss of joint function.
• Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
• Failed osteotomies, hemiarthoplasties, and unicondylar, patello-femoral or bi-compartmental implants.

The iTotal CR implant is intended for cemented use only.

Contraindications

• Active or recent local or systemic infection.
• Insufficient bone stock on the femoral or tibial surfaces.
• Skeletal immaturity.
• Loss of bone or musculature, osteoporosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustifiable (e.g., absence of musculoligamentous supporting structures, joint neuropathy).
• Severe instability due to advanced loss of osteochondral structure or the absence of collateral ligament integrity.
• Severe (>15°) fixed valgus or varus deformity.
• Metal sensitivity (e.g., nickel).