RESUMEN
PURPOSE: 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. CONCLUSIONS: 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).
RESUMEN
OBJECTIVE: Treatment of tricompartimental osteoarthritis (OA) using customized instruments and implants for cruciate-retaining total knee arthroplasty. Use of patient-specific instruments and implants (ConforMIS iTotalTM CR G2) together with a 3D-planning protocol (iView®). Retropatellar resurfacing is optional. INDICATIONS: Symptomatic tricompartmental OA of the knee (Kellgren-Lawrence stage IV) with preserved posterior cruciate ligament (PCL) after unsuccessful conservative or joint-preserving surgical treatment. CONTRAINDICATIONS: Knee ligament instabilities of the posterior cruciate or collateral ligaments. Infection. Relative contraindication: knee deformities >15° (varus, valgus, flexion); prior partial knee replacement. SURGICAL TECHNIQUE: Midline or parapatellar medial skin incision, medial arthrotomy; distal femoral resection with patient-specific cutting block; tibial resection using either a cutting jig for the anatomic slope or a fixed 5° slope. Balancing the knee in extension and flexion gap using patient-specific spacer. The final tibial preparation achieved with gap-balanced placement of the femoral cutting jigs. Kinematic testing using anatomic trial components. Final implant components are cemented in extension. Wound layers are sutured. Drainage is optional. POSTOPERATIVE MANAGEMENT: Sterile wound dressing; compressive bandage. No limitation of the active and passive range of motion. Optional partial weight bearing during the first 2 weeks, then transition to full weight bearing. Follow-up directly after surgery, at 12 and 52 weeks, then every 1-2 years. RESULTS: Overall 60 patients with tricompartmental knee OA and preserved PCL were treated. Mean age was 66 (range 45-76) years. Minimum follow-up was 12 months. There was 1 septic revision after a low-grade infection, 1 reoperation to replace the patellar due to patellar osteoarthritis and 3 manipulations under anesthesia (MUAs) to increase range of motion. Radiographic analyses demonstrated an ideal implant fit with less than 2 mm subsidence or overhang. The WOMAC score improved from 154.8 points preoperatively to 83.5 points at 1 year and 59.3 points at 2 years postoperatively. The EuroQol-5D Score also improved from 11.1 points preoperatively to 7.7 points at 1 year postoperatively.
