Aims

Arthroplasties of the elbow, including total elbow arthroplasty, radial head arthroplasty, distal humeral hemiarthroplasty, and radiocapitellar arthroplasty, are rarely undertaken. This scoping review aims to outline the current research in this area to inform the development of future research.

Abstract. Introduction. In recent years, CTA has been an effective training adjunct for orthopaedic procedures. ACLR is a complex procedure with a steep learning curve. Aim. To design a multimedia CTA learning tool for ACLR using a modified Delphi methodology. Methodology:. CTA generation: A modified Delphi method was used to generate a list of Technical Steps (TS), Decision Points (DP) and errors/solutions for an ACLR that was approved by an expert consensus amongst four, fellowship-trained knee surgeons. A technical workflow was designed to generate the audio-visual tool. Pilot study: 30 novice trainees were granted access to the CTA tool and then performed the ACLR in a cadaveric simulation workshop. A 5-point Likert scale aimed to qualitatively assess if the CTA was useful to their learning. Results:. CTA generation: 156 TS and 79 DP were included for an ACLR procedure which was divided into 7 phases. The audio-visual component was combined with the written tool to design the final CTA tool. Pilot study: 95% of trainees suggested the CTA tool would be useful before carrying out an ACLR in the operating theatre. They agreed it made their ACLR learning more effective. Conclusion:. We have designed a novel and easily accessible CTA tool to standardise teaching of ACLR surgery. Novice surgeons verify the value of the CTA as an adjunct to their apprenticeship training. Future work: A Randomised Controlled Trial (RCT) is currently being planned to evaluate whether there are any objective benefits of this CTA to train surgeons performing an ACLR

Abstract. Introduction. Higher than expected rates of tibial loosening with the ATTUNE® total knee arthroplasty (TKA) implant has been reported. Component loosening can be associated with the development of radiolucency lines (RLL) and our study aim was to systematically assess the reported rates of these. Methodology. A systematic search was undertaken using the Cochrane methodology in four online databases. Identified studies were assessed and screened against predetermined inclusion criteria. Meta-analysis was conducted using a random-effects model. Results. Nine studies (n=2,727 TKAs) from 6,590 titles met the inclusion criteria: 1 Randomised Controlled Trial (n=74), 1 prospective cohort (n=200), 4 retrospective cohort (n=1,639), and 3 case-series (n=814). All used the 2013 ATTUNE® design. In meta-analysis: 8 studies (n=1,440 ATTUNE TKAs) reported an overall prevalence of 11% (95%CI: 6.4-18.3%) for medial tibia RLL; 7 studies (n=940) a 12.3% (95%CI: 4.0-32%) rate of any tibia RLL.; 5 studies (n=736) femoral RLL in 11% (95%CI: 7.2-106.5%) and 7 studies (n=896) any RLL in 20.7% (95%CI: 13.4-30.6%). Meta-analysis of 4 studies (n=1,036) comparing the ATTUNE® with another implant (PFC Sigma®, LCS®, or PERSONA®) showed a higher risk of medial tibia RLL (OR: 2.538; 95%CI: 1.397-4.611, P=0.002) and any RLL (OR: 2.725; 95%CI: 1.302-5.703, P=0.008) in the ATTUNE® group. Conclusions. The 2013 ATTUNE® TKA system is associated with high rates of radiolucency around the tibial and femoral components. Comparative studies suggesting these rates are more than double those of other systems. Radiolucency may be a herald of component loosening, therefore, close surveillance of this implant is recommended

Abstract. Introduction. The postoperative inflammatory response may be implicated in the aetiology of patient dissatisfaction following Total Knee Arthroplasty. Robotic-arm assisted TKA has been associated with reduced bone and soft tissue trauma. The objective of this Randomised Controlled Trial was to compare the inflammatory response in conventional Jig-based versus robotic arm-assisted TKA and examine the relationship with patient reported outcome measures and functional outcomes. Methodology. 30 patients with knee osteoarthritis were randomised to either conventional or robotic-arm assisted TKA. Blood samples were collected for up to 28 days post-operatively and intraarticular drain samples at 6 and 24 hours, to ascertain the systemic and local inflammatory responses. The Spearman's correlation was utilised to evaluate the relationship with PROMs and functional outcomes. Results. Reduced IL-6 drain fluid levels were noted at 6 hours [798.54 vs. 5699.2, p=0.026] and 24 hours and IL-8 at 6 hours. Patients in the robotic group had lower pain scores on post-operative day 1, 2 and 7. PROM scores were comparable at 2 years. Statistically significant correlations were evident between all serum markers except IL-1b on the 7th postoperative day and self-reported pain; between drain IL-8 levels and self-reported pain; between drain IL-6, IL-8 and TNF-a levels (6-hours) and knee flexion and extension. Conclusion. Robotic-arm assisted TKA was associated with a reduced postoperative local and systemic inflammatory responses. A moderate correlation with self-reported pain, knee flexion and extension was also demonstrated. Longer-term data and further validation on a larger scale, will be key to developing the optimal TKA procedure

Aims

A multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial.

Femoroacetabular impingement (FAI) is a condition of the hip where there is a mismatch of the femoral head and hip acetabulum. This mismatch creates abnormal contact between the bones and causes hip pain which can lead to damage, and eventually osteoarthritis of the hip. The diagnosis and treatment of FAI has become one of the most popular clinical scenarios in orthopaedic surgery, with hip arthroscopy procedures increasing exponentially over the past five years. Surgical intervention usually involves correcting the existing deformities by reshaping the ball and socket (“osteoplasty” or “rim trimming”) so that they fit together more easily while repairing any other existing soft tissue damage in the hip joint (e.g. labral repair). Although correction of the misshaped bony anatomy and associated intra-articular soft tissue damage of the hip is thought to appease impingement and improve pain and function, the current evidence is based on small, observational, and low quality studies. A lack of definitive evidence regarding the efficacy of osteochondroplasty in treating FAI fueled the design and execution of the FIRST randomized controlled trial (RCT). FIRST evaluated the impact of surgical correction of the hip impingement morphology with arthroscopic osteochondroplasty versus arthroscopic lavage on pain, function, and quality of life in adults aged 18–50 years diagnosed with non-arthritic FAI at one year.

FIRST was a large definitive RCT (NCT01623843) enrolling patients with FAI requiring surgical intervention across 11 international clinical sites. Participants were randomized to either arthroscopic osteochondroplasty (shaving of bone) or lavage (washing the joint of painful inflammation debris). The primary outcome was patient-reported pain within one year of the initial surgery measured using the Visual Analogue Scale (VAS). Secondary outcomes included function, health utility, and health-related quality of life using several general and hip-centric health questionnaires. An independent, blinded adjudication committee evaluated the quality of surgery, re-operations, and other patient complications. Patients and data analysts were blinded to the treatment groups.

Two-hundred and twenty participants were enrolled into the FIRST trial over a six-year period (pilot phase: N=50, from 2012–2013 and definitive phase: N=170, from 2015–2018) at 11 clinical sites in Canada, Finland, and Denmark. The FIRST results will be released at the ISAKOS annual meeting as follows. The absolute difference in rate of pain reduction between groups was XX (95% CI: YY-YY, p=X). The mean differences of the Short-Form 12 (SF-12, MCS and PCS), Hip Outcome Score (HOS), International Hip Outcome Tool (iHOT-12), and EuroQol 5-Dimensions (EQ-5D) between groups are XX (95% CI: YY-YY, p=X)…, respectively. Reoperations occurred in XX of 220 (X%) patients over the one-year follow up period (OR:XX, 95% CI: YY-YY, p=X) and the patients treated with arthroscopic osteochondroplasty conferred the following risk of reoperation within one-year compared to arthroscopic lavage (RR:XX, 95% CI: YY-YY, p=X).

This RCT represents major international efforts to definitively identify the optimal treatment strategy for FAI. The results of this trial will change practice, being used to prevent chronic hip pain and loss of function caused by hip osteoarthritis.

Purpose of the study. To investigate the feasibility of undertaking a definitive Randomised Controlled Trial (RCT) to determine the effectiveness of early physiotherapy for sciatica. Methods. Patients over 18 presenting to their G.P with sciatica were eligible to participate in the study, those without a clear understanding of English or had co-morbidities preventing rehabilitation were ineligible. Process and patient reported outcomes including self-rated disability, pain and general health, were collected at baseline, 6,12 and 26 weeks post randomisation. Participants were randomised into either early physiotherapy, receiving treatment within 2 weeks after randomisation or usual care with physiotherapy commencing 6 weeks post randomisation. Both groups received up to 6 treatment sessions of a patient-centred, goal orientated physiotherapy programme specific to their needs. Results. 80 participants were recruited in 10 G.P practices over 34 weeks and randomised to either early physiotherapy (n= 42) or usual care (n=38). Follow-up rates at 26 weeks were 36 (86%) in the early intervention physiotherapy group and 32 (84%) in the usual care. All feasibility objectives were achieved. The mean area under the curve for the Oswestry Disability Index (ODI) over the 26 weeks was and 16.0 (SD 14.0) in the early physiotherapy group and 16.6 (SD 11.4) in the usual care group. A difference of −0.6 (95% CI: −0.68 to 5.6) in favour of the intervention group. Conclusion. The results of the study suggest a full RCT is feasible and will provide evidence as to the optimal timing of physiotherapy for patients with sciatica. No conflicts of interest for any authors. Sources of funding: MR is the recipient of a HEE/NIHR Clinical Doctoral Research Fellowship, which funded the study

Purposes of the study and background

Pain of lumbar facet-joint origin is a common cause of low back pain in adults, and may lead to chronic pain and disability. At present, there is no definitive research to support the use of targeted lumbar facet-joint injections to manage this pain.

The study's objective was to assess the feasibility of carrying out a definitive study to evaluate the clinical- and cost-effectiveness of lumbar facet-joint injections compared to a sham procedure.

Background

Recruitment to time and target in clinical trials is a key challenge requiring careful estimation of numbers of potential participants. The SCOPiC trial ((HTA 12/201/09) (ISRCTN75449581)) is investigating the clinical and cost-effectiveness of stratified care for patients with sciatica in primary care. Here, we describe the approaches followed to achieve recruitment of our required sample size (n=470), the challenges encountered and required adaptations.

Aim

Current standard of care in the management of bone and joint infection commonly includes a 4–6 week course of intravenous (IV) antibiotics but there is little evidence to suggest that oral antibiotic therapy results in worse outcomes. The primary objective was to determine whether oral antibiotics are non-inferior to IV antibiotics in this setting.

Aim

To assess the influence of route of antibiotic administration on patient-reported outcome measures (PROMS) of individuals treated for hip and knee infections in the OVIVA multi-centre randomised controlled trial.

Objectives

This study reports on a secondary exploratory analysis of the early clinical outcomes of a randomised clinical trial comparing robotic arm-assisted unicompartmental knee arthroplasty (UKA) for medial compartment osteoarthritis of the knee with manual UKA performed using traditional surgical jigs. This follows reporting of the primary outcomes of implant accuracy and gait analysis that showed significant advantages in the robotic arm-assisted group.

Objectives

The objective of this study was to assess all evidence comparing the Thompson monoblock hemiarthroplasty with modular unipolar implants for patients requiring hemiarthroplasty of the hip with respect to mortality and complications.

Background

Avulsion fractures of the base of the fifth metatarsal are some of the commonest foot injuries. The robust scientific evidence on the optimal non-operative treatment of these fractures is scant. We designed and conducted a prospective randomised non-inferiority controlled trial of symptomatic treatment versus cast immobilisation with the null hypothesis that cast immobilisation gave substantial benefit over the symptomatic treatment in terms of patient reported outcome measures(PROMs). The alternative hypothesis was that symptomatic treatment was not inferior.

Background. Chronic pain after joint replacement is common, affecting approximately 10% of patients after total hip replacement (THR) and 20% of patients after total knee replacement (TKR). Heightened generalised sensitivity to nociceptive input could be a risk factor for the development of this pain. The primary aim of this study was to investigate whether preoperative widespread pain sensitivity was associated with chronic pain after joint replacement. Methods. Data were analysed from 254 patients receiving THR and 239 patients receiving. TKR. Pain was assessed preoperatively and at 12 months after surgery using the Western Ontario and McMaster Universities Osteoarthritis Pain Scale. Preoperative widespread pain sensitivity was assessed through measurement of pressure pain thresholds (PPTs) at the forearm using an algometer. Statistical analysis was conducted using linear regression and linear mixed models, and adjustments were made for confounding variables. Results. In both the THR and TKR cohort, lower PPTs (heightened widespread pain. sensitivity) were significantly associated with higher preoperative pain severity. Lower PPTs were also significantly associated with higher pain severity at 12 months after surgery in the THR cohort. However, PPTs were not associated with the change in pain severity from preoperative to 12 months postoperative in either the TKR or THR cohort. Conclusions. These findings suggest that although preoperative widespread pressure pain sensitivity is associated with pain severity before and after joint replacement, it is not a predictor of the amount of pain relief that patients gain from joint replacement surgery, independent of preoperative pain severity. Level of Evidence. 2. Approvals. The APEX trials were registered as an International Standardised Randomised Controlled Trial (96095682), approved by Southampton and South West Hampshire Research Ethics Committee(09/H0504/94) and all participants provided informed written consent

Background. To investigate whether the interaction between pre-operative widespread hyperalgesia and radiographic osteoarthritis (OA) was associated with pain severity before and after total hip replacement (THR) and total knee replacement (TKR). Methods. Data were analysed from 232 patients receiving THR and 241 receiving TKR. Pain was assessed pre-operatively and at 12 months post-operatively using the WOMAC Pain Scale. Widespread hyperalgesia was assessed through forearm pressure pain thresholds (PPTs) measured using an algometer. The severity of radiographic OA was evaluated using the Kellgren and Lawrence scheme. Statistical analysis was conducted using linear regression and multilevel models, and adjusted for confounding variables. Results. Pre-operative. In knee patients, there was weak evidence that the effect of PPTs on pain severity was greater in patients with more severe OA compared to patients with less severe OA (Grade 3 OA: ß=0.96 vs Grade 4 OA: ß=4.03). However, in hip patients, the effect of PPTs on pain severity did not differ with the extent of radiographic OA (Grade 3 OA: ß=3.95 vs Grade 4 OA: ß=3.67). Post-operative. Patients undergoing TKR with less severe OA who had lower PPTs (greater widespread hyperalgesia) benefitted less from surgery than patients with higher PPTs (Grade 3 OA: ß=2.28). Conversely, patients undergoing THR with more severe OA who had lower PPTs benefited more from surgery than patients with higher PPTs (Grade 4 OA: ß=−2.92). Conclusion. Central sensitisation may be a determinant of how much patients benefit from joint replacement, but the effect varies by joint and severity of structural joint changes. Level of Evidence. 2. Approvals. The APEX trials were registered as an International Standardised Randomised Controlled Trial (96095682), approved by Southampton and South West Hampshire Research Ethics Committee (09/H0504/94) and all participants provided informed written consent

Objective. There is limited information about the extent to which the association between pre-operative and chronic post-operative pain is mediated via pain-on-movement or pain-at-rest. We explored these associations in patients undergoing total hip (THR) and total knee (TKR) replacement. Methods. 322 and 316 patients receiving THR and TKR respectively were recruited into in a single centre UK cohort (APEX) study. Pre-operative, acute post-operative and 12-month pain severity was measured using self-reported pain instruments. The association between pre-operative / acute pain and chronic post-operative pain was investigated using structural equation modelling (SEM). Results. Patients with high levels of pre-operative pain were more likely to report chronic pain after THR (β=0.195; p=0.02) and TKR (β=0.759; p<0.0001). Acute post-operative pain-on-movement was not associated with chronic pain after TKR or THR after adjusting for pre-operative pain, however acute pain-at-rest was associated with chronic pain after THR (β=0.20; p<0.0002) but not TKR after adjusting for pre-operative pain. Analysis of pain-at-rest and pain-on-movement highlighted differences between THR and TKR patients. Chronic pain after THR was weakly associated with pain-at-rest during the pre-operative (β=0.11; p=0.068) and acute post-operative period (β=0.21; p<0.0001). In contrast, chronic-pain after TKR was strongly associated with the severity of pain-on-movement during the pre-operative period (β=0.51; p=0.001). Conclusions. SEM illustrated the different patterns of association between measures of pain over time in patients undergoing THR and TKR for osteoarthritis. These findings highlight the importance of future work which explore the mechanisms underlying pain-on-movement and pain-at-rest. Level of Evidence. 2. Approvals. The APEX trials were registered as an International Standardised Randomised Controlled Trial (96095682), approved by Southampton and South West Hampshire Research Ethics Committee(09/H0504/94) and all participants provided informed written consent

Background. This article reviews four commonly used approaches to assess patient responsiveness to a treatment or therapy [Return To Normal (RTN), Minimal Important Difference (MID), Minimal Clinically Important Difference (MCID), OMERACT-OARSI (OO)], and demonstrates how each of the methods can be formulated in a multi-level modelling (MLM) framework. Methods. Data from the Arthroplasty Pain Experience (APEX) cohort study was used. Patients undergoing total hip and knee replacement completed the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire prior to surgery and then at 3, 6 and 12 months after surgery. We compare baseline scores, change scores, and proportion of individuals defined as “responders” using traditional and multi-level model (MLM) approaches to patient responsiveness. Results. Using existing approaches, baseline and change scores are underestimated, and the variance of baseline and change scores overestimated in comparison to MLM approaches. MLM increases the proportion of individuals defined as responding in RTN, MID, and OO criteria compared to existing approaches. Using MLM with the MCID criteria reduces the number of individuals identified as responders. Conclusion. MLM improves the estimation of the standard deviation of baseline and change scores by explicitly incorporating measurement error into the model, and avoiding regression to the mean when making individual predictions. Using refined definitions of responsiveness may lead to a reduction in misclassification when attempting to predict who does and does not respond to an intervention, and clarifies the similarities between existing methods. Approvals. The APEX trials were registered as an International Standardised Randomised Controlled Trial (96095682), approved by Southampton and South West Hampshire Research Ethics Committee (09/H0504/94) and all participants provided informed written consent