Background. Immersive virtual reality (VR) demonstrates potential benefits in patients with chronic low back pain (CLBP). However, few studies have investigated the feasibility and the acceptability of introducing immersive VR for use with patients with CLBP and in the Kingdom of Saudi Arabia (KSA). Aim. To investigate immersive VR's feasibility, tolerability, and acceptability as a rehabilitation intervention for adult patients with CLBP and explore the views of relevant Health Care Practitioners (HCPs) in the KSA. Methodology and Methods. A multi-centre, mixed-methods, explanatory sequential design was adopted to test immersive VR's feasibility, tolerability, and acceptability. An uncontrolled feasibility trial was conducted. The immersive VR intervention involved a training session followed by three sessions over one week using commercially available hardware and software. Feasibility outcomes were collected from patients immediately post-intervention. Patients and HCPs were recruited for semi-structured interviews. Results. Thirty-three patients and three HCPs were recruited. The feasibility a priori criteria were met for recruitment, retention, dropout, completeness of questionnaire data, treatment compliance and fidelity. Adverse events included one who reported aggravation of tinnitus, whereas two experienced dizziness. Qualitative data suggested that entertainment and motivation were key enablers. Barriers included technological capability and HCPs’ perceptions that immersive VR was time-consuming. Conclusion. The results suggested that immersive VR was feasible, acceptable, and tolerable among patients with CLBP and HCPs in clinical settings in the KSA. Further research focusing on the effectiveness is warranted in this field. Conflicts of Interest. None. Sources of Funding. None. Trial registration number. ISRCTN14434517

Current treatment options for displaced acetabular fractures in elderly patients include non-surgical management, surgical fixation and surgical fixation with simultaneous hip replacement, the so-called “fix-and-replace”™. There remains a paucity of evidence to guide surgeons in decision making for these difficult injuries. The aim of this study was to assess the feasibility of performing an appropriately powered RCT between treatment options for acetabular fractures in older patients. This was an NIHR funded feasibility triple-arm RCT with participation from 7 NHS MTCs. Patients older than 60 were recruited if they had an acetabular fracture deemed sufficiently displaced for the treating surgeon to consider surgical fixation. Randomisation was performed on a 1:1:1 basis. The three treatment arms were non-surgical management, surgical fixation and fix-and-replace. Feasibility was assessed by willingness of patients to participate and clinicians to recruit, drop out rate, estimates of standard deviation to inform the sample size calculation for the full trial and completion rates to inform design of a future definitive trial. EQ-5D was the primary outcome measure at 6 months, OHS and Disability Rating Index were secondary outcome measures. Of 117 eligible patients, 60 were randomised whilst 50 declined study participation. Nine patients did not receive their allocated intervention. Analysis was performed on an intention to treat basis. During the study period 4 patients withdrew before final review, 4 patients died and 1 was lost to follow-up. The estimated sample size for a full scale study was calculated to be 1474 participants for an EQ-5D MCID of 0.06 with a power of 0.8. This feasibility study suggests a full scale trial would require international collaboration. This study also has provided observed safety data regarding mortality and morbidity for the fix-and-replace procedure to aid surgeons in the decision-making process when considering treatment options

Introduction. Approximately 20-25% of patients having joint replacement in the UK have moderate-severe frailty. Frailty is associated with poorer outcomes after joint replacement. Targeting frailty pre-operatively with exercise and protein supplementation could improve post-operative outcomes. Prior to conducting a randomised controlled trial (RCT), a feasibility study was necessary to inform trial design and delivery. Method. We conducted a randomised feasibility study with embedded qualitative work. Patients aged ≥65 years, frail and undergoing THR or TKR were recruited from three UK hospitals. Participants were randomly allocated on a 1:1 ratio to the intervention or usual care group. The intervention group had a 1:1 appointment with a physiotherapist and were provided with a home-based, tailored daily exercise programme and a daily protein supplement for 12 weeks before their operation, supported by six telephone calls from a physiotherapist. Questionnaires were administered at baseline and 12 weeks after randomisation. Interviews were conducted with 19 patients. Feasibility outcomes were eligibility and recruitment rates, intervention adherence, and acceptability of the trial and the intervention. Result. 411 patients were sent a screening pack. Of the 168 patients who returned a screening questionnaire, 79 were eligible and consented to participate, and 64 were randomised. Of the 33 participants randomised to the intervention, 26 attended the intervention appointment. Eighteen participants (69%) received all six intervention follow-up telephone calls. Nineteen participants completed an intervention adherence log; 13 (68%) adhered to the exercise programme and 11 (58%) adhered to the protein supplementation. The overall retention rate was 86% at 12 weeks. The 12-week follow-up questionnaire was returned by 84% of participants who were sent a questionnaire. Interviews found that the trial and intervention were generally acceptable, but areas of potential improvements were identified. Conclusion. This study demonstrated that a larger study is possible and has identified improvements to optimise the design of a RCT

Percutaneous fixation of scaphoid fractures has become popular in recent years, mainly due to its reduced complexity compared to open surgical approaches. Fluoroscopy is currently used as guidance for this percutaneous approach, however, as a projective imaging modality, it provides only a 2D view of the complex 3D anatomy of the wrist during surgery, and exposes both patient and physician to harmful X-ray radiation. To avoid these drawbacks, 3D ultrasound has been suggested to provide imaging for guidance as a widely available, real-time, radiation-free and low-cost modality. However, the blurred, disconnected, weak and noisy bone responses render interpretation of the US data difficult so far. In this work, we present the integration of 3D ultrasound with a statistical wrist model to allow development of an improved ultrasound-based guidance procedure. For enhancement of bone responses in ultrasound, a phase symmetry based approach is used to exploit the symmetry of the ultrasound signal around the expected bone location. We propose an improved estimation of the local phase symmetry by using the local spectrum variation of the ultrasound image. The statistical wrist model is developed through a group-wise registration based framework in order to capture the major modes of shape and pose variations across 30 subjects at different wrist positions. Finally, the statistical wrist model is registered to the enhanced ultrasound bone surfaces using a probabilistic registration approach. Feasibility experiments are performed using two volunteer wrists, and the results are promising and warrant further development and validation to enable ultrasound guided percutaneous scaphoid fracture reduction

Background and aims. The Keele STarT Back approach is effective for stratifying patients with low back pain in primary care, but a similar approach has not been tested with a broader range of patients with musculoskeletal (MSK) pain. We report a feasibility and pilot trial examining the feasibility of a future main trial of a primary care based, risk-stratification (STarT MSK) approach for patients with back, neck, knee, shoulder or multi-site pain. Methods. A pragmatic, two-parallel arm, cluster randomised controlled trial (RCT) in 8 GP practices (4 stratified care involving use of the Keele STarT MSK tool and matched treatment options: 4 usual care). Following screening, adults with one of the five most common MSK pain presentations were invited to take part in data collection over 6 months. Feasibility outcomes included exploration of selection bias, recruitment and follow-up rates, clinician engagement with using the Keele STarT MSK tool and matching patients to treatments. Results. 524 participants (231-stratified care, 293-usual care) were recruited (target n=500) over 7 months (target 3 months), with 15-withdrawals (5-intervention, 10-controls). Minimal selection bias was identified between participants/non-participants, or trial arms. The pain-intensity follow-up rate was 88%. Clinicians used the STarT MSK tool in 41% of relevant consultations (judged as ‘partial success’) and adhered to recommended matched treatments in 69% of cases (judged as ‘success’). Conclusions. A future main RCT is feasible, with some amendments in the wording of the tool and the matched treatment options, to determine the clinical and cost-effectiveness of stratified care versus usual care for patients with MSK pain. Conflicts of interest: ‘No conflicts of interest’. Sources of Funding: This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research scheme (grant number: RP-PG-1211-20010). Nadine Foster is a NIHR Senior Investigator and was supported through an NIHR Research Professorship (NIHR-RP-011-015). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care

Displaced acetabular fractures in the older patient present significant treatment challenges. There is evidence the morbidity and mortality associated is similar to the fractured neck of femur cohort. Despite growing literature, there remains significant controversy regarding treatment algorithms; varying between conservative management, to fracture fixation and finally surgical fixation and simultaneous THA to allow immediate full weight bearing.

£250k NIHR, Research for Patient Benefit (Ref: PB-PG-0815-20054). Trial ethical approval (17/EE/0271). After national consultation, 3 arms included; conservative management, fracture fixation and simultaneous fracture fixation with THA. Statistical analysis required minimum 12 patients/3 arms to show feasibility, with an optimum 20/arm. Inclusion criteria; patients >60 years & displaced acetabular fracture. Exclusion criteria: open fracture, THA in situ, pre-injury immobility, polytrauma. Primary outcome measure - ability recruit & EQ-5D-5L at 6 months. Secondary outcome measures (9 months); OHS, Disability Rating Index, radiographs, perioperative physiological variables including surgery duration, blood loss, complications and health economics.

11 UK level 1 major trauma centres enrolled into the trial, commenced December 2017. Failure surgical equipoise was identified as an issue regarding recruitment. Full trial recruitment (60 patients) achieved; 333 patients screened. 66% male, median age 76 (range 63–93), median BMI 25 (range 18–37), 87% full mental capacity, 77% admitted from own home. 75% fall from standing height. 60% fractures; anterior column posterior hemi-transverse. Trial feasibility confirmed December 2020. Presented data- secondary outcomes that are statistically significant in improvement from baseline for only the fix and replace arm, with acceptable trial complications. Issues are highlighted with conservative management in this patient cohort.

Our unique RCT informs design and sample size calculation for a future RCT. It represents the first opportunity to understand the intricacies of these treatment modalities. This RCT provides clinicians with information on how best to provide management for this medically complex patient cohort.

Obesity is associated with worse outcomes following total knee/hip arthroplasty (TKA/TKA). This study aimed to determine the feasibility of a dietitian-led low-inflammatory weight-loss program for people with obesity awaiting arthroplasty.

Quasi-experimental pilot study enrolled people with obesity waitlisted for primary TKA/THA into ‘usual care’ (UC) or weight-loss (low-inflammatory diet) program (Diet). Recruitment occurred between July 2019 and February 2020 at Fairfield and Campbelltown Hospitals. Assessments at baseline, pre-surgery, time of surgery and 90-days following surgery included anthropometric measurements, patient-reported outcomes, serum biomarkers and 90-day postoperative complication rate.

97 people consented to the study (UC, n=47, mean age 67, BMI 37, TKA 79%; Diet, n=50, mean age 66, BMI 36, TKA 72%). Baseline characteristics indicated gross joint impairments and poor compliance with a low-inflammatory diet. Study feasibility criteria included recruitment rate (52%), proportion of diet patients that improved compliance to low-inflammatory diet by ≥10% (57%) and had ≥60% attendance of dietitian consultations (72%), proportion of patients who undertook serum biomarkers (55%).

By presurgery assessments, the diet group had more patients who cancelled their surgery due to symptom improvement (4 vs 0), reduced waist-circumference measurements, increased compliance with the Low-Inflammatory diet and preservation of physical activity parameters. More usual care participants experienced at least one postoperative complication to 90-days (59% vs 47%) and were discharged to inpatient rehabilitation (21% vs 11%). There was no difference in weight change, physical function, and patient-reported outcome measures from pre-surgery to 90-days post-surgery, and length of hospital stay.

Using pre-determined feasibility criteria, conducting a definitive trial is not feasible. However, intervention audit demonstrated high intervention fidelity.

Pilot data suggest our program may promote weight loss but the clinical effects for most are modest. Further research utilising a stronger intervention may be required to assess the effectiveness of a pre-arthroplasty weight-loss intervention.

Abstract

Knee arthroscopy is typically approached from the anterior, posteromedial and posterolateral portals. Access to the posterior compartments through these portals can cause iatrogenic cartilage damage and create difficulties in viewing the structures of the posterior compartments. The purpose of this study was to assess the feasibility of needle arthroscopy using direct posterior portals as both working and visualising portals.

For workability, the needle scope was inserted advanced from anterior between the cruciate ligament bundle and the lateral wall of the medial femoral condyle until the posterior compartments were visualised. For visualisation, direct postero-lateral and -medial portals were established. The technique was performed in 9 knees by two experienced researchers.

Workability and instrumentation of the posteromedial compartment and meniscus was achieved in 56%. The posterior horns could not be visualised in four specimens as the straight lens could not provide a more medial field of view. Visualisation from the direct medial posterior portal allowed a clear view of the medial meniscus, femoral condyle and posterior cruciate ligament in all specimens. Workability and instrumentation of the posterolateral compartment was not possible with the needle scope.

Direct posterior approaches for the posteromedial compartment access are challenging with the current needle scope options and could only be achieved in over 50%. The postero-lateral compartment was not accessible. An angled lens or a flexible Needle scope would be better suited for developing this technique further.

Studies have shown that 10–30% patients do not achieve optimal function outcomes after total hip replacement (THR). High quality randomised controlled trials (RCTs) evaluating the clinical and cost-effectiveness of techniques to improve functional outcomes after THR are lacking. We performed this study to evaluate the feasibility of a RCT comparing patient-reported functional outcomes after hybrid or fully cemented THR (ISRCTN11097021).

Patients were recruited from two centres and randomised to receive either a fully cemented or hybrid THR. Data collection included Patient Reported Outcome Measures (PROMs), non-serious adverse events of special interest (AESI), serious adverse device effects (SADE) and NHS resource use. Qualitative interviews were undertaken to understand a) patient experiences of study processes and their reasons for taking part or not, and b) to understand surgeons’ perceptions of the study, factors affecting willingness to participate, and barriers to implementation of the future RCT findings.

The target of 40 patients were successfully recruited for the feasibility RCT; the ratio of successful recruitment to eligible patients was 0.61 across both sites. Treatment crossovers occurred in four patients, all related to bone quality. Four patients were withdrawn due to not undergoing surgery within the study window because of the pandemic. Follow-up was 100% and PROMs were completed by all patients at all time points. The feasibility of conducting a within-trial cost-utility analysis was demonstrated. Interviews were conducted with 27 patients and 16 surgeons. Patients and surgeons generally found the study procedures acceptable and workable. Some declined participation because they did not want treatment allocated at random, or because blinding was off-putting. Surgeons’ perceptions of equipoise varied, and implementation of findings from the future RCT would need to recognise the ‘craft’ nature of surgery and the issue of training.

We conclude that a full RCT with economic analysis will be both feasible and practicable, although mechanisms to safely implement potential changes to practice because of RCT findings may need consideration by the wider arthroplasty community.

Conventional fracture courses utilise prefabricated sawbones that are not realistic or patient specific. The aim of this study is to determine the feasibility of creating 3D fracture models and utilising them in fracture courses to teach surgical technique.

We selected an AO type 2R3C2 fracture that underwent open reduction internal fixation. De-identified CT scan images were converted to a stereolithography (STL) format. This was then processed using Computer Aided Design (CAD) to create a virtual 3D model. The model was 3D printed using a combination of standard thermoplastic polymer (STP) and a porous filler to create a realistic cortical and cancellous bone. A case-based sawbone workshop was organised for residents, unaccredited registrars, and orthopaedic trainees comparing the fracture model with a prefabricated T-split distal radius fracture. Pre-operative images aided discussion of fixation, and post-operative x-rays allowed comparison between the participants fixation. Participants were provided with identical reduction tools. We created a questionnaire for participants to rate their satisfaction and experience using a Likert scale.

The 3D printed fracture model aided understanding and appreciation of the fracture pattern and key fragments amongst residents and unaccredited trainees. Real case-based models provided a superior learning experience and environment to aid teaching. The generic sawbone provided easier drilling and inserting of screws. Preliminary results show that the cost of 3D printing can be comparable to generic sawbones.

It is feasible to create a fracture model with a real bone feel. Further research and development is required to determine the optimum material to use for a more realistic feel.

The use of 3D printed fracture models is feasible and provides an alternative to generic sawbone fracture models in providing surgical training to residents.

The purposes of this study were to evaluate the accuracy and feasibility of a robotic preparation for acetabular metal augments in patients with developmental dysplasia of the hip (DDH). Mako robotic arm reaming was used in 7 DDH to prepare the bony cavities for both Trident PSL cups and Tritanium acetabular wedge augments in six hips with Crowe 2 or 3 DDH. In CT-based planning, a properly sized cup was placed in the original acetabulum, and the same sized cup was also placed to fit the superolateral acetabular defect. The coordinates of the planned positions of cup and augment were recorded to manage the robotic arm reaming. After registration of the patient's pelvis, robotic reaming was performed first for the augment, then, for the cup by changing the target position of reaming as planned. The accuracy of the cup and augment placement was assessed on postoperative CT. To evaluate the feasibility of the robotic procedure, the OR time and blood loss were compared with those of 13 patients who received the same cup and augment systems with a conventional technique. All procedures were done without fracture or fixation failure. There were no differences in OR time or blood loss between the two procedures. Postoperative CT measurements of the distance between the cup center and the augment sphere center showed less than 2mm difference from the Mako preoperative planning.

Although a longer time of follow up evaluation is mandatory, our robotic acetabular augment preparation technique is accurate and feasible.

Introduction

Previous studies have shown the potential for virtual reality (VR) immersion as a promising technique for pain and anxiety management. The aim of our study was to evaluate the feasibility of VR in the management of pain and anxiety during post-op external fixator care procedures.

To date, few studies have investigated the feasibility of the loop-mediated isothermal amplification (LAMP) assay for identifying pathogens in tissue samples. This study aimed to investigate the feasibility of LAMP for the rapid detection of methicillin-susceptible or methicillin-resistant Staphylococcus aureus (MSSA or MRSA) in tissue samples, using a bead-beating DNA extraction method. Twenty tissue samples infected with either MSSA (n = 10) or MRSA (n = 10) were obtained from patients who underwent orthopedic surgery for suspected musculoskeletal infection between December 2019 and September 2020. DNA was extracted from the infected tissue samples using the bead-beating method. A multiplex LAMP assay was conducted to identify MSSA and MRSA infections. To recognize the Staphylococcus genus, S. aureus, and methicillin resistance, 3 sets of 6 primers for the 16S ribosomal ribonucleic acid (rRNA) and the femA and mecA genes were used, respectively. The limit of detection and sensitivity (detection rate) of the LAMP assay for diagnosing MSSA and MRSA infection were analyzed. The results of this study suggest that the LAMP assay performed with tissue DNA samples can be a useful diagnostic method for the rapid detection of musculoskeletal infections caused by MSSA and MRSA.

Abstract

Waiting times for arthroplasty surgery in Northern Ireland are among the longest in the National Health Service, which have been further lengthened by the onset of the SARS-CoV-19 global pandemic in March 2020. The Department of Health (DoH) in Northern Ireland has announced a new Elective Care Framework (ECF), with the framework proposing that by March 2026 no patient will wait more than 52 weeks for inpatient/day case treatment. We aimed to assess the feasibility of achieving this with reference to Total Hip Arthroplasty (THA).

Waiting list information was obtained via a Freedom of Information request to the DoH (May 2021) and National Joint Registry data was used to determine baseline operative numbers. Mathematical modelling was undertaken to calculate the time taken to meet the ECF target and also to determine the time to clear the waiting lists for THA using the number of patients currently on the waiting list and percentage operating capacity relative to pre-Covid-19 capacity to determine future projections.

As of May 2021, there were 3,757 patients awaiting primary THA in Northern Ireland. Prior to April 2020, there were a mean 2,346 patients/annum added to the waiting list for primary THA and there were a mean 1,624 primary THAs performed per annum.

The ECF targets for THA will only be achieved in 2026 if operating capacity is 200% of pre COVID-19 pandemic capacity and will be achieved in 2030 if capacity is 170%. Surgical capacity must exceed pre-Covid capacity by at least 30% to meet ongoing demand.

THA capacity was significantly reduced following resumption of elective orthopaedics post-COVID-19 (22% of pre-COVID-19 capacity – 355 THAs/annum post-COVID-19 versus 1,624/annum pre-COVID-19).

This modelling demonstrates that, in the absence of major funding and reorganisation of elective orthopaedic care, the targets set out in the ECF will not be achieved with regards to hip arthroplasty. Waiting times for THA surgery in the NHS in Northern Ireland are likely to remain greater than 52 weeks for most of this decade.

Introduction and Objective

Low back pain (LBP) is a major cause of long-term disability in adults worldwide and it is frequently attributed to intervertebral disc (IVD) degeneration. So far, no consensus has been reached regarding appropriate treatment and LBP management outcomes remain disappointing. Spine unloading or traction protocols are common non-surgical approaches to treat LBP. These treatments are widely used and result in pain relief, decreased disability or reduced need for surgery. However, the underlying mechanisms -namely, the IVD unloading mechanobiology- have not yet been studied. The aim of this first study was to assess the feasibility of IVD unloading in a large animal organ culture set-up and evaluate its impact on mechanobiology.

Abstract

Advances in algorithms developed with sensor data from smart phones demonstrates the capacity to passively collect qualitative gait metrics. The purpose of this feasibility study was to assess the recovery of these metrics following joint reconstruction. A secondary data analysis of an ethics approved global, multicenter, prospective longitudinal study evaluating gait quality data before and after primary total knee arthroplasty (TKA, n=476), partial knee arthroplasty (PKA, n=139), and total hip arthroplasty (THA, n=395). A minimum 24 week follow-up was required (mean 45±12, range 24 - 78). Gait bouts and gait quality metrics (walking speed, step length, timing asymmetry, and double support percentage) were collected from a standardized smartphone operating system. Pre- and post-operative values were compared using paired-samples t-tests (p<0.05).

A total of 595 females and 415 males with a mean age of 61.9±9.3 years and mean BMI of 30.2±6.1 kg/m² were reviewed. Walking speeds were lowest at post-operative week two (all, p<.001). Speeds exceeded pre-operative means consistently by week 21 (p=0.015) for PKA, and week 13 (p=0.007) for THA. The average weekly step length was lowest in post-operative week two (all, p<0.001). PKA and THA cases achieved pre-operative step lengths by week seven (p=0.064) and week 9 (p=0.081), respectively. The average weekly gait asymmetry peaked at week two post-operatively (all, p <0.001). Return to pre-operative baseline asymmetry was achieved by week 11 (p=0.371) for TKA, week six (p=0.541) for PKA, and week eight (p=.886) for THA. Double limb support percentages peaked at week two (all, p<0.001) and returned to pre-operative levels by week 24 (p=0.089) for TKA, week 12 (p=0.156) for PKA, and week 10 (p=0.143) for THA.

Monitoring gait quality in real-world settings following joint reconstruction using smartphones is feasible, and may provide the advantage of removing the Hawthorne effect related to typical gait assessments and in-clinic observations.

Gait analysis is an indispensable tool for scientific assessment and treatment of individuals whose ability to walk is impaired. The high cost of installation and operation are a major limitation for wide-spread use in clinical routine.

Advances in Artificial Intelligence (AI) could significantly reduce the required instrumentation. A mobile phone could be all equipment necessary for 3D gait analysis. MediaPipe Pose provided by Google Research is such a Machine Learning approach for human body tracking from monocular RGB video frames that is detecting 3D-landmarks of the human body.

Aim of this study was to analyze the accuracy of gait phase detection based on the joint landmarks identified by the AI system.

Motion data from 10 healthy volunteers walking on a treadmill with a fixed speed of 4.5km/h (Callis, Sprintex, Germany) was sampled with a mobile phone (iPhone SE 2nd Generation, Apple). The video was processed with Mediapipe Pose (Version 0.9.1.0) using custom python software. Gait phases (Initial Contact - IC and Toe Off - TO) were detected from the angular velocities of the lower legs. For the determination of ground truth, the movement was simultaneously recorded with the AS-200 System (LaiTronic GmbH, Innsbruck, Austria).

The number of detected strides, the error in IC detection and stance phase duration was calculated.

In total, 1692 strides were detected from the reference system during the trials from which the AI-system identified 679 strides. The absolute mean error (AME) in IC detection was 39.3 ± 36.6 ms while the AME for stance duration was 187.6 ± 140 ms.

Landmark detection is a challenging task for the AI-system as can clearly be seen be the rate of only 40% detected strides. As mentioned by Fadillioglu et al., error in TO-detection is higher than in IC-detection.