A novel enhanced cement fixation (EF) tibial implant with deeper cement pockets and a more roughened bonding surface was released to market for an existing total knee arthroplasty (TKA) system.This randomized controlled trial assessed fixation of the both the EF (ATTUNE S+) and standard (Std; ATTUNE S) using radiostereometric analysis. Overall, 50 subjects were randomized (21 EF-TKA and 23 Std-TKA in the final analysis), and had follow-up visits at six weeks, and six, 12, and 24 months to assess migration of the tibial component. Low viscosity bone cement with tobramycin was used in a standardized fashion for all subjects. Patient-reported outcome measure data was captured at preoperative and all postoperative visits.Aims
Methods
The aim of this trial was to assess the cost-effectiveness of a soft bandage and immediate discharge, compared with rigid immobilization, in children aged four to 15 years with a torus fracture of the distal radius. A within-trial economic evaluation was conducted from the UK NHS and personal social services (PSS) perspective, as well as a broader societal point of view. Health resources and quality of life (the youth version of the EuroQol five-dimension questionnaire (EQ-5D-Y)) data were collected, as part of the Forearm Recovery in Children Evaluation (FORCE) multicentre randomized controlled trial over a six-week period, using trial case report forms and patient-completed questionnaires. Costs and health gains (quality-adjusted life years (QALYs)) were estimated for the two trial treatment groups. Regression was used to estimate the probability of the new treatment being cost-effective at a range of ‘willingness-to-pay’ thresholds, which reflect a range of costs per QALY at which governments are typically prepared to reimburse for treatment.Aims
Methods
In this randomised controlled trial, we evaluated
the role of elastic compression using ankle injury stockings (AIS)
in the management of fractures of the ankle. A total of 90 patients
with a mean age of 47 years (16 to 79) were treated within 72 hours
of presentation with a fracture of the ankle, 31 of whom were treated
operatively and 59 conservatively, were randomised to be treated
either with compression by AIS plus an Aircast boot or Tubigrip
plus an Aircast boot. Male to female ratio was 36:54. The primary
outcome measure was the functional Olerud–Molander ankle score (OMAS).
The secondary outcome measures were; the American Orthopaedic Foot
and Ankle Society score (AOFAS); the Short Form (SF)-12v2 Quality
of Life score; and the frequency of deep vein thrombosis (DVT). Compression using AIS reduced swelling of the ankle at all time
points and improved the mean OMAS score at six months to 98 (95%
confidence interval (CI) 96 to 99) compared with a mean of 67 (95%
CI 62 to 73) for the Tubigrip group (p <
0.001). The mean AOFAS
and SF-12v2 scores at six months were also significantly improved
by compression. Of 86 patients with duplex imaging at four weeks,
five (12%) of 43 in the AIS group and ten (23%) of 43 in the Tubigrip
group developed a DVT (p = 0.26). Compression improved functional outcome and quality of life following
fracture of the ankle. DVTs were frequent, but a larger study would
be needed to confirm that compression with AISs reduces the incidence
of DVT. Cite this article:
We undertook a randomised clinical trial to compare
treatment times and failure rates between above- and below-knee
Ponseti casting groups. Eligible children with idiopathic clubfoot,
treated using the Ponseti method, were randomised to either below-
or above-knee plaster of Paris casting. Outcome measures were total
treatment time and the occurrence of failure, defined as two slippages
or a treatment time above eight weeks. A total of 26 children (33 feet) were entered into the trial.
The above-knee group comprised 17 feet in 13 children (ten boys
and three girls, median age 13 days (1 to 40)) and the below-knee
group comprised 16 feet in 13 children (ten boys and three girls,
median age 13 days (5 to 20)). Because of six failures (37.5%) in
the below-knee group, the trial was stopped early for ethical reasons.
The rate of failure was significantly higher in the below-knee group
(p = 0.039). The median treatment times of six weeks in the below-knee
and four weeks in the above-knee group differed significantly (p
= 0.01). This study demonstrates that the use of a below-knee plaster
of Paris cast in conjunction with the Ponseti technique leads to
unacceptably high failure rates and significantly longer treatment
times. Therefore, this technique is not recommended. Cite this article:
A total of 159 patients (84 women and 75 men,
mean age of 53 (20 to 87)) with subacromial impingement were randomised
to treatment with subacromial injections using lidocaine with one
of hyaluronic acid (51 patients), corticosteroid (53 patients) or
placebo (55 patients). Patients were followed up for 26 weeks. The
primary outcome was pain on a visual analogue score (VAS), and secondary
outcomes included the Constant Murley score, shoulder pain score,
functional mobility score, shoulder disability questionnaire and
pain-specific disability score. The different outcome measures showed
similar results. After three, six and 12 weeks corticosteroid injections
were superior to hyaluronic acid injections and only at six weeks
significantly better than placebo injections. The mean short-term
reduction in pain on the VAS score at 12 weeks was 7% ( We were not able to show a convincing benefit from hyaluronic
acid injections compared with corticosteroid or placebo injections.
Corticosteroid injections produced a significant reduction in pain
in the short term (three to 12 weeks), but in the long term the
placebo injection produced the best results.
This study compared the outcome of total knee
replacement (TKR) in adult patients with fixed- and mobile-bearing prostheses
during the first post-operative year and at five years’ follow-up,
using gait parameters as a new objective measure. This double-blind
randomised controlled clinical trial included 55 patients with mobile-bearing (n
= 26) and fixed-bearing (n = 29) prostheses of the same design,
evaluated pre-operatively and post-operatively at six weeks, three
months, six months, one year and five years. Each participant undertook
two walking trials of 30 m and completed the EuroQol questionnaire,
Western Ontario and McMaster Universities osteoarthritis index,
Knee Society score, and visual analogue scales for pain and stiffness.
Gait analysis was performed using five miniature angular rate sensors
mounted on the trunk (sacrum), each thigh and calf. The study population
was divided into two groups according to age (≤ 70 years Improvements in most gait parameters at five years’ follow-up
were greater for fixed-bearing TKRs in older patients (>
70 years),
and greater for mobile-bearing TKRs in younger patients (≤ 70 years).
These findings should be confirmed by an extended age controlled
study, as the ideal choice of prosthesis might depend on the age
of the patient at the time of surgery.
Aims. Treatment of Weber B ankle fractures that are stable on weightbearing radiographs but unstable on concomitant stress tests (classified SER4a) is controversial. Recent studies indicate that these fractures should be treated nonoperatively, but no studies have compared alternative nonoperative options. This study aims to evaluate patient-reported outcomes and the safety of fracture treatment using functional orthosis versus cast immobilization. Methods. A total of 110 patients with Weber B/SER4a ankle fractures will be randomized (1:1 ratio) to receive six weeks of functional orthosis treatment or cast immobilization with a two-year follow-up. The primary outcome is patient-reported ankle function and symptoms measured by the Manchester-Oxford Foot and Ankle Questionnaire (MOxFQ); secondary outcomes include Olerud-Molander Ankle Score, radiological evaluation of ankle congruence in weightbearing and gravity stress tests, and rates of treatment-related adverse events. The Regional Committee for Medical and Health Research (approval number 277693) has granted ethical approval, and the study is funded by South-Eastern Norway Regional Health Authority (grant number 2023014). Discussion.
Aims. Intra-articular (IA) injection may be used when treating hip osteoarthritis (OA). Common injections include steroids, hyaluronic acid (HA), local anaesthetic, and platelet-rich plasma (PRP). Network meta-analysis allows for comparisons between two or more treatment groups and uses direct and indirect comparisons between interventions. This network meta-analysis aims to compare the efficacy of various IA injections used in the management of hip OA with a follow-up of up to six months. Methods. This systematic review and network meta-analysis used a Bayesian random-effects model to evaluate the direct and indirect comparisons among all treatment options. PubMed, Web of Science, Clinicaltrial.gov, EMBASE, MEDLINE, and the Cochrane Library were searched from inception to February 2023.
The application of robotics in the operating theatre for knee arthroplasty remains controversial. As with all new technology, the introduction of new systems might be associated with a learning curve. However, guidelines on how to assess the introduction of robotics in the operating theatre are lacking. This systematic review aims to evaluate the current evidence on the learning curve of robot-assisted knee arthroplasty. An extensive literature search of PubMed, Medline, Embase, Web of Science, and Cochrane Library was conducted.
Chronic osteomyelitis (COM) of the lower limb in adults can be surgically managed by either limb reconstruction or amputation. This scoping review aims to map the outcomes used in studies surgically managing COM in order to aid future development of a core outcome set. A total of 11 databases were searched. A subset of studies published between 1 October 2020 and 1 January 2011 from a larger review mapping research on limb reconstruction and limb amputation for the management of lower limb COM were eligible. All outcomes were extracted and recorded verbatim. Outcomes were grouped and categorized as per the revised Williamson and Clarke taxonomy.Aims
Methods
Perthes' disease (PD) is a relatively rare syndrome of idiopathic osteonecrosis of the proximal femoral epiphysis. Treatment for Perthes' disease is controversial due to the many options available, with no clear superiority of one treatment over another. Despite having few evidence-based approaches, many patients with Perthes' disease are managed surgically. Positive outcome reporting, defined as reporting a study variable producing statistically significant positive (beneficial) results, is a phenomenon that can be considered a proxy for the strength of science. This study aims to conduct a systematic literature review with the hypothesis that positive outcome reporting is frequent in studies on the treatment of Perthes' disease. We conducted a systematic review of all available abstracts associated with manuscripts in English or with English translation between January 2000 and December 2021, dealing with the treatment of Perthes' disease. Data collection included various study characteristics, surgical versus non-surgical management, treatment modality, mean follow-up time, analysis methods, and clinical recommendations.Aims
Methods
Musculoskeletal diseases are having a growing impact worldwide. It is therefore crucial to have an evidence base to most effectively and efficiently implement future health services across different healthcare systems. International trials are an opportunity to address these challenges and have many potential benefits. They are, however, complex to set up and deliver, which may impact on the efficient and timely delivery of a project. There are a number of models of how international trials are currently being delivered across a range of orthopaedic patient populations, which are discussed here. The examples given highlight that the key to overcoming these challenges is the development of trusted and equal partnerships with collaborators in each country. International trials have the potential to address a global burden of disease, and in turn optimize the benefit to patients in the collaborating countries and those with similar health services and care systems. Cite this article:
Osteoporosis is common in total hip arthroplasty (THA) patients. It plays a substantial factor in the surgery’s outcome, and previous studies have revealed that pharmacological treatment for osteoporosis influences implant survival rate. The purpose of this study was to examine the prevalence of and treatment rates for osteoporosis prior to THA, and to explore differences in osteoporosis-related biomarkers between patients treated and untreated for osteoporosis. This single-centre retrospective study included 398 hip joints of patients who underwent THA. Using medical records, we examined preoperative bone mineral density measures of the hip and lumbar spine using dual energy X-ray absorptiometry (DXA) scans and the medications used to treat osteoporosis at the time of admission. We also assessed the following osteoporosis-related biomarkers: tartrate-resistant acid phosphatase 5b (TRACP-5b); total procollagen type 1 amino-terminal propeptide (total P1NP); intact parathyroid hormone; and homocysteine.Aims
Methods
The December 2022 Hip & Pelvis Roundup360 looks at: Fix and replace: simultaneous fracture fixation and hip arthroplasty for acetabular fractures in older patients; Is the revision rate for femoral neck fracture lower for total hip arthroplasty than for hemiarthroplasty?; Femoral periprosthetic fractures: data from the COMPOSE cohort study; Dual-mobility cups and fracture of the femur; What’s the deal with outcomes for hip and knee arthroplasty outcomes internationally?; Osteochondral lesions of the femoral head: is costal cartilage the answer?
The principles of evidence-based medicine (EBM) are the foundation of modern medical practice. Surgeons are familiar with the commonly used statistical techniques to test hypotheses, summarize findings, and provide answers within a specified range of probability. Based on this knowledge, they are able to critically evaluate research before deciding whether or not to adopt the findings into practice. Recently, there has been an increased use of artificial intelligence (AI) to analyze information and derive findings in orthopaedic research. These techniques use a set of statistical tools that are increasingly complex and may be unfamiliar to the orthopaedic surgeon. It is unclear if this shift towards less familiar techniques is widely accepted in the orthopaedic community. This study aimed to provide an exploration of understanding and acceptance of AI use in research among orthopaedic surgeons. Semi-structured in-depth interviews were carried out on a sample of 12 orthopaedic surgeons. Inductive thematic analysis was used to identify key themes.Aims
Methods
Early large treatment effects can arise in small studies, which lessen as more data accumulate. This study aimed to retrospectively examine whether early treatment effects occurred for two multicentre orthopaedic randomized controlled trials (RCTs) and explore biases related to this. Included RCTs were ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation), a two-arm study of surgery versus non-surgical treatment for proximal humerus fractures, and UK FROST (United Kingdom Frozen Shoulder Trial), a three-arm study of two surgical and one non-surgical treatment for frozen shoulder. To determine whether early treatment effects were present, the primary outcome of Oxford Shoulder Score (OSS) was compared on forest plots for: the chief investigator’s (CI) site to the remaining sites, the first five sites opened to the other sites, and patients grouped in quintiles by randomization date. Potential for bias was assessed by comparing mean age and proportion of patients with indicators of poor outcome between included and excluded/non-consenting participants.Aims
Methods
Open lower limb fracture is a life-changing injury affecting 11.5 per 100,000 adults each year, and causes significant morbidity and resource demand on trauma infrastructures. This study aims to identify what, and how, outcomes have been reported for people following open lower limb fracture over ten years. Systematic literature searches identified all clinical studies reporting outcomes for adults following open lower limb fracture between January 2009 and July 2019. All outcomes and outcome measurement instruments were extracted verbatim. An iterative process was used to group outcome terms under standardized outcome headings categorized using an outcome taxonomy.Aims
Methods
Patients with A1 and A2 trochanteric hip fractures represent a substantial proportion of trauma caseload, and national guidelines recommend that sliding hip screws (SHS) should be used for these injuries. Despite this, intramedullary nails (IMNs) are routinely implanted in many hospitals, at extra cost and with unproven patient outcome benefit. We have used data from the National Hip Fracture Database (NHFD) to examine the use of SHS and IMN for A1 and A2 hip fractures at a national level, and to define the cost implications of management decisions that run counter to national guidelines. We used the NHFD to identify all operations for fixation of trochanteric fractures in England and Wales between 1 January 2021 and 31 December 2021. A uniform price band from each of three hip fracture implant manufacturers was used to set cost implications alongside variation in implant use.Aims
Methods
Initial treatment of traumatic spinal cord injury remains as controversial in 2023 as it was in the early 19th century, when Sir Astley Cooper and Sir Charles Bell debated the merits or otherwise of surgery to relieve cord compression. There has been a lack of high-class evidence for early surgery, despite which expeditious intervention has become the surgical norm. This evidence deficit has been progressively addressed in the last decade and more modern statistical methods have been used to clarify some of the issues, which is demonstrated by the results of the SCI-POEM trial. However, there has never been a properly conducted trial of surgery versus active conservative care. As a result, it is still not known whether early surgery or active physiological management of the unstable injured spinal cord offers the better chance for recovery. Surgeons who care for patients with traumatic spinal cord injuries in the acute setting should be aware of the arguments on all sides of the debate, a summary of which this annotation presents. Cite this article:
The aim of this study was to explore clinicians’ experience of a paediatric randomized controlled trial (RCT) comparing surgical reduction with non-surgical casting for displaced distal radius fractures. Overall, 22 staff from 15 hospitals who participated in the RCT took part in an interview. Interviews were informed by phenomenology and analyzed using thematic analysis.Aims
Methods