This study aims to evaluate the effectiveness of a pre-formulated irrigation solution1 (containing ethanol, acetic acid, sodium acetate, benzalkonium chloride, and sterile water) compared to saline solution in managing acute periprosthetic joint infections (A-PJI) during Debridement, Antibiotic, and Implant Retention (DAIR) surgeries. The primary objective is to assess the healing rate using this solution1 versus saline in A-PJI patients, with “cure” defined by a set of criteria including no recurrence, wound issues, or need for ongoing suppressive antibiotics after 1 year. Principio del formularioFinal del formulario This single-center, randomized controlled trial will involve patients with acute periprosthetic infections undergoing standard DAIR surgery, divided into two groups: one receiving saline solution and the other receiving pre-formulated solution1. The study is single-blinded, with patients unaware of their group assignment. The study is registered at ISRCTN: https://doi.org/10.1186/ISRCTN10873696. Inclusion criteria include patients over 18 with hip or knee prostheses suffering from acute or hematogenous periprosthetic infections, while exclusion criteria include a history of prior debridement or multiple infected implants, among others. Principio del formularioFinal del formulario A total of 50 subjects are needed for statistical significance, with a 5% dropout rate anticipated. An interim safety analysis will assess early effectiveness and adverse effects, and the results are presented in this study. Data will be managed in online databases and analyzed using SPSS software, with a significance level of p<0.05Aim
Method
Periprosthetic joint infection (PJI) is a severe complication after total joint arthroplasty. To prevent PJI, strict infection prevention measures are followed in combination with surgical antibiotic prophylaxis (SAP). To date, scientific reports concerning the optimal duration of SAP in revision arthroplasty are scarce. The aim of this multicenter open-label, randomized controlled trial in the Netherlands, is to investigate the superiority of 5 days (extended) versus a single dose of cefazolin to prevent PJI within the first year after revision arthroplasty of the hip and knee. Included patients with an assumed aseptic hip or knee revision procedure received a single dose of 2 or 3 gram cefazolin preoperatively. Patients were randomly assigned in a 1:1 ratio to receive extended prophylaxis of cefazolin during 5 days postoperatively versus no prophylaxis after wound closure. Patients were excluded if evidence of PJI at revision. The primary endpoint was the incidence of PJI within one year after revision arthroplasty. PJI was defined according to the 2018 Philadelphia consensus criteria. With a sample size of 746 patients, an alpha of 5% and a power of 80%, superiority of the extended regimen would be shown if the lower boundary of the 95% confidence interval (CI) of the absolute between-group difference of the percentage of PJI is below −4%.Aim
Method
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. 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.Introduction
Method
Exercise is recommended as first-line treatment for patients with hip osteoarthritis (OA). Interestingly, content and dose of exercise interventions seem to be important for the effect of exercise interventions, but the optimal content and dose is unknown. This warrants randomized controlled trials providing evidence for the optimal exercise program in Hip OA. The aim of this trial was to investigate whether progressive resistance training (PRT) is superior to neuromuscular exercise (NEMEX) for improving functional performance, hip pain and hip-related quality of life in patients with hip OA. This was a multicenter, cluster-randomized, controlled, parallel-group, assessor-blinded, superiority trial. 160 participants with clinically diagnosed hip OA were recruited from hospitals and physiotherapy clinics and randomly assigned to twelve weeks of PRT or NEMEX. The PRT intervention consisted of 5 high-intensity resistance training exercises targeting muscles at the hip and knee joints. The NEMEX intervention included 10 exercises and emphasized sensorimotor control and functional stability. The primary outcome was change in the 30-second chair stand test (30s-CST). Key secondary outcomes were changes in scores on the pain and hip-related quality of life (QoL) subscales of the Hip Disability and Osteoarthritis Outcome Score (HOOS).Introduction
Method
There is a lack of evidence-based treatments for patients with chronic pain after total knee arthroplasty (TKA). It is well-established that knee extensor and flexor muscle strength are markedly impaired following TKA, but no studies have examined muscle strength and power in patients with chronic pain after TKA. Therefore, the aim was to investigate if neuromuscular exercises and pain neuroscience education (PNE) were superior to PNE alone for improvement of muscle strength and power in patients with chronic pain after TKA. This report presents the exploratory analysis of a randomized controlled trial (NCT03886259). Participants with chronic moderate-to-severe average daily pain intensity and no signs of prosthesis failure at least one year after primary TKA were included. Participants were randomized to receive either supervised neuromuscular exercise and PNE or the same PNE sessions alone. The outcomes were changes from baseline to 12-months for peak leg extension power and maximum muscle strength, measured during maximal voluntary isometric contractions, for the knee extensors and flexors.Introduction
Method
The aims were to assess whether joint-specific outcome after total knee arthroplasty (TKA) was influenced by implant design over a 12-year follow-up period, and whether patient-related factors were associated with loss to follow-up and mortality risk. Long-term follow-up of a randomized controlled trial was undertaken. A total of 212 patients were allocated a Triathlon or a Kinemax TKA. Patients were assessed preoperatively, and one, three, eight, and 12 years postoperatively using the Oxford Knee Score (OKS). Reasons for patient lost to follow-up, mortality, and revision were recorded.Aims
Methods
The primary aim of this study is to quantify and compare outcomes following a dorsally displaced fracture of the distal radius in elderly patients (aged ≥ 65 years) who are managed conservatively versus with surgical fixation (open reduction and internal fixation). Secondary aims are to assess and compare upper limb-specific function, health-related quality of life, wrist pain, complications, grip strength, range of motion, radiological parameters, healthcare resource use, and cost-effectiveness between the groups. A prospectively registered (ISRCTN95922938) randomized parallel group trial will be conducted. Elderly patients meeting the inclusion criteria with a dorsally displaced distal radius facture will be randomized (1:1 ratio) to either conservative management (cast without further manipulation) or surgery. Patients will be assessed at six, 12, 26 weeks, and 52 weeks post intervention. The primary outcome measure and endpoint will be the Patient-Rated Wrist Evaluation (PRWE) at 52 weeks. In addition, the abbreviated version of the Disabilities of Arm, Shoulder and Hand questionnaire (QuickDASH), EuroQol five-dimension questionnaire, pain score (visual analogue scale 1 to 10), complications, grip strength (dynamometer), range of motion (goniometer), and radiological assessments will be undertaken. A cost-utility analysis will be performed to assess the cost-effectiveness of surgery. We aim to recruit 89 subjects per arm (total sample size 178).Aims
Methods
Despite the vast quantities of published artificial intelligence (AI) algorithms that target trauma and orthopaedic applications, very few progress to inform clinical practice. One key reason for this is the lack of a clear pathway from development to deployment. In order to assist with this process, we have developed the Clinical Practice Integration of Artificial Intelligence (CPI-AI) framework – a five-stage approach to the clinical practice adoption of AI in the setting of trauma and orthopaedics, based on the IDEAL principles ( Cite this article:
Vitamin E-doped cross-linked polyethylene (VEPE) has encouraged the use of larger heads in thinner liners in total hip arthroplasty (THA). However, there are concerns about wear and mechanical failure of the thin liner, especially when metal heads are used. The aim of this randomized controlled trial was to investigate if the use of a large metal head in a thin VEPE liner would increase polyethylene wear compared with a standard 32-mm metal head and to compare periacetabular radiolucencies and patient-reported outcomes in THA. 96 candidates for uncemented THA were randomly allocated to either the largest possible metal head (36–44 mm) that could be fitted in the thinnest available VEPE liner (intervention group) or a standard 32-mm metal head (control group). The primary outcome was proximal head penetration (PHP) measured with model-based radiostereometric analysis (RSA). Secondary outcomes were periacetabular radiolucencies and patient-reported outcomes. The mid-term results of the trial at 5 years are presented. Median total PHP (interquartile range) was -0.04 mm (−0.12 to 0.02) in the intervention group and -0.03 mm (=0.14 to 0.05) in the control group (p=0.691). The rates of periacetabular radiolucencies were 1/44 and 4/42 (p=0.197), respectively. Patient-reported hip function and health-related quality of life did not differ between the groups, but participants in the intervention group reported a higher level of activity (median UCLA rank 7 vs 6, p=0.020). There were 5 revisions caused by dislocations (2), periprosthetic fracture (1), stem subsidence (1), or iliopsoas impingement (1). Large metal heads in thin VEPE liners did not increase liner wear and were not associated with liner failure 5 years after THA.
The purpose of this randomized controlled trial was to evaluate serum metal levels in patients undergoing total hip arthroplasty (THA) with a conventional compared to a modular dual-mobility bearing. Patients undergoing primary THA for osteoarthritis were randomized to receive either a modular dual-mobility or conventional polyethylene bearing. All patients received the same titanium acetabular and femoral component and a ceramic femoral head. Serum metal levels were drawn pre-operatively then annually for a minimum of two years postoperatively. An Forty-six patients were randomized to a modular dual-mobility (n=25) or conventional bearing (n=21) with 40 at a minimum follow-up of two years. No differences in serum cobalt (mean 0.14 ppb [range, 0.075–0.29] vs. 0.20 ppb [range, 0.075–0.57], p=0.39) or chromium levels (mean 0.14 ppb [range, 0.05–0.50] vs. 0.12 ppb [range, 0.05–0.35], p=0.65) were identified between the modular dual-mobility and conventional cohorts, respectively. There was no statistically significant difference in serum Co or Cr at two years postoperatively in subjects implanted with a ceramic head and this particular dual mobility bearing in comparison to a ceramic head and a conventional acetabular component. While modest expected elevations in serum Co and Cr were observed in the dual mobility group, in no case did the Co level exceed the laboratory reference range nor the threshold of one part per billion that has been associated with adverse local tissue reactions to mechanically-assisted crevice corrosion.
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 randomised to receive either the DSA or PA for THA, surgery was undertaken using identical implant designs in both groups, and all patients received a standardized postoperative rehabilitation programme. Predefined study outcomes were recorded by blinded observers at regular intervals for two-years after THA. Radiosteriometric analysis (RSA) was used to assess implant migration. There were no statistical differences between the DSA and PA in postoperative pain scores (p=0.312), opiate analgesia consumption (p=0.067), and time to hospital discharge (p=0.416). At two years follow-up, both groups had comparable Oxford hip scores (p=0.476); Harris hip scores (p=0.293); Hip disability and osteoarthritis outcome scores (p=0.543); University of California at Los Angeles scores (p=0.609); Western Ontario and McMaster Universities Arthritis Index (p=0.833); and European Quality of Life questionnaire with 5 dimensions scores (p=0.418). Radiographic analysis revealed no difference between the two treatment groups for overall accuracy of acetabular cup positioning (p=0.687) and femoral stem alignment (p=0.564). RSA revealed no difference in femoral component migration (p=0.145) between the groups at two years follow-up. There were no differences between patients undergoing the DSA versus PA for THA with respect to postoperative pain scores, functional rehabilitation, patient-reported outcome measurements, accuracy of implant positioning, and implant migration at two years follow-up. Both treatment groups had excellent outcomes that remained comparable at all follow-up intervals.
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. A randomised clinical trial was conducted with 46 patients (50 feet) diagnosed with Morton's neuroma. After randomisation, the control group (CG) received three injections (one per week) of triamcinolone (Triancil®) guided by ultrasound, while the study group (SG) received three applications of hyaluronic acid (Osteonil Plus®). Patients were followed up for six months after the intervention. The primary outcome measure used was the Visual Pain Analog Scale (VAS). Secondary endpoints included patient-reported outcome measures using the American Orthopaedic Foot & Ankle Society (AOFAS) score and complications.Background
Methods
Studies have compared open reduction internal fixation (ORIF) with fibular nail fixation (FNF) and shown reduced wound complications with minimal difference to PROMS in the short term. Our aim is to compare long-term outcomes for unstable ankle fractures at 10 year follow up. Patients from a previously conducted RCT were contacted at a minimum of 10 years post intervention at a single study centre. Case notes were reviewed, and patient reported outcome measures acquired at 10 years.Background
Methods
Ankle fractures are extremely common but unfortunately, over 20% fail to obtain good to excellent recovery. For those requiring surgical fixation, usual-care post-surgery has included six-weeks cast immobilisation and non-weightbearing. Disuse atrophy and joint stiffness are detrimental sequelae of this management. While rehabilitation, starting at two-weeks post-surgery is viewed as safe, the literature contains methodological flaws and a lack of focus on early exercise, perpetuating the controversy over the effectiveness of early exercise interventions. Our objectives were to determine if following operative fixation for Weber B fracture, the physiotherapy intervention, early motion and directed exercise (EMADE), applied in the clinical setting, were superior to Usual-care at 12-weeks (primary outcome) and 24-weeks.Background
Objectives
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. 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.Objective
Methods
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 randomised controlled study across seven NHS England sites. 222 participants aged 18 to 60 years with FAI syndrome confirmed clinically and radiologically were randomised (1:1) to receive arthroscopic hip surgery (n = 112) or physiotherapy and activity modification (n = 110). We previously reported on the hip outcome score at eight months. The primary outcome measure of this study was minimum Joint Space Width (mJSW) on Anteroposterior Radiograph at 38 months post randomisation. Secondary outcome measures included the Hip Outcome Score and Scoring Hip Osteoarthritis with MRI (SHOMRI) score. Minimum Joint Space Width data were available for 101 participants (45%) at 38 months post randomisation. Hip outcome score and MRI data were available for 77% and 62% of participants respectively. mJSW was higher in the arthroscopy group (mean (SD) 3.34mm (1.01)) compared to the physiotherapy group (2.99mm (1.33)) at 38 months, p=0.017, however this did not exceed the minimally clinically important difference of 0.48mm. SHOMRI score was significantly lower in the arthroscopy group (mean (SD) 9.22 (11.43)) compared to the physiotherapy group (22.76 (15.26)), p-value <0.001. Hip outcome score was higher in the arthroscopy group (mean (SD) 84.2 (17.4)) compared with the physiotherapy group (74.2 (21.9)), p-value < 0.001). Patients with FAI syndrome treated surgically may experience slowing of osteoarthritisprogression and superior pain and function compared with patients treated non- operatively.
Proximal hamstring tendon avulsion from the ischial tuberosity is a significant injury, with surgical repair shown to have superior functional outcomes compared to non-surgical treatment. However, limited data exists regarding the optimal rehabilitation regime following surgical repair. The aim of this study was to investigate patient outcomes following repair of proximal hamstring tendon avulsions between a conservative (CR) versus an accelerated rehabilitation (AR) regimen. This prospective randomized controlled trial (RCT) randomised 50 patients undergoing proximal hamstring tendon repair to either a braced, partial weight-bearing rehabilitation regime (CR=25) or an accelerated, unbraced regime, that permitted full weight-bearing as tolerated (AR=25). Patients were evaluated pre-operatively and at 3 and 6 months post-surgery, via patient-reported outcome measures (PROMs) including the Lower Extremity Functional Scale (LEFS), Perth Hamstring Assessment Tool (PHAT) and 12-item Short Form Health Survey (SF-12). Primary analysis was per protocol and based on linear mixed models. Both groups were matched at baseline with respect to patient characteristics. All PROMs improved (p>0.05) and, while the AR group reported a significantly better Physical Component Score for the SF-12 at 3 months (p=0.022), there were no other group differences. Peak isometric hamstrings strength and peak isokinetic quadriceps and hamstrings torque symmetry were all comparable between groups (p>0.05). Three re-injuries have been observed (CR=2, AR=1). After proximal hamstring repair surgery, post-operative outcomes following an accelerated rehabilitation regimen demonstrate comparable outcomes to a traditionally conservative rehabilitation pathway, albeit demonstrating better early physical health-related quality of life scores, without an increased incidence of early re-injury.
Total hip and knee arthroplasty (THA, TKA) are largely successful procedures; however, both have variable outcomes, resulting in some patients being dissatisfied with the outcome. Surgeons are turning to technologies such as robotic-assisted surgery in an attempt to improve outcomes. Robust studies are needed to find out if these innovations are really benefitting patients. The Robotic Arthroplasty Clinical and Cost Effectiveness Randomised Controlled Trials (RACER) trials are multicentre, patient-blinded randomized controlled trials. The patients have primary osteoarthritis of the hip or knee. The operation is Mako-assisted THA or TKA and the control groups have operations using conventional instruments. The primary clinical outcome is the Forgotten Joint Score at 12 months, and there is a built-in analysis of cost-effectiveness. Secondary outcomes include early pain, the alignment of the components, and medium- to long-term outcomes. This annotation outlines the need to assess these technologies and discusses the design and challenges when conducting such trials, including surgical workflows, isolating the effect of the operation, blinding, and assessing the learning curve. Finally, the future of robotic surgery is discussed, including the need to contemporaneously introduce and evaluate such technologies. Cite this article:
Digital injuries are among the most common presentations to the emergency department. In order to sufficiently examine and manage these injuries, adequate, prompt, and predictable anaesthesia is essential. In this trial, we aim to primarily compare the degree of pain and anaesthesia onset time between the two-injection dorsal block technique (TD) and the single-injection volar subcutaneous block technique (SV). Further, we describe the temporal and anatomical effects of both techniques for an accurate delineation of the anesthetized regions. A single-centre prospective randomized controlled trial involving patients presenting with isolated wounds to the fingers requiring primary repair under local anaesthesia. Patients were randomized to either the SV or TD blocks. The primary outcome was procedure-related pain (Numerical Rating Scale). Further, we assessed the extent of anaesthesia along with the anaesthesia onset time.Background
Methods
Pseudoarthrosis after spinal fusion is an important complication leading to revision spine surgeries. Iliac Crest Bone Graft is considered the gold standard, but with limited availability and associated co-morbidities, spine surgeons often utilize alternative bone grafts. Determine the non-inferiority of a novel submicron-sized needle-shaped surface biphasic calcium phosphate (BCP<µm) as compared to autograft in instrumented posterolateral spinal fusion. Adult patients indicated for instrumented posterolateral spinal fusion of one to six levels from T10-S2 were enrolled at five participating centers. After instrumentation and preparation of the bone bed, the randomized allocation side of the graft type was disclosed. One side was grafted with 10cc of autograft per level containing a minimum of 50% iliac crest bone. The other side was grafted with 10cc of BCP<µm granules standalone (without autograft or bone marrow aspirate). In total, 71 levels were treated. Prospective follow-up included adverse events, Oswestry Disability Index (ODI), and a fine-cut Computerized Tomography (CT) at one year. Fusion was systematically scored as fused or not fused per level per side by two spine surgeons blinded for the procedure. The first fifty patients enrolled are included in this analysis (mean age: 57 years; 60% female and 40% male). The diagnoses included deformity (56%), structural instability (28%), and instability from decompression (20%). The fusion rate determined by CT for BCP<μm was 76.1%, which compared favorably to the autograft fusion rate of 43.7%. Statistical analysis through binomial modeling showed that the odds of fusion of BCP<μm was 2.54 times higher than that of autograft. 14% of patients experienced a procedure or possible device-related severe adverse event and there were four reoperations. Oswestry Disability Index (ODI) score decreased from a mean of 46.0 (±15.0) to a mean of 31.7 (±16.9), and 52.4% of patients improved with at least 15-point decrease. This data, aiming to determine non-inferiority of standalone BCP<μm as compared to autograft for posterior spinal fusions, is promising. Ongoing studies to increase the power of the statistics with more patients are forthcoming.