Abstract
Introduction
The effectiveness of patient specific instrumentation (PSI) to perform total knee arthroplasty (TKA) remains controversial. Multiple studies have been published that reveal conflicting results on the effectiveness of PSI, but no study has analyzed the contact kinematics within knee joints replaced with the use of PSI. Since a departure from normal kinematics can lead to eccentric loading, premature wear, and component loosening, studying the kinematics in patients who have undergone TKA with PSI can provide valuable insight on the ability of PSI to improve functionality and increase longevity. The goal of the present study was to compare femoral and tibial component migration (predictive of long-term loosening and revision) and contact kinematics following TKA using conventional instruments (CI) and PSI based surgical techniques.
Methods
The study was designed as a prospective, randomized controlled trial of 50 patients, with 25 patients each in the PSI and CI groups, powered for radiostereometric analysis (RSA). Patients in the PSI group received an MRI and standing 3-foot x-rays to construct patient-specific cut-through surgical guides for the femur and tibia with a mechanical limb alignment. All patients received the same posterior-stabilized implant with marker beads inserted in the bone around the implants to enable RSA imaging. Patients underwent supine RSA exams at multiple time points (two and six weeks, three and six months, and one and two years). At 2 years post-op, a series of RSA radiographs were acquired at different knee flexion angles, ranging in 20° increments from 0° to 120°, to measure the tibiofemoral contact kinematics. Migrations of the femoral and tibial components were calculated using model-based RSA software. Kinematics were measured for each condyle for magnitude of excursion, contact location, and stability.
Results
There were no differences (p > 0.05) between the PSI and CI groups for demographics or pre- and post-operative patient reported outcome scores. Three patients in the PSI group and seven patients in the CI group (p = 0.28) had a post-operative limb alignment outside of the neutral target (>3° varus or valgus). There was no difference in the change of tibial slope from pre- to post-operation between groups (p = 0.49). There were no differences (p > 0.05) in translations or rotations in any individual plane across all time points for either the tibial or femoral components. Maximum total point motion (MTPM) at 6 months for the tibial component was 0.54 ± 0.25 mm in the CI group and 0.51 ± 0.22 mm in the PSI group (p = 0.77), placing both groups at the low end of the “at risk” category for predicted loosening. Change in MTPM from 6 months to 1 year and again from 1 year to 2 years was <0.2 mm, indicating both groups of implants had stable fixation. Femoral component MTPM was also not different (p > 0.05) between groups. There was no significant difference between PSI and CI groups with respect to magnitude of excursion on both medial (p = 0.54) and lateral (p = 0.81) condyles. There was also no difference in contact locations on both the medial and lateral condyles (p = 0.28 to 0.91) for all angles of flexion. There was no significant difference present between PSI and CI groups when comparing the stability for both the medial (p = 0.06) and lateral (= 0.85) condyles. Condylar separation was present in 3/20 CI patients and 0/16 PSI patients (p = 0.24).
Conclusion
Using the latest RSA criteria for predicting failure from early migration, the use of PSI does not provide an advantage over CI for preventing aseptic loosening. Moreover, PSI did not provide any substantial advantage over CI for TKA surgery with respect to contact kinematics.
