Abstract
Introduction
Surgical techniques for implant alignment in total knee arthroplasty (TKA) is a expanding field as manufacturers introduce patient-specific cutting blocks derived from 3D reconstructions of pre-operative imaging, commonly MRI or CT. The patient-specific OtisMed system uses a detailed MRI scan of the knee for 3D reconstruction to estimate the kinematic axis, dictating the cutting planes in the custom-fit cutting blocks machined for each patient. The resulting planned alignment can vary greatly from a neutral mechanical axis. The purpose of this study was to evaluate the early fixation of components in subjects randomized to receive shape match derived kinematic alignment or conventional alignment using computer navigation. A subset of subjects were evaluated with gait analysis.
Methods
Fifty-one patients were randomized to receive a cruciate retaining cemented total knees (Triathlon, Stryker) using computer navigation aiming for neutral mechanical axis (standard of care) or patient-specific cutting blocks (OtisMed custom-fit blocks, Stryker). Pre-operatively, all subjects had MRI scans for cutting block construction to maintain blinding. RSA exams and health outcome questionnaires were performed post-operatively at 6 week, 3, 6, and 12 month follow-ups. A subset (9 subjects) of the patient-specific group underwent gait analysis (Optotrak TM 3020, AMTI force platforms) one-year post-TKA, capturing three dimensional (3D) knee joint angles and kinematics. Principal component analysis (PCA) was applied to the 3D gait angles and moments of the patient-specific group, a case-matched control group, and 60 previously collected asymptomatic subjects.
Results
Five MRI scans for surgical planning were not useable due to motion artifacts, with 2 successfully rescanned. Ligament releases were performed in 62% of navigation cases and 32% of patient-specific cases. One patient-specific case was revised for failure of the cruciate ligament, resulting in a polyethylene liner exchange for a thicker, cruciate substituting insert. Implant migration at 1 year was 0.40±0.25 mm for the patient-specific group and 0.37±0.20 mm for the navigation group (maximum total point motions; t-test P=0.65). EQ-5D scores, Oxford Knee scores, satisfaction, pain, and range of motion were not different between groups at any follow-up to 1 year, including the polyethylene liner exchange case. The gait analysis showed that there were no statistical differences between groups. PCA captured a lower early stance phase flexion moment magnitude in the patient-specific group than the computer navigated recipients, bringing patterns further away from asymptomatic characteristics (flexion moment PC2, P=0.02).
Conclusions
Implant migration was not different between groups at 1 year despite differences in implant alignment methods. Subject function and satisfaction were also not different between groups, despite significantly fewer ligament releases in the patient-specific group. However, gait analysis of a subgroup has not shown an improvement towards restoring asymptotic gait. It should be acknowledged that the production of patient-specific cutting blocks may not be possible for all patients due to the MRI scanning requirements. Continued evaluation with RSA to 2 years will be performed to monitor these subjects over the longer term.
