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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_20 | Pages 14 - 14
12 Dec 2024
Kakwani M Pujol-Nicolas A Griffiths A Hutt N Townshend D Murty A Kakwani R
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Objectives. Minimally invasive surgery (MIS) has gained popularity for hallux valgus, compared to the traditional scarf osteotomy (OS). Though evidence suggests similar clinical outcomes, there is paucity of randomised controlled studies. This study aimed to assess the feasibility of conducting a randomised controlled trial comparing the patient recorded and clinical outcomes for the surgical management of Hallux Valgus between OS and MIS Chevron Akin (MICA). Methods. Patients suitable for surgical correction were invited to participate. Post-op rehabilitation was standardised for both groups. Patients completed a validated questionnaire (Manchester Oxford Foot questionnaire and EQ-5D-5L) pre-operatively and post-operatively at 6 months and 1 year. Radiological parameters and range of motion were measured pre-and post-operatively. Results. 31 patients were recruited between Dec 2017 and June 2022. 17 patients were randomised to MICA (15 female, mean age 51) and 15 to OS (14 female, mean age 51). Both groups had a significant improvement in all MOXFQ parameters at 6m and 12m, as well as radiological parameters. VAS improved for OS (p=0.048) and for MICA (p=0.059) at 6m. There was no significant improvement in EQ-5D in either group at 12 months and no significant difference in operative time (p=0.53). There was a higher number of complications in the MICA group with 5 removal of metalwork (29.4%) and 2 superficial infections (11.8%) versus none in the OS group. The dorsiflexion significantly improved in the OS group at 6months (p=0.04). Recruitment rate dipped during COVID. No patients were lost at follow up. Conclusion. Both surgical options show similar clinical results, but higher complication rates were seen with MICA. This study illustrates the feasibility to conduct a randomised control trial for the comparison between the two techniques. Challenges to recruitment included surgeon equipoise, patient preference, training requirement and the pandemic which could be mitigated in a larger study


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_18 | Pages 75 - 75
14 Nov 2024
Khalid T Shlomo YB Bertram W Culliford L enderson E Jepson M Johnson E Palmer S Whitehouse M Wylde V
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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


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_16 | Pages 30 - 30
19 Aug 2024
Timperley AJ
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The SPAIRE technique (Saving Piriformis And Internus, Repair Externus) was first described in 2016 and an approach to the hip in the interval between the inferior gemellus and quadratus femoris can be used for both hemi- and total hip arthroplasty. The HemiSPAIRE technique in hip hemiarthroplasty for displaced intracapsular fractures has been compared with the standard lateral approach (advocated by NICE) in a pragmatic, superiority, multicentre, randomised controlled trial into postoperative mobility and function. This NIHR funded study was recruited between November 2019 and April 2022 and the results are reported in this presentation. The author has used the SPAIRE technique in 1026 routine primary total hip replacements since February 2016. The technique is described along with results from NJR data. SPAIRE is most challenging in patients with small anatomy, reduced offset, with an external rotation deformity. Particularly in these, but in all cases, MAKO robotic assistance facilitates accurate implantation of prostheses and precise recreation of biomechanics. The MAKO robot has been used in all cases since 2018 and SPAIRE/MAKO is now the standard of care in the author's practice. To evaluate whether robotic-assisted tendon-sparing posterior approaches (piriformis sparing and SPAIRE), improve patient outcomes in total hip arthroplasty compared with a robotic-assisted standard posterior approach, the NIHR Efficacy and Mechanism Evaluation Programme has recently funded the HIPSTER trial (HIP Surgical Techniques to Enhance Rehabilitation). This is a single-centre, double-blinded, parallel three-arm, randomised, controlled, superiority trial; recruitment is in progress. The greatest value of robotic assistance may be when it is used in combination with tendon-sparing surgery. Data is being gathered to evaluate whether the SPAIRE/MAKO technique confers benefits with regard the speed of post-op mobilisation as well as accelerated return to unrestricted function


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_15 | Pages 30 - 30
7 Aug 2024
Preece S Smith J Brookes N Ghio D
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Purpose. Cognitive Muscular Therapy (CMT) is a new treatment for low back pain which integrates psychological techniques for pain management alongside training to improve postural control. Rather than focus on postural alignment or strength, CMT aims to improve the regulation of postural tone (low-level activity which supports the body against gravity). This is achieved by teaching patients an awareness of compensatory paraspinal activation, which can be triggered by overactivity of the abdominal muscles. The aim of this study was to understand whether CMT could reduce symptoms associated with low back pain and improve paraspinal muscle activation. Methods and results. Fifteen patients with chronic low back pain received seven weekly sessions of CMT from a physiotherapist. Clinical data was captured at baseline and two weeks after the intervention using the Roland-Morris questionnaire and the pain catastrophising scale. Activation of the erector spinae muscle during walking was also measured at baseline and after the final intervention session. Change data were analysed using paired t-tests. There was a 75% reduction (p<0.001) in the Roland-Morris score from a mean (SD) of 9.3(2.9) to 2.3(2.6), along with a 78% reduction in pain catastrophising (p<0.002) from 16.6(13) to 3.7(4.8). Activation of the contralateral erector spinae muscles reduced by 30% (p<0.01) during the contralateral swing phase of walking. Conclusion. In this small sample, CMT delivered large clinical improvements and reduced activation of the low back muscles during walking. Larger randomised trials are now required to confirm whether CMT could outperform existing physiotherapy treatments for chronic back pain. Conflict of interest. No conflicts of interest. Source of funding. University of Salford


Background and study purpose. A recent systematic review with meta-analysis of eight randomised controlled trials concluded that Cognitive Functional Therapy (CFT) for low back pain might be effective in reducing disability, pain and fear-avoidance beliefs. However, the descriptions of a CFT intervention are not always clear. This study aimed to rate the replicability of the CFT interventions and control groups in the systematic review. Methods. Two reviewers independently extracted data from the study articles, protocols and appendices into Microsoft Excel using the Template for Intervention Description and Replication (TIDieR) checklist. This checklist has 12 items to describe the ‘why’, ‘what’, ‘who’, ‘how’, ‘where’, ‘when and how much’, ‘tailoring’, ‘modifications’, and ‘how well’ for each intervention. We rated the replicability of the CFT interventions and control groups as ‘reported’, ‘partially reported’ and ‘not reported’ and resolved discrepancies by consensus. Results. No studies reported 100% of the TIDieR items; the mean ‘reported’ rating was 54% (range 33–67%) for the CFT interventions and 35% (range 8–67%) for controls. The six most replicable items were the same for both CFT and control groups. These were ‘brief name’ (CFT=100%; control=100%), ‘why’ (CFT=100%; control=50%), ‘how’ (CFT=100%; control=50%), ‘what procedures’ (CFT=88%; control=63%), ‘where’ (CFT=88%; control=75%) and ‘planned adherence’ (CFT=75%; control=38%). Items that were not sufficiently ‘reported’ for either CFT or control groups included ‘when and how much’, ‘tailoring’ and ‘adherence’. Conclusion. Incomplete descriptions of CFT interventions mean that clinicians and patients cannot implement those that have demonstrated effectiveness, and poor descriptions of control groups prevent researchers from replicating them in future studies. Conflict of interest. No conflicts of interest. Sources of funding. No funding obtained


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_15 | Pages 19 - 19
7 Aug 2024
Foster NE Bada E Window P Stovell M Ahuja S Beard D Gardner A
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Background and Purpose. The UK's NIHR and Australia's NHMRC have funded two randomised controlled trials (RCTs) to determine if lumbar fusion surgery (LFS) is more effective than best conservative care (BCC) for adults with persistent, severe low back pain (LBP) attributable to lumbar spine degeneration. We aimed to describe clinicians’ decision-making regarding suitability of patient cases for LFS or BCC and level of equipoise to randomise participants in the RCTs. Methods. Two online cross-sectional surveys distributed via UK and Australian professional networks to clinicians involved in LBP care, collected data on clinical discipline, practice setting and preferred care of five patient cases (ranging in age, pain duration, BMI, imaging findings, neurological signs/symptoms). Clinicians were also asked about willingness to randomise each patient case. Results. Of 174 responses (73 UK, 101 Australia), 70 were orthopaedic surgeons, 34 neurosurgeons, 65 allied health professionals (AHPs), 5 others. Most worked in public health services only (92% UK, 45% Australia), or a mix of public/private (36% Australia). Most respondents chose BCC as their first-choice management option for all five cases (81–93% UK, 83–91% Australia). For LFS, UK surgeons preferred TLIF (36.4%), whereas Australian surgeons preferred ALIF (54%). Willingness to randomise cases ranged from 37–60% (UK mean 50.7%), and 47–55% (Australian mean 51.9%); orthopaedic and neuro-surgeons were more willing than AHPs. Conclusion. Whilst BCC was preferred for all five patient cases, just over half of survey respondents in both the UK and Australia were willing to randomise cases to either LFS or BCC, indicating clinical equipoise (collective uncertainty) needed for RCT recruitment. Conflicts of interest. None. Sources of funding. No specific funding obtained for the surveys. DB, SA, AG and NEF have funding from the National Institute for Health Research (NIHR) UK (FORENSIC-UK NIHR134859); NEF, DB and SA have funding from the Australian National Health and Medical Research Council (NHMRC FORENSIC-Australia GA268233). AG has funding from Orthopaedic Research UK (combined with British Association of Spine Surgeons and British Scoliosis Society) and Innovate UK. NEF is funded through an Australian National Health and Medical Research Council (NHMRC) Investigator Grant (ID: 2018182)


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_15 | Pages 37 - 37
7 Aug 2024
Wilson M Cole A Hewson D Hind D Hawksworth O Hyslop M Keetharuth A Macfarlane A Martin B McLeod G Rombach I Swaby L Tripathi S Wilby M
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Background. Over 55,000 spinal operations are performed annually in the NHS. Effective postoperative analgesia facilitates early mobilisation and assists rehabilitation and hospital discharge, but is difficult to achieve with conventional, opioid-based, oral analgesia. The clinical and cost-effectiveness of two alternative techniques, namely intrathecal opioid and the more novel erector-spinae plane blockade, is unknown. The Pain Relief After Instrumented Spinal Surgery (PRAISE) trial aims to evaluate these techniques. Methods. PRAISE is a multicentre, prospective, parallel group, patient-blinded, randomised trial, seeking to recruit 456 adult participants undergoing elective, posterior lumbar-instrumented spinal surgery from up to 25 NHS hospitals. Participants will be randomised 1:1:1 to receive (1) Usual Care with local wound infiltration, (2) Intrathecal Opioid plus Usual Care with local wound infiltration or (3) Erector Spinae Plane blockade plus Usual Care with no local wound infiltration. The primary outcome is pain on movement on a 100mm visual analogue scale at 24 hours post-surgery. Secondary outcomes include pain at rest, leg pain, quality of recovery (QoR-15), postoperative opioid consumption, time to mobilisation, length of hospital stay, health utility (EQ-5D-5L), adverse events and resource use. Parallel economic evaluation will estimate incremental cost-effectiveness ratios. Results. Differences in the primary outcome at 24 hours will be estimated by mixed-effects linear regression modelling, with fixed effects for randomisation factors and other important prognostic variables, and random effects for centre, using the as-randomised population. Treatment effects with 95% confidence intervals will be presented. Conclusion. The study is due to open in May 2024 and complete in 2026. Conflicts of Interest. No conflicts of interest declared. Sources of Funding. NIHR Health Technology Award – grant number NIHR153170. Trial presentations so far. APOMP 2023 and 2024; RCOA conference, York, November 2023; Faculty of Pain Management training day, London, February 2024


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_8 | Pages 12 - 12
10 May 2024
Sevic A Patel C Tomlinson M
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Introduction. Comparative studies examining Fixed-Bearing (FB) and Mobile-Bearing (MB) Total Ankle Replacement (TAR) designs have demonstrated similar results and successful long-term outcomes for both. To date there has been no study directly comparing FB and MB designs of the same prosthesis. We present the first prospective randomised trial comparing patient satisfaction, functional outcomes and radiographic results of the Salto Talaris Fixed-Bearing and the Salto Mobile-Bearing Total Ankle Replacement in the treatment of end-stage ankle arthritis. Methods. A total of 108 adult patients with end-stage ankle arthritis were enrolled in the study between November 2014 and October 2021 with similar demographic comparison. Prospective patient-reported outcomes and standardised weightbearing ankle radiographs were performed preoperatively, at 6 weeks, 6 months and 12 months post-operatively, followed by yearly intervals. All surgeries were performed by a single non-design orthopaedic foot and ankle specialist with experience in over 200 Salto and Salto Talaris TAR prior to the study. Radiographs were examined independently by two clinicians. Complete patient data and radiographs were available for 103 patients with an average follow up of 2 years. Results. Both groups demonstrated statistically significant improvement from preoperative evaluation to most recent follow up with no statistically significant difference between the two groups in all outcome measures. Radiographic incidence of subchondral cyst formation was 8.9% and 38.2% for FB and MB, respectively. Talar subsidence occurred in 2.2% and 5.5% of FB and MB, respectively. Discussion. Our study demonstrates a higher than previously reported rate of cyst formation in the MB TAR and comparatively higher talar subsidence in the MB TAR vs FB however this did not correlate with clinical outcome measures which were favourable for both groups. Conclusion. Fixed-Bearing and Mobile-Bearing Total Ankle Replacement demonstrate comparable favourable


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_8 | Pages 23 - 23
10 May 2024
Leary J Lynskey T Muller A
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Objective. Carpal tunnel release surgery is a commonly performed procedure for alleviating symptoms of median nerve compression and restoring hand function. With pressure on theatre time these procedures are now commonly performed in a step-down out-patient facility under local anaesthetic. The choice of suture for skin closure in this procedure can impact the quality of wound healing, patient outcomes and the follow-up required however the question of the best type of suture remains unanswered. The purpose of this study was to compare the outcomes of absorbable and non-absorbable sutures using a randomised control trial design. Methods. Eighty patients diagnosed with bilateral carpal tunnel syndrome were enrolled and underwent outpatient carpal tunnel release surgery under local anaesthetic in a staged fashion. Random number generation was used to assign each hand to receive interrupted nylon or Vicryl Rapide sutures. Pre-operative data collection included patient demographics, ASA, inflammatory conditions, smoking status as well as a Boston Carpal Tunnel Questionnaire (BCTQ) for each hand. Patients were followed up at 2 and 6 weeks after each operation and the BCTQ was repeated along with the Patient and Observer Scar Assessment Scale and the VAS score for wound discomfort. This study has approval from the DHB ethics committee, Local Iwi, HDC and ANZ Clinical Trials:ACTRN12623000100695. Results. Statistical analysis assessed patient preference and the scores between the groups. Multi-variate analysis was performed to assess the factors that may be contributing to patient choice. Conclusion. Insights into patient preference and clinical outcomes associated with absorbable sutures and non-absorbable sutures in the setting of out-patient surgery are discussed


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_6 | Pages 29 - 29
2 May 2024
Gibbs V Champaneria R Sandercock J Welton N Geneen L Brunskill S Doree C Kimber C Palmer A Estcourt L
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Preoperative anaemia and intraoperative blood loss result in ∼90% of individuals being anaemic following hip and knee arthroplasty. Reducing blood loss offers the opportunity to improve outcomes and reduce the risk of transfusion and costs. This review's aim was to determine the effectiveness of drugs for preventing blood loss, and identify optimal dose, route, and timing of administration. Cochrane network meta-analysis of randomised controlled trials was conducted. Inclusion criteria: adults undergoing primary or revision elective hip or knee arthroplasty. Drugs studied: tranexamic acid (TXA), aprotinin, epsilon-aminocaproic acid, desmopressin, factor VIIa and XIII, fibrinogen, fibrin sealants, and non-fibrin sealants. Primary outcomes: need for allogenic blood transfusion, all• cause mortality (within 30 days). Secondary outcomes: mean number of transfusion episodes, re-operation, length of hospital stay and adverse events (DVT, PE, CVA, MI). 102 studies with 8418 participants. Trials included more women (63%). 47 studies (4398 participants) were included within the blood transfusion NMA. TXA given intra-articularly and orally at a total dose of greater than 3g pre-incision, intraoperatively and postoperatively ranked the highest, with anticipated absolute effect of 147 fewer transfusions per 1000 (53% chance ranking 1st) (relative risk(RR) 0.02, 95% credible interval(CrI) 0–0.31); moderate-certainty). Aprotinin (RR 0.59, 95%:CrI 0.36–0.86; low certainty evidence), fibrin (RR 0.86, CrI 0.25–2.93; very-low certainty) and EACA (RR 0.60, 95%:CrI 0.29–1.27; very-low certainty) were not shown to be as effective as TXA. TXA was the most effective drug for preventing bleeding in lower limb arthroplasty. Aprotinin and EACA were not as effective. Currently, the optimal dose, route and timing of administration of TXA is unclear. However, TXA given at higher doses and via mixed routes ranked higher in the treatment hierarchy. Oral TXA may be as effective as intavenous. There was no evidence of harm associated with higher doses of TXA


Total hip replacement (THR) is one of the most common and cost-effective elective surgical procedures. In the National Health Service (NHS) of England and Wales a myriad of implants for THR are offered at a variety of locally negotiated prices. This study aims to estimate the total burden of elective THR to the NHS, expenditure on implants, and different scenarios of cost changes if implant selection changed for different patient groups. Using National Joint Registry (NJR) data and NHS reference costs, we estimated the number and expenditure of NHS funded primary and revision THR in the 10-year period 2008–2017 and forecasted the number and expenditure on THR over the next decade. Using NJR average NHS Trust prices for the different implant combinations we estimated the average cost of implants used in THRs and estimated the budget impact on NHS providers from switching to alternative implants. The NHS spent over £4.76 billion performing 702,381 THRs between 2008–2017. The average cost of implants was £1,260 per surgery, almost a fifth of the cost of primary THR. Providing cemented implant combinations in primary elective THRs may potentially save up to £281 million over the next 10 years, whilst keeping 10-year revision risks low. The NHS is likely to spend over £5.6 billion providing primary elective THR over the next decade. There are efficiency savings to realise in the NHS by switching to more cost-effective implant combinations available for patients undergoing primary elective THR surgery, but these will need to be balanced against the risks inherent to a change in selection of implants and surgical practice. The HIPPY programme will be conducting practice surveys, discrete choice experiments and a large randomised controlled trial of cemented, uncemented and hybrid fixation in THR for patients under 70 to answer uncertainties


Bone & Joint Open
Vol. 5, Issue 3 | Pages 162 - 173
4 Mar 2024
Di Mascio L Hamborg T Mihaylova B Kassam J Shah B Stuart B Griffin XL

Aims

Is it feasible to conduct a definitive multicentre trial in community settings of corticosteroid injections (CSI) and hydrodilation (HD) compared to CSI for patients with frozen shoulder? An adequately powered definitive randomized controlled trial (RCT) delivered in primary care will inform clinicians and the public whether hydrodilation is a clinically and cost-effective intervention. In this study, prior to a full RCT, we propose a feasibility trial to evaluate recruitment and retention by patient and clinician willingness of randomization; rates of withdrawal, crossover and attrition; and feasibility of outcome data collection from routine primary and secondary care data.

Methods

In the UK, the National Institute for Health and Care Excellence (NICE) advises that prompt early management of frozen shoulder is initiated in primary care settings with analgesia, physiotherapy, and joint injections; most people can be managed without an operation. Currently, there is variation in the type of joint injection: 1) CSI, thought to reduce the inflammation of the capsule reducing pain; and 2) HD, where a small volume of fluid is injected into the shoulder joint along with the steroid, aiming to stretch the capsule of the shoulder to improve pain, but also allowing greater movement. The creation of musculoskeletal hubs nationwide provides infrastructure for the early and effective management of frozen shoulder. This potentially reduces costs to individuals and the wider NHS perhaps negating the need for a secondary care referral.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_4 | Pages 4 - 4
8 Feb 2024
Oliver WM Bell KR Carter TH White TO Clement ND Duckworth AD Molyneux SG
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This single-centre prospective randomised trial aimed to assess the superiority of operative fixation compared with non-operative management for adults with an isolated, closed humeral shaft fracture. 70 patients were randomly allocated to either open reduction and internal fixation (51%, n=36/70) or functional bracing (49%, n=34/70). 7 patients did not receive their assigned treatment (operative n=5/32, non-operative n=2/32); results were analysed based upon intention-to-treat. The primary outcome measure was the DASH score at 3 months. Secondary outcomes included treatment complications, union/nonunion, shoulder/elbow range of motion, pain and health-related quality of life (HRQoL). At 3 months, 66 patients (94%) were available for follow-up; the mean DASH favoured surgery (operative 24.5, non-operative 39.4; p=0.006) and the difference (14.9 points) exceeded the MCID. Surgery was also associated with a superior DASH at 6wks (operative 38.4, non-operative 53.1; p=0.005) but not at 6 months or 1yr. Brace-related dermatitis affected 7 patients (operative 3%, non-operative 18%; OR 7.8, p=0.049) but there were no differences in other complications. 8 patients (11%) developed a nonunion (operative 6%, non-operative 18%; OR 3.8, p=0.140). Surgery was associated with superior early shoulder/elbow range of motion, and pain, EuroQol and SF-12 Mental Component Summary scores. There were no other differences in outcomes between groups. Surgery confers early advantages over bracing, in terms of upper limb function, shoulder/elbow range of motion, pain and HRQoL. However, these benefits should be considered in the context of potential operative risks and the absence of any difference in patient-reported outcomes at 1yr


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_18 | Pages 1 - 1
1 Dec 2023
Osmani H Nicolaou N Anand S Gower J Metcalfe A McDonnell S
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Introduction. The knee is the most commonly injured joint in sporting accidents, leading to substantial disability, time off work and morbidity (1). Treatment and assessment vary around the UK (2), whilst there remains a limited number of high-quality randomised controlled trials assessing first time, acute soft tissue knee injuries (3,4). As the clinical and financial burden rises (5), vital answers are required to improve prevention, diagnosis, treatment, rehabilitation, and delivery of care. In association with the James Lind Alliance, this BASK, BOSTAA and BOA supported prioritising exercise was undertaken over a year. Methods. The James Lind Alliance methodology was followed; a modified nominal group technique was used in the final workshop. An initial survey invited patients and healthcare professionals to submit their uncertainties regarding soft tissue knee injury prevention, diagnosis, treatment, rehabilitation, and delivery of care. Seventy-four questions were formulated to encompass common concerns. These were checked against best available evidence. Following the interim survey, 27 questions were taken forward to the final workshop in January 2023, where they were discussed, ranked, and scored in multiple rounds of prioritisation by groups of healthcare professionals, patients, and carers. Results. Over 1000 questions were submitted initially. Twenty-seven were taken forward to the final workshop following the surveys. Nearly half of the responses were from patients/carers. The Top 10 (Figure 1) includes prevention, diagnosis, treatment, and rehabilitation questions, reflecting the concerns of patients, carers, and a wider multidisciplinary team. Conclusion. This validated process has generated an important, wide- ranging Top 10 priorities for future soft tissue knee injury research. These have been submitted to the National Institute for Health and Care Research and are now available for researchers to investigate. The final 27 questions which were taken to the final workshop have also been published on the James Lind Alliance website. Research into these questions will lead to future high-quality research, thus improving patient care & outcomes. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 28 - 28
7 Aug 2023
Bertram W Wylde V Glynn J Penfold C Burston A Johnson E Rayment D Howells N White S Gooberman-Hill R Whale K
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Abstract. Introduction. There is a need to develop approaches to reduce chronic pain after total knee replacement. There is an established link between disturbed sleep and pain. We tested the feasibility of a trial evaluating the clinical and cost-effectiveness of a pre-operative sleep assessment and complex intervention package for improving long-term pain after TKR. Methodology. REST was a feasibility multi-centre randomised controlled trial with embedded qualitative study and health economics. Participants completed baseline measures and were randomised to usual care or the intervention, a tailored sleep assessment and behavioural intervention package delivered by an extended scope practitioner three months pre-operatively with a follow-up call up at four-weeks. Patient reported outcomes were assessed at baseline, one-week pre-surgery, and 3-months post-surgery. Results. 57 patients were randomised and 20 had surgery within the study timelines. All patients allocated the intervention attended an appointment and most engaged with treatment. The intervention group reported improvements in sleep (Sleep Conditions Indicator) and neuropathic pain (painDETECT) scores. Participants found the sleep treatments and study processes to be acceptable. The mean cost of the intervention was estimated at £134.45 per patient. Conclusion. The feasibility study has shown that patient recruitment is feasible, engagement with and adherence to the intervention is high, and the intervention is acceptable to patients and clinicians. Preliminary findings show that the intervention group had improved sleep quality and had reduced levels of pre-operative neuropathic pain. This study has demonstrated that a full RCT is feasible and identified areas for improvement to optimize the trial design


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 50 - 50
7 Aug 2023
Bertram W Wylde V Howells N Shirkey B Peters T Zhu L Noble S Moore A Beswick A Judge A Blom A Walsh D Eccleston C Bruce J Gooberman-Hill R
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Abstract. Introduction. Approximately 15–20% of patients report chronic pain three months after total knee replacement (TKR). The STAR care pathway is a clinically important and cost-effective personalised intervention for patients with pain 3 months after TKR. The pathway comprises screening, assesment, onward referral for treatment and follow-up over one year. In a multicentre randomised controlled trial comparing the pathway with usual care, the pathway improved pain at 6 and 12 months. This study examined the longer-term clinical and cost-effectiveness of the STAR care pathway. Methodology. STAR trial participants were followed-up at a median of 4 years post-randomisation. Co-primary outcomes were self-reported pain severity and interference in the replaced knee, assessed with the Brief Pain Inventory (BPI). Resource use from electronic hospital records was valued with UK reference costs. Results. Of the 337 participants active at trial completion, 326 had confirmed vital status, and 226 (69%) provided outcome data at a median of 4 years. The between-group difference in mean BPI severity score was −0.42 (95% CI −1.07, 0.23; p=0.20) and for BPI interference was −0.64 (95% CI −1.41, 0.12; p=0.10), favouring the intervention. Multiple imputation analyses led to attenuations of about 0.2 points. Mean hospital admission costs over four years were £2461.49 (95% CI £1354.42, £3568.57) in the intervention arm and £3791.68 (95% CI £2095.12, to £5488.24) in usual care. Conclusion. These data are consistent with sustained benefits from the STAR care pathway at 4 years, albeit attenuated and with wider confidence intervals, in part attributable to attrition after 1 year


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 11 - 11
7 Aug 2023
Khalid T Ben-Shlomo Y Bertram W Culliford L England C Henderson E Jameson C Jepson M Palmer S Whitehouse M Wylde V
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Abstract. Introduction. Frailty is associated with poorer outcomes after joint replacement. Targeting frailty pre-operatively via protein supplementation and exercise has the potential to improve outcomes after joint replacement. Before conducting a randomised controlled trial (RCT), a feasibility study is necessary to address key uncertainties and explore how to optimise trial design. Methodology. Joint PREP is a feasibility study for a multicentre, two-arm, parallel group, pragmatic, RCT to evaluate the clinical and cost-effectiveness of prehabilitation for frail patients undergoing total hip or knee replacement. Sixty people who are ≥65 years of age, frail and scheduled to undergo total hip or knee replacement at 2–3 NHS hospitals will be recruited and randomly allocated on a 1:1 ratio to the intervention or usual care group. The intervention group will be given a daily protein supplement and will be asked to follow a home-based, tailored daily exercise programme for 12 weeks before their operation, supported by fortnightly telephone calls from a physiotherapist. Embedded qualitative research with patients will explore their experiences of participating, reasons for non-participation and/or reasons for withdrawal or treatment discontinuation. Results. Outcomes to be assessed include eligibility, recruitment and retention rates; intervention adherence; acceptability of the trial and intervention; and data completion. Data collection is ongoing. Discussion. This study will generate important data regarding the feasibility of a RCT to evaluate a prehabilitation intervention for frail patients undergoing joint replacement. A future RCT will contribute to the evidence on interventions to optimise the benefit that frail patients gain from joint replacement


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 89 - 89
7 Aug 2023
Ahmed I Dhaif F Bowes M Parsons N Hutchinson C Staniszewska S Price A Metcalfe A
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Abstract. Introduction. Previous research has demonstrated no clinically significant benefit of arthroscopic meniscectomy in patients with a meniscal tear, however, patients included in these studies would not meet current treatment recommendations. Prior to further randomised controlled trials (RCTs) research is needed to understand a younger population in more detail. Aim. To describe the baseline characteristics of patients with a meniscal tear and explore any association between baseline characteristics and outcome. Methodology. A prospective, national multicentre cohort study was performed recruiting patients aged 18 to 55 presenting to secondary care. MRI analysis of arthritis was performed using Whole Organ Magnetic Resonance Imaging Score (WORMS) and bone shape analysis. Outcomes included the Western Ontario Meniscal Evaluation Tool (WOMET) and Knee Injury and Osteoarthritis Outcome Score (KOOS4) at 12 months. Results. 150 participants were recruited across eight sites with a mean age of 43.47 (SD 9.63). MRI analysis using WORMS score and bone shape analysis revealed no or early osteoarthritis. At 12 months, 67 (44.67%) of participants were managed non-operatively and 68 (45.33%) were operatively. Participants in the operative group were significantly younger with a lower BMI (p<0.05). A stepwise logistic regression model including 17 characteristics revealed that only baseline score and surgery significantly affected 12-month WOMET and KOOS4. Conclusion. This study in contrast to previous trials demonstrated a benefit of surgery for patients with a meniscal tear. The METRO study demonstrates that it is feasible to recruit younger patients and a future RCT is required using the study population included in this cohort


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 12 - 12
7 Aug 2023
Osmani H Nicolaou N Anand S Metcalfe A McDonnell S
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Abstract. Introduction. The knee is the most commonly injured joint in sporting accidents. They cause substantial disability, time off work and long-term problems. There remains a limited number of high-quality randomised controlled trials assessing first time, acute soft tissue knee injuries. Key areas requiring answers include prevention, diagnosis, treatment, rehabilitation and delivery of care. In association with the James Lind Alliance, this BASK, BOSTAA and BOA supported prioritising exercise was undertaken over a year. Methodology. The James Lind Alliance methodology was followed. An initial survey invited patients and healthcare professionals to submit their uncertainties regarding soft tissue knee injury prevention, diagnosis, treatment, rehabilitation and delivery of care. Over 1000 questions were submitted. Seventy-four questions were formulated to encompass common concerns. These were checked against best available evidence. Following the interim survey, 27 questions were taken forward to the final workshop in January 2023, where they were discussed, ranked and scored in multiple rounds of prioritisation by groups of healthcare professionals, patients and carers. Results. The Top 10 includes prevention, diagnosis, treatment and rehabilitation questions, reflecting the concerns of patients, carers and a wider multidisciplinary team. These will be presented and explained. Conclusion. This validated process has generated an important Top 10, which has been submitted to the National Institute for Health and Care Research. All 27 questions will be published, thus being available for researchers to investigate. The questions in the Top 10 will lead to future high quality research, thus improving patient outcomes


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_11 | Pages 12 - 12
7 Jun 2023
Qayum K Ng Z Sudarshan V Kudhail K Sapra H Guerero D Daoub A
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Patients undergoing total hip or knee arthroplasty (THA/TKA) are commonly associated with high pain scores and narcotic use. Duloxetine is effective in relieving chronic pain. The aim of this study was to evaluate the safety and efficacy of duloxetine for pain management following THA/TKA. Five major databases (PubMed, Embase, Scopus, Cochrane, and Web of Science) were searched for randomised controlled trials (RCTs) that compared duloxetine to placebo in patients that underwent THA/TKA. The primary outcome was pain reduction with rest and movement at short-term and long-term time intervals. Secondary outcomes were the use of analgesics, length of stay, and safety profile. The risk of bias was assessed using the Cochrane tool. Data were pooled using RevMan 5.4. The results were reported as mean difference (MD) or standardised MD (SMD) and 95% confidence intervals (CI). Eight RCTs with 767 patients were included. 50.2% (n=385/767) of patients received duloxetine. After one day, duloxetine was superior to the control regarding pain reduction with rest (SMD= −0.22 [−0.41, −0.03], p=0.02) after sensitivity analysis and pain reduction at movement (SMD= −0.39 [−0.55, −0.24], p<0.001). Similarly, after 12 weeks, duloxetine significantly reduced pain with rest (SMD= −0.3 [−0.52, −0.09], p=0.006) and pain with movement (SMD= −0.52 [−0.87, −0.17], p=0.003). In addition, after sensitivity analysis, duloxetine was associated with less analgesic use after one day (MD= −4.65 [−7.3, −2.01], p<0.001) and two days (MD= −5.65 [−10.62, −0.67], p=0.03). Patients who received duloxetine also required fewer analgesics after three days. However, there was no significant difference between the duloxetine and control groups in analgesic use after one week, length of stay, and adverse events. Duloxetine was superior to the placebo regarding short-term and long-term pain reduction with rest and movement following THA/TKA. Duloxetine reduced postoperative analgesic use. There was no significant difference between duloxetine and placebo regarding adverse events and length of stay