In light of recent regulatory initiatives, medical devices now require additional clinical evidence to prove their safety and efficacy. At the same time, patients' own assessment of their devices' function and performance has gained in importance. The collection of these data allows for a more comprehensive picture of clinical outcomes and complications following total knee arthroplasty (TKA). These trends have led researchers to search for new methods of acquiring, interpreting and disseminating patient-reported outcome measurements (PROMs). The current study assesses the feasibility of a digital platform for collecting PROMs that was recently adapted for TKA patients. It sought to determine patient engagement, survey completion rates, and satisfaction with this platform. Eighty-two patients (mean age, 63.7 years, 59% females) scheduled for TKA were enrolled from one US and six UK sites between January 12, 2018 and April 30, 2018. Patients were supplied with a mobile application (app) that collects a variety of PROMs, including four domains based on the Patient-Reported Outcome Information System (PROMIS™): physical function, depression, pain interference and pain behavior. The platform electronically administers questionnaires using computer-adaptive tests (CATs), which reduce the burden on patients by tailoring follow-up questions to account for their previous answers. Satisfaction with the app was assessed in subset of patients who evaluated its ease-of-use (n=45), likelihood that they would recommend it to family/friends (n=35), and whether they successfully used the information it provided during their recovery (n=31). These scores were taken on a 1 to 10 (worst to best) scale. Patients demonstrated regular engagement with the platform, with 73% using the app at least once a week. Weekly engagement remained high throughout the seven-week post-operative period (Figure 1). There was a 69% completion rate of all PROMIS™ CAT surveys during the study. The four PROMIS™ CAT domains had similar survey completion rates (Figure 2). The subset of patients queried regarding their satisfaction with the app gave it favorable mean scores for ease-of-use (8.8), likelihood to recommend to a family member or friend (8.1), and their success at using its information to improve their recovery (7.4). Initial results support this digital platform's potential for successfully and efficiently collecting large volumes of PROMs. Patients reported high levels of engagement and satisfaction. For any figures or tables, please contact authors directly.
This pilot study tested the performance of a rapid assay for diagnosing prosthetic joint infection (PJI), which measures synovial fluid calprotectin from total hip and knee revision patients. A convenience series of 69 synovial fluid samples from revision patients at the Norfolk and Norwich University Hospital were collected intraoperatively (52 hips, 17 knees) and frozen. Synovial fluid calprotectin was measured retrospectively using a new commercially available lateral flow assay for PJI diagnosis (Lyfstone AS) and compared to International Consensus Meeting (ICM) 2018 criteria and clinical case review (ICM-CR) gold standards.Aims
Methods
The rate of subsidence for lumbar fusion surgery is variable from 7- 89%. Subsidance can affect the outcome of surgery by compramising alignment, foraminal height and stability. Modic changes have been shown to affect the stiffness and strength of the vertebral end plate and shown to affect both fusion rates and clinical outcome. Ongoing laboratory investigations into the material properties of the degenerate lumbar spine show modic changes affect the end plate and trabecular bone mechanics. This study aims to bridge this basic science research into clinical practice. A retrospective analysis of all patients in two tertiary spinal centres who have undergone lumbar interbody fusion with the implantation of a ‘cage’ over the past 6 years were analysed by two independent spinal surgeons. Pre-operative MRI findings were correlated with post-operative interbody cage subsidence after 1 year.Background
Methods
The peer review process for the evaluation of
manuscripts for publication needs to be better understood by the
orthopaedic community. Improving the degree of transparency surrounding
the review process and educating orthopaedic surgeons on how to
improve their manuscripts for submission will help improve both
the review procedure and resultant feedback, with an increase in
the quality of the subsequent publications. This article seeks to clarify
the peer review process and suggest simple ways in which the quality
of submissions can be improved to maximise publication success. Cite this article:
In vitro femoral studies have demonstrated the addition of hydroxyapatite (HA), to morcellised bone graft (MBG) decreases femoral prosthesis subsidence. However, with an increased risk of femoral fracture during the impaction of a MBG:HA mixture, possibly due to greater force transmission to the femoral cortex via the HA. The aim was to compare the hoop strains and subsidence of a 1:1 mixture of MBG:HA with pure bone allograft during impaction and subsequent endurance testing in a revision hip arthroplasty model. Materials and methods Large Sawbone femurs were prepared to represent a femur with bone loss (Sawbones, Sweden). 12 uniaxial strain gauges were attached to each femur at 0, 90, 180 and 270 degrees, at distal, midshaft, proximal points to measure hoop strain. Impaction grafting was performed using X-Change 2 instruments and an Instron servohydaulic machine for 2 distal impactions and 4 proximal impactions for 60 impactions each. The study consisted of four experimental groups: 1)Pure MBG, force of 1.98 kN 2)Pure MBG, force 3.63kN. 3)1:1 mixture of MBG: porous HA (pHA), 4)1:1 mixture MBG: non porous HA (npHA). 6 samples of each group were performed. The potted femur was loaded in a manner representing the walking cycle (1.98kN) at 1 Hz for 50 000 cycles. The displacement of the femoral head during loading was measured by two displacement transducers (LVDT) were mounted on aluminum brackets to measure vertical displacement and rotation.Study groups
Endurance testing
Problems associated with allograft are well known. The addition of hydroxyapatite (HA) to allograft has various mechanical advantages, especially within revision arthroplasty. The mixing of bone and HA results in mechanical properties different from the individual parts. However, at present the changes in material properties the mix have not been fully investigated and the optimum mixing ratio not characterized. A compressive uniaxial chamber was used to investigate the change in mechanical properties occurring with the addition of HA in varying proportions to morcellised bone graft (MBG). MBG was prepared using femoral heads donated from patients undergoing total hip replacement surgery using a bone mill in a standard manner. Non porous HA (npHA) was prepared using a precipitation method of Calcium Carbonate and Orthophosphoric acid. The porous HA, (pHA) is a 60% macroporosity HA commercially prepared. The uniaxial compression chamber was a 30mm diameter, steel chamber. Holes were drilled to allow fluid drainage. Loads were applied using a 10 kN load cell. Specimens were prepared in the volumetric proportions pure HA, pure MBG, 2:1, 1:1, 1:2 ratio of MBG to HA. The samples were subjected to compressive forces of incrementally increasing loads of up to 2 KN for 60 cycles. The sample was then allowed to creep under a stress of 2 kN. MBG was also tested up to forces of 7 kN. The mechanical parameters that were examined were the stiffness of the sample at the 60th cycle, (Ec60), and creepMaterials and methods
Chamber
The aim of this study was to investigate whether methylene blue dye, commonly used in sterile surgical marker pens, would have an effect on human chondrocyte viability, when cultured on a collagen membrane in-vitro. Bilayered collagen membranes were seeded in duplicate with 12 million human chondrocytes per ml and cultured for 24 hours under standard conditions. Group A consisted of a membrane marked with methylene blue ink on its smooth side, group B marked on its porous side, and group C acting as an unmarked control. At the end of the culture period the membranes were qualitatively analysed for cell survival by live/dead fluorescent staining under confocal microscopy.Introduction
Methods
To determine the optimum choice of treatment for the displaced intracapsular fracture in the elderly, 455 patients aged over 70 years with a displaced intracapsular fracture were entered into a prospective randomised trial. Treatment was either an uncemented Austin Moore hemiarthroplasty or reduction and internal fixation with three AO cancellous screws. Analysis of pre-operative characteristics of patients showed there was no significant difference between the two groups. Follow-up of surviving patients was continued for between seven to 15 years to determine the long-term outcome for the two treatment Methods: 90% of patients died during this follow-up period. Regarding short term outcomes, internal fixation resulted in a reduced mean operative time, operative blood loss and transfusion requirements. There was no significant difference in the length of hospital stay or incidence of general post-operative complications. There was no difference in either the short term or long-term mortality between the two procedures. The need for revision surgery to the hip was increased for those treated by internal fixation (7% versus 38% implant revision rate). There was no difference in the degree of residual pain between groups neither was there any difference in the number of patients requiring institutional care. There was a tendency to slightly better mobility for those treated by internal fixation although the Results: were not statistically significant. These results demonstrate that both treatment methods produce comparable final outcomes but internal fixation is associated with an increased re-operation rate.
This study surveys our patients to determine their experiences at airport security, establishes the detectability of common orthopaedic implants in an airport security scanner
A volunteer with metal implants strapped on and patients with implants in-situ walked through a gate scanner at a UK airport. Also, standard operating procedures at UK airports were ascertained.
There were 111 total knee replacements (TKR), 20 unicompartmental knee replacements (UKR), 2 bilateral UKR replacements, 17 bilateral TKR. Unlike previous studies from the U.K., virtually all patients with a TKR activated the gate scanner. Conversely, those with unicompartmental replacements did not. Patients are concerned about this possibility but are not informed at time of surgery and do not know what the procedures are if their implant is detected. The patient with the bilateral UKR did not set off the scanners where as the patient with the TKR did. A variety of surprisingly large trauma implants escaped detection.
The purpose of this study was to describe our experience of the Calaxo Osteoconductive interference screw (Smith &
Nephew) when used for both femoral and tibial graft fixation in Double Bundle ACL reconstruction. Since May 2006, all patients with an ACL deficient knee were reconstructed using the Double Bundle technique. All were followed prospectively and outcome data collected. Evidence of fixation failure was established subjectively by clinical examination (Lachman, Anterior Draw, Pivot Shift) and objectively via KT-1000 arthrometer. Following ethical approval, post-operative CT scans (immediate and 1 year) were performed on our first 10 patients allowing assessment of tunnel dimensions/fill. Thirty two patients (29 male, 3 female) with a mean age of 30 (range 18-46) were included. At last follow-up, no evidence of graft/fixation failure was found; KT-1000 mean side-side difference 1.4mm (range −3 to +6). All patients had a positive pivot shift preoperatively which was abolished postoperatively. One patient had a postoperative infection with no other complications reported. Radiologically the screws did not show complete resorption but areas of new bone were identified. We have shown satisfactory results with use of the Calaxo screw when used in Double Bundle Reconstruction. We have not had any cases of the adverse local soft tissue reaction, which has led to this screw being withdrawn from clinical use. Even when using a total of four screws in each knee. A previous study published by Seibold (2007) has shown tunnel widening and communication when suspensory fixation is used in Double Bundle reconstruction. This has the potential risk of leading to fracture between the tunnels. This has not been seen with the Calaxo screw which may be a result of the biological action of the screw which should ultimately lead to a reduction in these risks.
Evidence of fixation failure was established subjectively by clinical examination (Lachman, Anterior Draw, Pivot Shift) and objectively via KT-1000 arthrometer. Following ethical approval, post-operative CT scans (immediate and 1 year) were performed on our first 10 patients allowing assessment of tunnel dimensions/fill.
A previous study published by Seibold (2007) has shown tunnel widening and communication when suspensory fixation is used in Double Bundle reconstruction. This has the potential risk of leading to fracture between the tunnels. This has not been seen with the Calaxo screw which may be a result of the biological action of the screw which should ultimately lead to a reduction in these risks.