Patient specific instrumentation (PSI) uses advanced imaging of the knee (CT or MRI) to generate individualised cutting blocks aimed to make the procedure of total knee arthroplasty (TKA) more accurate and efficient. However, in this era of healthcare cost consciousness, the value of new technologies needs to be critically evaluated. There have been several comparative studies looking at PSI versus standard instrumentation. Most compare PSI with conventional instrumentation in terms of alignment in the coronal plane, operative time and surgical efficiency, cost effectiveness and short-term outcomes. Several systematic reviews and meta-analyses have also been published. PSI has not been shown to be superior compared with conventional instrumentation in its ability to restore traditional mechanical alignment in primary TKA. Most studies show comparative efficacy and no decrease in the number of outliers in either group. In terms of operative time and efficiency, PSI tended towards decreasing operative time, saving a mean of five minutes per patient (0 to 20). Furthermore, while some cost savings could be realised with less operative time and reduced instrumentation per patient, these savings were overcome by the cost of the CT/MRI and the cutting blocks. Finally, there was no evidence that PSI positively affected clinical outcomes at two days, two months, or two years. Consequently, current evidence does not support routine use of PSI in routine primary TKA. Cite this article: Bone Joint J 2016;98-B(1 Suppl A):78–80

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

A feasibility study of the use of an MRI based patient specific knee arthroplasty system within the NHS. Introducing new technologies within a public funded health system can be challenging. We assess the use and potential benefit of customised jigs for knee arthroplasty. Outcomes assessed were safety and accuracy of implantation. Eight knee replacements using custom jigs were compared to 11 conventionally instrumented replacements matched to surgeon and operative day. Parameters measured include tourniquet time; drain output; hospital stay; adjusted change in haemoglobin; complications; and component position on post-operative long-leg alignment films. None of the parameters observed demonstrated a statistically significant difference from the conventional arthroplasty group. No complications were seen in either group. No significant differences were seen in alignment. Our early experiences show that this technology appears safe and allows accurate implantation of the prosthesis. There was a trend for decreased stay and blood loss. The health economic benefits of navigational arthroplasty have been demonstrated in other studies and come from the lack of instrumentation of the intramedullary canal. MRI based patient specific instrumentation is considered technically easier and more convenient than intra-operative navigation. A larger study is planned to assess the health economic implications of adopting this new technology

The cause of dissatisfaction following total knee arthroplasty (TKA) remains elusive. Much attention has been focused on static mechanical alignment as a basis for surgical success and optimising outcomes. More recently, research on both normal and osteoarthritic knees, as well as kinematically aligned TKAs, has suggested that other specific and dynamic factors may be more important than a generic target of 0 ± 3º of a neutral axis. Consideration of these other variables is necessary to understand ideal targets and move beyond generic results.

Cite this article: Bone Joint J 2016;98-B(1 Suppl A):81–3.

Patient specific cutting guides generated by preoperative Magnetic Resonance Imaging (MRI) of the patient’s extremity have been proposed as a method of improving the consistency of Total Knee Arthroplasty (TKA) alignment and adding efficiency to the operative procedure. The cost of this option was evaluated by quantifying the savings from decreased operative time and instrument processing costs compared to the additional cost of the MRI and the guide. Coronal plane alignment was measured in an unselected consecutive series of 200 TKAs, 100 with standard instrumentation and 100 with custom cutting guides. While the cutting guides had significantly lower total operative time and instrument processing time, the estimated $322 savings was overwhelmed by the $1,500 additional cost of the MRI and the cutting guide. All measures of coronal plane alignment were equivalent between the two groups. The data does not currently support the proposition that patient specific guides add value to TKA.

Smart trials are total knee tibial trial liners with load bearing and alignment sensors that will graphically show quantitative compartment load-bearing forces and component track patterns. These values will demonstrate asymmetrical ligament balancing and misalignments with the medial retinaculum temporarily closed. Currently surgeons use feel and visual estimation of imbalance to assess soft-tissue balancing and tracking with the medial retinaculum open, which results in lower medial compartment loads and a wider anteroposterior tibial tracking pattern. The sensor trial will aid the total knee replacement surgeon in performing soft-tissue balancing by providing quantitative visual feedback of changes in forces while performing the releases incrementally. Initial experience using a smart tibial trial is presented.