Comparing shared decision making using a paper and digital consent process. A multi-site, single centre study in a trauma and orthopaedic department.

INTRODUCTION: The importance of shared decision making (SDM) for informed consent has been emphasised in the updated regulatory guidelines. Errors of completion, legibility and omission have been associated with paper-based consent forms. We introduced a digital consent process and compared it against a paper-based process for quality and patient reported involvement in shared decision making. METHODS: 223 patients were included in this multi-site, single centre study. Patient consent documentation was by either a paper consent form or the Concentric digital consent platform. Consent forms were assessed for errors of legibility, completion and accuracy of content. Core risks for 20 orthopaedic operations were pre-defined by a Delphi round of experts and forms analysed for omission of these risks. SDM was determined via the 'collaboRATE Top Score', a validated measure for gold-standard SDM. RESULTS: 72% (n = 78/109) of paper consent forms contained ≥1 error compared to 0% (n = 0/114) of digital forms (P < 0.0001). Core risks were unintentionally omitted in 63% (n = 68/109) of paper-forms compared to less than 2% (n = 2/114) of digital consent forms (P < 0.0001). 72% (n = 82/114) of patients giving consent digitally reported gold-standard SDM compared to 28% (n = 31/109) with paper consent (P < 0.001). CONCLUSION: Implementation of a digital consent process has been shown to reduce both error rate and the omission of core risks on consent forms whilst increasing the quality of SDM. This novel finding suggests that using digital consent can improve both the quality of informed consent and the patient experience of SDM.

Kinematic alignment of current TKA implants does not restore the native trochlear anatomy.

INTRODUCTION: Preserving constitutional patellofemoral anatomy, and thus producing physiological patellofemoral kinematics, could prevent patellofemoral complications and improve clinical outcomes after kinematically aligned TKA (KA TKA). Our study aims 1) to compare the native and prosthetic trochleae (planned or implanted), and 2) to estimate the safety of implanting a larger Persona® femoral component size matching the proximal lateral trochlea facet height (flange area) in order to reduce the native articular surfaces understuffing generated by the prosthetic KA trochlea. METHODS: Persona® femoral component 3D model was virtually kinematically aligned on 3D bone-cartilage models of healthy knees by using a conventional KA technique (group 1, 36models, planned KA TKA) or an alternative KA technique (AT KA TKA) aiming to match the proximal (flange area) lateral facet height (10 models, planned AT KA TKA). Also, 13postoperative bone-implant (KA Persona®) models were co-registered to the same coordinate geometry as their preoperative bone-cartilage models (group 2implanted KA TKA). In-house analysis software was used to compare native and prosthetic trochlea articular surfaces and medio-lateral implant overhangs for every group. RESULTS: The planned and performed prosthetic trochleae were similar and valgus oriented (6.1 and 8.5, respectively), substantially proximally understuffed compared to the native trochlea. The AT KA TKAs shows a high rate of native trochlea surface overstuffing (70%, 90%, and 100% for lateral facet, groove, medial facet) and mediolateral implant overhang (60%). There was no overstuffing with conventional KA TKAs having their anterior femoral cut flush. CONCLUSION: We found that with both the planned and implanted femoral components, the KA Persona® trochlea was more valgus oriented and understuffed compared to the native trochlear anatomy. In addition, restoring the lateral trochlea facet height by increasing the femoral component size generated a high rate of trochlea overstuffing and mediolateral implant overhang. While restoring a native trochlea with KA TKA is not possible, the clinical impact of this is low, especially on PF complications. In current practice it is better to undersize the implants even if it does not restore the native anatomy. Longer follow-up is needed for KA TKAs performed with current implant, and the debate of developing new, more anatomic, implants specifically designed for KA technique is now opened. LEVEL OF EVIDENCE: II, Laboratory controlled study.