This article describes the rationale and the surgical technique of patient-specific uni-, bi-, or three-compartmental knee arthroplasty using the second generation (G2) of ConforMIS™ technology. The patient-individual implants and instruments are designed and fabricated based on data from a preoperative computed tomography of the lower limb. The disposable patient-specific drill guides and cutting-jigs are manufactured under consideration of the anatomical and biomechanical axes of the knee joint and mediate efficient pre-navigation of the saw-cuts on the femoral and tibial bone without the need for an additional navigation or balancing device. The surgical technique for all types of knee resurfacement comprises the steps of cartilage removal, knee balancing in extension and flexion, sparing bony cuts, final preparation of femur and tibia, trialling, cementing of components and final choice of tibial insert. The use of individualized three-dimensional image-derived resurfacing implants, as well as personalized single-use instrumentation, facilitates the surgeon to perform an almost anatomical knee resurfacement that has the potential to restore almost normal knee kinematics. The limited data on this novel technology is promising, however long-term clinical data is needed for final evaluation of this technology.
To treat patients with tricompartimental knee osteoarthritis (OA), a customized cruciate-retaining total knee arthroplasty (CCR-TKA) system can be used, including both individualized instrumentation and implants. The objective of this monocentric cohort study was to analyze patient-reported and functional outcomes in a series of patients implanted with the second generation of this customized implant. Methods: At our arthroplasty center, we prospectively recruited a cohort of patients with tricompartmental gonarthrosis to be treated with total knee replacement (TKA) using a customized cruciate-retaining (CCR) implant design. Inclusion criteria for patients comprised the presence of intact posterior cruciate and collateral ligaments and a knee deformity that was restricted to <15° varus, valgus, or flexion contracture. Patients were assessed for their range of motion (ROM), Knee Society Score (KSS), Western Ontario and McMaster University osteoarthritis index (WOMAC), and short form (SF)-12 physical and mental scores, preoperatively, at 3 and 6 months, as well as at 1, 2, 3, and 5 years of follow-up (FU) postoperatively. Results: The average age of the patient population was 64 years (range: 40–81), the average BMI was 31 (range: 23–42), and in total, 28 female and 45 male patients were included. Implant survivorship was 97.5% (one septic loosening) at an average follow-up of 2.5 years. The KSS knee and function scores improved significantly (p < 0.001) from, respectively, 41 and 53 at the pre-operative visit, to 92 and 86, respectively, at the 5-year post-operative time point. The SF-12 Physical and Mental scores significantly (p < 0.001) improved from the pre-operative values of 28 and 50, to 50 and 53 at the 5-year FU, respectively. Patients experienced significant improvements in their overall knee range of motion, from 106° at the preoperative visit to 122°, on average, 5 years postoperatively. The total WOMAC score significantly (p < 0.001) improved from 49.1 preoperatively to 11.4 postoperatively at 5-year FU. Conclusion: Although there was no comparison to other implants within this study, patients reported high overall satisfaction and improvement in functional outcomes within the first year from surgery, which continued over the following years. These mid-term results are excellent compared with those reported in the current literature. Comparative long-term studies with this device are needed. Level of evidence 3b (individual case–control study).
In all, 31 patients with medial OA (27 medial knee osteoarthritis, 4 osteonecrosis) were treated. Mean age 60 years. Minimum follow-up 17 months. One aseptic loosening needed exchange; one acute late-onset infection with consecutive implant removal. No further revisions/reoperations or complications. X-rays showed an ideal fit of the implant with less than 2 mm subsidence or overhang in all cases. Clinically the VAS changed from 6.51 preoperatively to 1.11 postoperatively. The mean KSS (Knee Society Score) improved from 111.23 preoperatively to 180.61 postoperatively; the functional part of KSS improved from mean 60.39 to 94.51.
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