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
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. 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.Introduction
Methods
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
Disability and slow return to sport and work after tendon rupture are major challenges. Platelet Rich Plasma (PRP) is an autologous supraphysiological concentration of platelets from whole blood that has demonstrated positive cellular and physiological effects on healing in laboratory conditions but evidence from adequately powered robust clinical trials is lacking. We aimed to determine the clinical efficacy of PRP for treatment of acute Achilles tendon rupture. In a placebo-controlled, participant- and assessor-blinded, trial at 19 NHS hospitals we randomly assigned 230 adults starting acute Achilles rupture non-surgical management to PRP injection or dry-needle insertion (placebo) to the rupture gap under local anaesthetic. Patients with confounding or contraindicated concurrent medical conditions were excluded. The primary outcome was muscle-tendon function, assessed by the limb symmetry index (LSI, uninjured limb/injured limb × 100, higher scores better) of the work (Joules) performed during the heel-rise endurance test at 24 weeks. Secondary outcomes were: Achilles Tendon Rupture Score (ATRS, 0–100, higher scores better), quality of life (SF-12), pain, and goal attainment. Trial registration: ISRCTN54992179Background
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.
The aims of this study were to identify and evaluate the current literature examining the prognostic factors which are associated with failure of total elbow arthroplasty (TEA). Electronic literature searches were conducted using MEDLINE, Embase, PubMed, and Cochrane. All studies reporting prognostic estimates for factors associated with the revision of a primary TEA were included. The risk of bias was assessed using the Quality In Prognosis Studies (QUIPS) tool, and the quality of evidence was assessed using the modified Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) framework. Due to low quality of the evidence and the heterogeneous nature of the studies, a narrative synthesis was used.Aims
Methods
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.
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
In 10% of the presumed aseptic hip or knee revisions, a low-grade infection is unexpectedly diagnosed based on the tissue samples taken during revision. Extended antimicrobial prophylaxis can possibly reduce the failure rate in cases of unexpected PJI, because the prophylaxis can be considered as early empiric treatment. In this randomized controlled study we analysed whether extended antimicrobial prophylaxis compared to a single dose is beneficial to improve the outcome of treatment in unexpected PJI in revision arthroplasty. This study was nested in a randomized clinical trial comparing single-dose cefazolin with prolonged prophylaxis (15 doses of cefazolin over 5 days) for revision arthroplasty of the hip or knee. For this analysis, patients were included if an unsuspected PJI (defined as ≥2 positive intraoperative tissue samples with the same microorganism) was diagnosed. PJI treatment consisted of 12 weeks of a rifampicin-based regimen in Staphylococcal PJI, without removal of the prosthesis. We examined Infection characteristics and success of treatment after one year, defined as the absence of signs or treatment for PJI during follow-up.Aim
Method
To perform an incremental cost-utility analysis and assess the impact of differential costs and case volume on the cost-effectiveness of robotic arm-assisted unicompartmental knee arthroplasty (rUKA) compared to manual (mUKA). This was a five-year follow-up study of patients who were randomized to rUKA (n = 64) or mUKA (n = 65). Patients completed the EuroQol five-dimension questionnaire (EQ-5D) preoperatively, and at three months and one, two, and five years postoperatively, which was used to calculate quality-adjusted life years (QALYs) gained. Costs for the primary and additional surgery and healthcare costs were calculated.Aims
Methods
Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of ‘full-time bracing’ versus ‘night-time bracing’ in adolescent idiopathic scoliosis (AIS). UK paediatric spine clinics will recruit 780 participants aged ten to 15 years-old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20° to 40° with apex at or below T7. Patients are randomly allocated 1:1, to either full-time or night-time bracing. A qualitative sub-study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed study design and will assist with aspects of trial delivery and dissemination.Aims
Methods
Aims. Hip fractures are a major cause of morbidity and mortality, and malnutrition is a crucial determinant of these outcomes. This meta-analysis aims to determine whether oral nutritional supplementation (ONS) improves postoperative outcomes in older patients with a hip fracture. Methods. A systematic literature search was conducted in August 2022. ONS was defined as high protein-based diet strategies containing (or not containing) carbohydrates, fat, vitamins, and minerals.
The aim of this study was to report the three-year follow-up for a series of 400 patients with a displaced intracapsular fracture of the hip, who were randomized to be treated with either a cemented polished tapered hemiarthroplasty or an uncemented hydroxyapatite-coated hemiarthroplasty. The mean age of the patients was 85 years (58 to 102) and 273 (68%) were female. Follow-up was undertaken by a nurse who was blinded to the hemiarthroplasty that was used, at intervals for up to three years from surgery. The short-term follow-up of these patients at a mean of one year has previously been reported.Aims
Methods
