Individually Customized Total Knee Replacement
DID YOU KNOW: 1 in 5 patients are not satisfied with the results of their total knee replacement surgery.i
Two of the leading causes of dissatisfaction after surgery are residual pain and functional limitations. We think both of these issues can be addressed by a better implant design.
iTotal CR is designed to achieve unique advantages as compared to off-the-shelf knee implants.
When it comes to fit, close isn’t good enough:
- If the implant extends over the bone by as few as 3mm, that can be a significant cause of pain after surgery. Unfortunately, that’s all too common. One study that involved 437 patients found that overhang ≥3mm affects 40% of men and 68% of women.ii
- iTotal CR femoral and tibial implants are designed provide a customized fit specific to your knee, helping reduce sizing compromises that can lead to long-term pain after surgery
- The tibial tray is designed to proper rotation based on the pre-operative CT scan, limiting the potential for rotational errors.
Shape drives function
- The shape of your knee plays an important role in how you bend and extend your knee
- iTotal CR is designed to mimic the natural shape of your knee, which gives your knee the potential to feel and move more naturally
Designed for optimal bone preservation.
- The average total of all bone resection measurements for iTotal CR was 27% less than the average total for surgeries done using an off-the-shelf implant.iii
Simplified surgical technique
- Patient data enables a reproducible surgical technique using pre-navigated, disposable iJig instrumentation.
- iView surgical planning images provide detailed resection values that can be used to verify accuracy throughout the surgery.
Improved operating room efficiencies
- iTotal CR is delivered in a single, pre-sterilized kit in advance of before surgery, which means limited implant inventory for the hospital
- Pre-sterilized, disposable instruments and a single reusable instrument tray mean easy set up and tear down
The result is a knee replacement that reduces sizing compromises common to off-the-shelf knee replacements.
Surgeons: 10 Things To Know
Not all patient-specific systems are created equal
The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. Only a licensed physician can help you determine the appropriate medical treatment. There are potential risks to knee replacement surgery, and individual results may vary. Before making any decisions concerning medical treatment, consult your physician regarding your options and the risks of those options. The longevity, performance and feel of any knee implant will depend on various factors, including your physical condition, your activity level, adherence to your physician’s instructions, and other factors.
The Indications for Use include:
- 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, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
- Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The implant is intended for cemented use only.
Caution: Federal law restricts this device to sale by or on the order of a physician.
i: According to a study of 1,703 patients published by Bourne in 2009 in the peer-reviewed journal Clinical Orthopaedics and Related Research (In this study entitled Patient Satisfaction after Total Knee Arthroplasty: Who is Satisfied and Who is Not?, “the overall satisfaction question was used to determine a two category satisfaction outcome by combining patients who answered very dissatisfied, dissatisfied, or neutral into one group, and patients who answered satisfied or very satisfied into the second group.”)Bourne, R.B., et al; Patient Satisfaction after Total Knee Arthroplasty. Who is Satisfied and who is not? Clinical Orthopaedics and Related Research: 2010.
ii: Mahoney, et al; Overhang of the Femoral Component in Total Knee Arthroplasty: Risk Factors and Clinical Consequences. The Journal of Bone and Joint Surgery; 2010, 92: 1115-1121
iii: In a study by W. Kurtz titled “Patient-Specific Knee Replacement Implants Preserve Bone and Decrease Blood Loss & Swelling” presented at the 2013 BASK Annual Meeting, comparing 66 iTotal patients with 66 patients receiving one off-the-shelf implant brand (Zimmer NexGen), thickness of the femoral (distal and posterior medial/lateral), and tibial (medial/lateral) resections were measured intra-operatively. The average total of all bone resection measurements for iTotal was 27% (14mm) less than for the off-the-shelf total knee. Additionally, the total thickness of the iTotal implants was 25% (15.7mm) thinner on average than the off-the-shelf implants.