Abstract
PURPOSE: To evaluate the accuracy and reproducibility of a patient-specific, customized individually made (CIM) total knee replacement (TKR) using the ORIGIN® prosthesis. METHODS: This was a prospective study conducted at a University Hospital from January 15, 2019, to April 30, 2021. The study included patients planned for an ORIGIN® CIM TKR procedure. Exclusion criteria included revision surgery, severe deformity, stiffness, or laxity. Evaluations were carried out using computed tomography scans performed 8 weeks preoperatively and 6 weeks postoperatively. The primary outcome measurements were the preoperative, planned, and postoperative CT scan alignment measurements including the Hip-Knee-Ankle (HKA) angle, mechanical Medial Distal Femoral articular surface Angle (mMDFA, distal alpha angle), Posterior Distal femoral articular surface angle (PDFA, posterior alpha angle), mechanical Medial Proximal Tibial articular surface Angle (mMPTA, beta angle) and posterior proximal tibial angle (PPTA). Secondary outcomes included the accuracy of implant positioning with percentage of outliers at 2° and 3° RESULTS: The study encompassed 51 knees from 50 patients with mean age of 68.1 (SD = 8.89). The overall HKA angle deviated by -0.93° [95% CI: -1.45; -0.43], and the PDFA angle by -0.61° [95% CI: -1.07; -0.15], while the mMPTA exceeded planned values by 1.00° [95% CI: 0.57; 1.43]. The 3° outliers rate ranged from 3.9% for the mMPTA to 7.8% for the HKA alignment, with no outliers in mMDFA and PPTA. Similarly, the 2° outliers rate ranged from 15.7% for both the PDFA angle and mMPTA to 19.6% for the HKA alignment. The Bland-Altman plots further emphasized the precision of planned and post-operative angles across all measurements. CONCLUSION: The CIM TKR showed high accuracy and reproducibility, closely matching preoperative planning. The weakest accuracy at 3°-outliers is in the reproduction of the HKA alignment at 92.2% (range for all angle: 92.2-100%). Similarly, the weakest accuracy at 2°-outliers is in the reproduction of the HKA alignment at 80.4% (range for all angles: 80.4-92.2%).