Clinical studies have demonstrated that these compromises on fit can cause residual pain after surgery. At ConforMIS we design partial and total knee implants to fit the patient, not the other way around. We combine proven elements of standard knee replacement with our iFit Image-to-Implant® technology to create customized knee implants and surgical instrumentation that are designed to fit your knee’s natural shape and curves.
With this patient-specific approach the ConforMIS knee replacement systems offer unique advantages we believe are not possible with traditional, off-the-shelf implants, including:
- Individualized fit that reduces sizing compromises common with off-the-shelf implants and associated with residual pain after surgeryii
- Designed to follow the shape and contour of each patient’s knee, which provides an increased potential for a more natural feeling knee
- Designed for optimal bone preservationiii
- Reproducible surgical technique using disposable pre-navigated iJig® instrumentation and iView surgical planning images with detailed resection values that can be used to verify accuracy throughout the surgery
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.
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.”)
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.