Aim. The SOLARIO trial is a
Aim. Rifampicin and fluoroquinolone based therapy is generally considered as first-choice targeted oral antimicrobial therapy for staphylococcal prosthetic joint infections (PJI) treated with debridement, antibiotics and implant retention (DAIR). Alternative equally effective antimicrobial strategies are urgently needed due to toxicity and drug-drug interactions that frequently occur with this strategy. Data from recent clinical studies suggests equipoise for other antimicrobial treatment regimens. The objective of the Rifampicin Combination Therapy versus Targeted Antimicrobial Monotherapy in the Oral Antimicrobial Treatment Phase of Staphylococcal Prosthetic Joint Infection (RiCOTTA)-trial is to evaluate whether monotherapy with clindamycin is non-inferior to rifampicin/fluoroquinolone combination therapy in patients with staphylococcal PJI that are treated with DAIR. Method. The RiCOTTA-trial is a multicenter, non-inferiority, open-label, randomized controlled trial evaluating clindamycin versus rifampicin/fluoroquinolone combination therapy in the oral treatment phase in patients with staphylococcal PJI managed with DAIR. The trial is performed in 16 hospitals in the Netherlands. Eligible patients are adults with staphylococcal knee or hip PJI managed by DAIR. Patients are included one to six days before antibiotic treatment is switched from intravenous to oral therapy. Patients with a contraindication for rifampicin, with a megaprosthesis or who receive intravenous antibiotics for more than three weeks after initial debridement are excluded. Primary outcome is treatment success one year after finishing antimicrobial treatment. Success is defined as the absence of: i. Infection related re-surgery, ii. New episode of antibiotic treatment for infection of the index joint after the initial treatment phase of 12 weeks, iii. Ongoing use of antibiotics for the index joint at the end of follow-up, iv. Death. The estimated treatment success of rifampicin combination therapy is 85% and the monotherapy strategy is considered not inferior when the difference in treatment success will be less than 10%. Enrolment of 158 patients per group (316 in total) is needed to confirm non-inferiority of monotherapy with a power of 80%. The trial is currently open for enrolment. The study is approved by the Medical Ethics Committee Leiden, the Hague, Delft, the Netherlands and registered under EU trial number 2022-501620-26-00 in Clinical Trial Information System. Conclusions. Currently, the RiCOTTTA study is the largest
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
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,
The direct superior approach (DSA) is a modification of the posterior approach (PA) that preserves the iliotibial band and short external rotators except for the piriformis or conjoined tendon during total hip arthroplasty (THA). The objective of this study was to compare postoperative pain, early functional rehabilitation, functional outcomes, implant positioning, implant migration, and complications in patients undergoing the DSA versus PA for THA. This study included 80 patients with symptomatic hip arthritis undergoing primary THA. Patients were prospectively
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
Background and study purpose. A recent systematic review with meta-analysis of eight
Background and Purpose. The UK's NIHR and Australia's NHMRC have funded two
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,
Background. Embodiment- and distraction-based approaches to immersive virtual reality (IVR) show promise in treating persistent low back pain (PLBP). However, which approach is more effective is unclear. This study aims to evaluate the impact of distraction- and embodiment-based IVR on pain processing and patient-reported outcome measures in PLBP. Method. Individuals with PLBP were
Purpose and Background. Guidelines recommend biopsychosocial care for chronic, complex musculoskeletal conditions, including non-specific low back pain. The aims were: 1/ to assess how patients with low back pain respond to osteopathic treatment, both before and after an osteopath has completed a Biopsychosocial Pain Management (BPM) course; and 2/ to assess if it is feasible and acceptable for osteopath participants to receive weekly SCED data and use it to guide patient management. Methods and Results. A multiple baseline single case experimental design trial (. clinicaltrials.gov. , on 18/10/2021, ID number NCT05120921) with 11 UK osteopaths was conducted. Patients were
Introduction. Unstable ankle fractures are routinely managed operatively. Due to soft-tissue and implant related complications, there has been recent literature reporting on the non-operative management of well-reduced medial malleolus fractures following fibular stabilisation, but with limited evidence supporting routine application. This trial assessed the superiority of internal fixation of well-reduced (displacement ≤2mm) medial malleolus fractures compared with non-fixation following fibular stabilisation. Methods and participants. Superiority, pragmatic, parallel, prospective
Background. Infiltration is considered the first treatment option for symptomatic Morton's neuroma and can be performed with various medications. The aim of this study was to compare the effects of hyaluronic acid infiltration versus corticosteroid injection in the treatment of Morton's neuroma. Methods. A
Background. The PATH-2 trial found no evidence of a benefit of Platelet Rich Plasma (PRP) injection versus a placebo after Achilles tendon rupture (ATR) at six-months. ATR often leave longer-term functional deficiencies beyond six-months. This study aim is to determine if PRP affect tendon functional outcomes at two-years after rupture. Study design. Randomised multi-centre two-arm parallel-group, participant- and assessor-blinded, superiority trial. Methods. Adults with acute ATR managed non-surgically were recruited in 19 UK hospitals from 2015 to 2019. Exclusions were insertion or musculotendinous injuries, leg injury or deformity, diabetes, haematological disorder, corticosteroids and anticoagulation therapy. Participants were
Introduction. Day stay surgery for anterior cruciate ligament (ACL) reconstructions is an increasingly common practice and has driven clinicians to come up with postoperative pain regimes that allow same day mobilisation and a safe and timely discharge. There is a paucity of literature surrounding the use of intraosseous (IO) ropivacaine used as a Bier's block to provide both intraoperative and postoperative analgesia in lower limb surgery. Methods. This patient blinded, pilot study
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
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
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
The primary treatment goal for patients with femoroacetabular impingement syndrome, a common hip condition in athletes, is to improve pain and function. In selected patients, in the short term following intervention, arthroscopic hip surgery is superior to a pragmatic NHS- type physiotherapy programme. Here, we report the three-year follow-up results from the FemoroAcetabular Impingement Trial (FAIT), comparing arthroscopic hip surgery with physiotherapy in the management of patients with femoroacetabular impingement (FAI) syndrome. Two-group parallel, assessor-blinded, pragmatic
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