Aims. To assess the feasibility of a randomized controlled trial (RCT) that compares three treatments for acetabular fractures in older patients: surgical fixation, surgical fixation and hip arthroplasty (fix-and-replace), and non-surgical treatment. Methods. Patients were recruited from seven UK NHS centres and randomized to a three-arm pilot trial if aged older than 60 years and had a displaced acetabular fracture.
This aim of this study was to assess the feasibility of designing and introducing generic 3D-printed instrumentation for routine use in total knee arthroplasty. Instruments were designed to take advantage of 3D-printing technology, particularly ensuring that all parts were pre-assembled, to theoretically reduce the time and skill required during surgery. Concerning functionality, ranges of resection angle and distance were restricted within a safe zone, while accommodating either mechanical or anatomical alignment goals. To identify the most suitable biocompatible materials, typical instrument shapes and mating parts, such as dovetails and screws, were designed and produced.Aims
Materials and Methods
The number of surgical procedures performed each year to treat
femoroacetabular impingement (FAI) continues to rise. Although there
is evidence that surgery can improve symptoms in the short-term,
there is no evidence that it slows the development of osteoarthritis
(OA). We performed a feasibility study to determine whether patient
and surgeon opinion was permissive for a Randomised Controlled Trial
(RCT) comparing operative with non-operative treatment for FAI. Surgeon opinion was obtained using validated questionnaires at
a Specialist Hip Meeting (n = 61, 30 of whom stated that they routinely
performed FAI surgery) and patient opinion was obtained from clinical
patients with a new diagnosis of FAI (n = 31).Objectives
Methods
Over 15 years (1967 to 1982) 140 uncomplicated femoral shaft fractures in children under four years of age were successfully treated using Bryant's traction. Forty of these children were treated after the introduction of the domiciliary management policy in 1976; 13 children were managed at hospital and 27 were managed at home. No significant complications occurred. The advantages to the family, and the safety and economy of domiciliary management lead us to recommend its adoption in favourable cases. Treatment at home relies on an efficient and experienced home nursing service. Possible complications of the injury and treatment with recommendations to prevent them are discussed.
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. Results. We will conduct a multicentre RCT comparing CSI and HD in combination with CSI alone. Patients aged 18 years and over with a clinical diagnosis of frozen shoulder will be randomized and blinded to receive either CSI and HD in combination, or CSI alone.
Aims. To identify a core outcome set of postoperative radiographic measurements to assess technical skill in ankle fracture open reduction internal fixation (ORIF), and to validate these against Van der Vleuten’s criteria for effective assessment. Methods. An e-Delphi exercise was undertaken at a major trauma centre (n = 39) to identify relevant parameters.
A core outcome set for adult, open lower limb fracture has been established consisting of ‘Walking, gait and mobility’, ‘Being able to return to life roles’, ‘Pain or discomfort’, and ‘Quality of life’. This study aims to identify which outcome measurement instruments (OMIs) should be recommended to measure each core outcome. A systematic review and quality assessment were conducted to identify existing instruments with evidence of good measurement properties in the open lower limb fracture population for each core outcome. Additionally, shortlisting criteria were developed to identify suitable instruments not validated in the target population. Candidate instruments were presented, discussed, and voted on at a consensus meeting of key stakeholders.Aims
Methods
Hand trauma, consisting of injuries to both the hand and the wrist, are a common injury seen worldwide. The global age-standardized incidence of hand trauma exceeds 179 per 100,000. Hand trauma may require surgical management and therefore result in significant costs to both healthcare systems and society. Surgical site infections (SSIs) are common following all surgical interventions, and within hand surgery the risk of SSI is at least 5%. SSI following hand trauma surgery results in significant costs to healthcare systems with estimations of over £450 per patient. The World Health Organization (WHO) have produced international guidelines to help prevent SSIs. However, it is unclear what variability exists in the adherence to these guidelines within hand trauma. The aim is to assess compliance to the WHO global guidelines in prevention of SSI in hand trauma. This will be an international, multicentre audit comparing antimicrobial practices in hand trauma to the standards outlined by WHO. Through the Reconstructive Surgery Trials Network (RSTN), hand surgeons across the globe will be invited to participate in the study. Consultant surgeons/associate specialists managing hand trauma and members of the multidisciplinary team will be identified at participating sites. Teams will be asked to collect data prospectively on a minimum of 20 consecutive patients. The audit will run for eight months. Data collected will include injury details, initial management, hand trauma team management, operation details, postoperative care, and antimicrobial techniques used throughout. Adherence to WHO global guidelines for SSI will be summarized using descriptive statistics across each criteria.Aims
Methods
The August 2023 Trauma Roundup360 looks at: A comparison of functional cast and volar-flexion ulnar deviation for dorsally displaced distal radius fractures; Give your stable ankle fractures some AIR!; Early stabilization of rib fractures – an effective thing to do?; Locked plating versus nailing for proximal tibia fractures: A multicentre randomized controlled trial; Time to flap coverage in open tibia fractures; Does tranexamic acid affect the incidence of heterotropic ossification around the elbow?; High BMI – good or bad in surgical fixation of hip fractures?
The primary aim of this study was to assess the feasibility of recruiting and retaining patients to a patient-blinded randomized controlled trial comparing corticosteroid injection (CSI) to autologous protein solution (APS) injection for the treatment of subacromial shoulder pain in a community care setting. The study focused on recruitment rates and retention of participants throughout, and collected data on the interventions’ safety and efficacy. Participants were recruited from two community musculoskeletal treatment centres in the UK. Patients were eligible if aged 18 years or older, and had a clinical diagnosis of subacromial impingement syndrome which the treating clinician thought was suitable for treatment with a subacromial injection. Consenting patients were randomly allocated 1:1 to a patient-blinded subacromial injection of CSI (standard care) or APS. The primary outcome measures of this study relate to rates of recruitment, retention, and compliance with intervention and follow-up to determine feasibility. Secondary outcome measures relate to the safety and efficacy of the interventions.Aims
Methods
In order to release the contracture band completely without damaging normal tissues (such as the sciatic nerve) in the surgical treatment of gluteal muscle contracture (GMC), we tried to display the relationship between normal tissue and contracture bands by magnetic resonance neurography (MRN) images, and to predesign a minimally invasive surgery based on the MRN images in advance. A total of 30 patients (60 hips) were included in this study. MRN scans of the pelvis were performed before surgery. The contracture band shape and external rotation angle (ERA) of the proximal femur were also analyzed. Then, the minimally invasive GMC releasing surgery was performed based on the images and measurements, and during the operation, incision lengths, surgery duration, intraoperative bleeding, and complications were recorded; the time of the first postoperative off-bed activity was also recorded. Furthermore, the patients’ clinical functions were evaluated by means of Hip Outcome Score (HOS) and Ye et al’s objective assessments, respectively.Aims
Methods
Hand trauma accounts for one in five of emergency department attendances, with a UK incidence of over five million injuries/year and 250,000 operations/year. Surgical site infection (SSI) in hand trauma surgery leads to further interventions, poor outcomes, and prolonged recovery, but has been poorly researched. Antimicrobial sutures have been recognized by both the World Health Organization and the National Institute for Clinical Excellence as potentially effective for reducing SSI. They have never been studied in hand trauma surgery: a completely different patient group and clinical pathway to previous randomized clinical trials (RCTs) of these sutures. Antimicrobial sutures are expensive, and further research in hand trauma is warranted before they become standard of care. The aim of this protocol is to conduct a feasibility study of antimicrobial sutures in patients undergoing hand trauma surgery to establish acceptability, compliance, and retention for a definitive trial. A two-arm, multicentre feasibility RCT of 116 adult participants with hand and wrist injuries, randomized to either antimicrobial sutures or standard sutures. Study participants and outcome assessors will be blinded to treatment allocation. Outcome measures will be recorded at baseline (preoperatively), 30 days, 90 days, and six months, and will include SSI, patient-reported outcome measures, and return to work.Aims
Methods
Patients undergoing limb reconstruction surgery often face a challenging and lengthy process to complete their treatment journey. The majority of existing outcome measures do not adequately capture the patient-reported outcomes relevant to this patient group in a single measure. Following a previous systematic review, the Stanmore Limb Reconstruction Score (SLRS) was designed with the intent to address this need for an effective instrument to measure patient-reported outcomes in limb reconstruction patients. We aim to assess the face validity of this score in a pilot study. The SLRS was designed following structured interviews with several groups including patients who have undergone limb reconstruction surgery, limb reconstruction surgeons, specialist nurses, and physiotherapists. This has subsequently undergone further adjustment for language and clarity. The score was then trialled on ten patients who had undergone limb reconstruction surgery, with subsequent structured questioning to understand the perceived suitability of the score.Aims
Methods
This study aims to assess the feasibility of conducting a pragmatic, multicentre randomized controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery. This will be a mixed-methods feasibility RCT, recruiting 60 patients following hip fracture surgery and their informal caregivers. Patients will be randomized to usual NHS care, versus usual NHS care plus a caregiver-patient dyad training programme (HIP HELPER). This programme will comprise of three, one-hour, one-to-one training sessions for the patient and caregiver, delivered by a nurse, physiotherapist, or occupational therapist. Training will be delivered in the hospital setting pre-patient discharge. It will include practical skills for rehabilitation such as: transfers and walking; recovery goal setting and expectations; pacing and stress management techniques; and introduction to the HIP HELPER Caregiver Workbook, which provides information on recovery, exercises, worksheets, and goal-setting plans to facilitate a ‘good’ recovery. After discharge, patients and caregivers will be supported in delivering rehabilitation through three telephone coaching sessions. Data, collected at baseline and four months post-randomization, will include: screening logs, intervention logs, fidelity checklists, quality assurance monitoring visit data, and clinical outcomes assessing quality of life, physical, emotional, adverse events, and resource use outcomes. The acceptability of the study intervention and RCT design will be explored through qualitative methods with 20 participants (patients and informal caregivers) and 12 health professionals.Aims
Methods
Patient-reported outcome measures (PROMs) are being used increasingly in total knee arthroplasty (TKA). We conducted a systematic review aimed at identifying psychometrically sound PROMs by appraising their measurement properties. Studies concerning the development and/or evaluation of the measurement properties of PROMs used in a TKA population were systematically retrieved via PubMed, Web of Science, Embase, and Scopus. Ratings for methodological quality and measurement properties were conducted according to updated COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Of the 155 articles on 34 instruments included, nine PROMs met the minimum requirements for psychometric validation and can be recommended to use as measures of TKA outcome: Oxford Knee Score (OKS); OKS–Activity and Participation Questionnaire (OKS-APQ); 12-item short form Knee Injury and Osteoarthritis Outcome (KOOS-12); KOOS Physical function Short form (KOOS-PS); Western Ontario and McMaster Universities Arthritis Index-Total Knee Replacement function short form (WOMAC-TKR); Lower Extremity Functional Scale (LEFS); Forgotten Joint Score (FJS); Patient’s Knee Implant Performance (PKIP); and University of California Los Angeles (UCLA) activity score. The pain and function subscales in WOMAC, as well as the pain, function, and quality of life subscales in KOOS, were validated psychometrically as standalone subscales instead of as whole instruments. However, none of the included PROMs have been validated for all measurement properties. Thus, further studies are still warranted to evaluate those PROMs. Use of the other 25 scales and subscales should be tempered until further studies validate their measurement properties. Cite this article:
To explore staff experiences of a multicentre pilot randomized controlled trial (RCT) comparing intramedullary nails and circular frame external fixation for segmental tibial fractures. A purposeful sample of 19 staff (nine surgeons) involved in the study participated in an interview. Interviews explored participants’ experience and views of the study and the treatments. The interviews drew on phenomenology, were face-to-face or by telephone, and were analyzed using thematic analysis.Aims
Methods
Open reduction in developmental dysplasia of the hip (DDH) is regularly performed despite screening programmes, due to failure of treatment or late presentation. A protocol for open reduction of DDH has been refined through collaboration between surgical, anaesthetic, and nursing teams to allow same day discharge. The objective of this study was to determine the safety and feasibility of performing open reduction of DDH as a day case. A prospectively collected departmental database was visited. All consecutive surgical cases of DDH between June 2015 and March 2020 were collected. Closed reductions, bilateral cases, cases requiring corrective osteotomy, and children with comorbidities were excluded. Data collected included demographics, safety outcome measures (blood loss, complications, readmission, reduction confirmation), and feasibility for discharge according to the Face Legs Activity Cry Consolidability (FLACC) pain scale. A satisfaction questionnaire was filled by the carers. Descriptive statistics were used for analysis.Aims
Methods
This study sought to compare the rate of deep surgical site infection (SSI), as measured by the Centers for Disease Control and Prevention (CDC) definition, after surgery for a fracture of the hip between patients treated with standard dressings and those treated with incisional negative pressure wound therapy (iNPWT). Secondary objectives included determining the rate of recruitment and willingness to participate in the trial. The study was a two-arm multicentre randomized controlled feasibility trial that was embedded in the World Hip Trauma Evaluation cohort study. Any patient aged > 65 years having surgery for hip fracture at five recruitment centres in the UK was considered to be eligible. They were randomly allocated to have either a standard dressing or iNPWT after closure of the wound. The primary outcome measure was deep SSI at 30 and 90 days, diagnosed according to the CDC criteria. Secondary outcomes were: rate of recruitment; further surgery within 120 days; health-related quality of life (HRQoL) using the EuroQol five-level five-dimension questionnaire (EQ-5D-5L); and related complications within 120 days as well as mobility and residential status at this time.Aims
Methods
Distal radial fractures are the most common fracture sustained by the adult population. Most can be treated using cast immobilization without the need for surgery. The aim of this study was to assess the feasibility of a definitive trial comparing the commonly used fibreglass cast immobilization with an alternative product called Woodcast. Woodcast is a biodegradable casting material with theoretical benefits in terms of patient comfort as well as benefits to the environment. This was a multicentre, two-arm, open-label, parallel-group randomized controlled feasibility trial. Patients with a fracture of the distal radius aged 16 years and over were recruited from four centres in the UK and randomized (1:1) to receive a Woodcast or fibreglass cast. Data were collected on participant recruitment and retention, clinical efficacy, safety, and patient acceptability.Aims
Methods
To analyze outcomes reported in studies of Ponseti correction of idiopathic clubfoot. A systematic review of the literature was performed to identify a list of outcomes and outcome tools reported in the literature. A total of 865 studies were screened following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and 124 trials were included in the analysis. Data extraction was completed by two researchers for each trial. Each outcome tool was assigned to one of the five core areas defined by the Outcome Measures Recommended for use in Randomized Clinical Trials (OMERACT). Bias assessment was not deemed necessary for the purpose of this paper.Aims
Methods
To develop a core outcome set of measurements from postoperative radiographs that can be used to assess technical skill in performing dynamic hip screw (DHS) and hemiarthroplasty, and to validate these against Van der Vleuten’s criteria for effective assessment. A Delphi exercise was undertaken at a regional major trauma centre to identify candidate measurement items. The feasibility of taking these measurements was tested by two of the authors (HKJ, GTRP). Validity and reliability were examined using the radiographs of operations performed by orthopaedic resident participants (n = 28) of a multicentre randomized controlled educational trial (ISRCTN20431944). Trainees were divided into novice and intermediate groups, defined as having performed < ten or ≥ ten cases each for DHS and hemiarthroplasty at baseline. The procedure-based assessment (PBA) global rating score was assumed as the gold standard assessment for the purposes of concurrent validity. Intra- and inter-rater reliability testing were performed on a random subset of 25 cases.Aims
Methods
The aim of this study was to assess the feasibility of conducting a full-scale, appropriately powered, randomized controlled trial (RCT) comparing internal fracture fixation and distal femoral replacement (DFR) for distal femoral fractures in older patients. Seven centres recruited patients into the study. Patients were eligible if they were greater than 65 years of age with a distal femoral fracture, and if the surgeon felt that they were suitable for either form of treatment. Outcome measures included the patients’ willingness to participate, clinicians’ willingness to recruit, rates of loss to follow-up, the ability to capture data, estimates of standard deviation to inform the sample size calculation, and the main determinants of cost. The primary clinical outcome measure was the EuroQol five-dimensional index (EQ-5D) at six months following injury.Aims
Patients and Methods
Outcome measures quantifying aspects of health in a precise,
efficient, and user-friendly manner are in demand. Computer adaptive
tests (CATs) may overcome the limitations of established fixed scales
and be more adept at measuring outcomes in trauma. The primary objective
of this review was to gain a comprehensive understanding of the
psychometric properties of CATs compared with fixed-length scales
in the assessment of outcome in patients who have suffered trauma
of the upper limb. Study designs, outcome measures and methodological
quality are defined, along with trends in investigation. A search of multiple electronic databases was undertaken on 1
January 2017 with terms related to “CATs”, “orthopaedics”, “trauma”,
and “anatomical regions”. Studies involving adults suffering trauma
to the upper limb, and undergoing any intervention, were eligible.
Those involving the measurement of outcome with any CATs were included.
Identification, screening, and eligibility were undertaken, followed
by the extraction of data and quality assessment using the Consensus-Based
Standards for the Selection of Health Measurement Instruments (COSMIN) criteria.
The review is reported according to the Preferred Reporting Items
for Systematic Reviews and Meta-Analyses (PRISMA) criteria and reg istered (PROSPERO: CRD42016053886).Aims
Materials and Methods
Clinical studies of patients with bone sarcomas have been challenged
by insufficient numbers at individual centres to draw valid conclusions.
Our objective was to assess the feasibility of conducting a definitive
multi-centre randomised controlled trial (RCT) to determine whether
a five-day regimen of post-operative antibiotics, in comparison
to a
24-hour regimen, decreases surgical site infections in patients
undergoing endoprosthetic reconstruction for lower extremity primary
bone tumours. We performed a pilot international multi-centre RCT. We used
central randomisation to conceal treatment allocation and sham antibiotics
to blind participants, surgeons, and data collectors. We determined
feasibility by measuring patient enrolment, completeness of follow-up,
and protocol deviations for the antibiotic regimens. Objective
Methods
We present the validation of a translation into
Danish of the Oxford ankle foot questionnaire (OxAFQ). We followed the
Isis Pros guidelines for translation and pilot-tested the questionnaire
on ten children and their parents. Following modifications we tested
the validity of the final questionnaire on 82 children (36 boys
and 45 girls) with a mean age of 11.7 years (5.5 to 16.0) and their
parents. We tested the reliability (repeatability (test–retest),
child–parent agreement, internal consistency), feasibility (response
rate, time to completion, floor and ceiling effects) and construct
validity. The generic child health questionnaire was used for comparison.
We found good internal consistency for the physical and the school
and play domains, but lower internal consistency for the emotional domain.
Overall, good repeatability was found within children and parents
as well as agreement between children and parents. The OxAFQ was
fast and easy to complete, but we observed a tendency towards ceiling
effects in the school and play and emotional domains. To our knowledge
this is the first independent validation of the OxAFQ in any language.
We found it valid and feasible for use in the clinic to assess the
impact on children’s lives of foot and/or ankle disorders. It is
a valuable research tool. Cite this article:
The surgical community is plagued with a reputation
for both failing to engage and to deliver on clinical research.
This is in part due to the absence of a strong research culture, however
it is also due to a multitude of barriers encountered in clinical
research; particularly those involving surgical interventions. ‘Trauma’
amplifies these barriers, owing to the unplanned nature of care,
unpredictable work patterns, the emergent nature of treatment and
complexities in the consent process. This review discusses the barriers
to clinical research in surgery, with a particular emphasis on trauma.
It considers how barriers may be overcome, with the aim to facilitate
future successful clinical research. Cite this article:
The risk of venous thromboembolism in patients following arthroplasty may be reduced by continuing chemical thromboprophylaxis for up to 35 days post-operatively. This prospective cohort study investigated the compliance of 40 consecutive consenting patients undergoing lower limb arthroplasty with self-administration of a recommended subcutaneous chemotherapeutic agent for six weeks after surgery. Compliance was assessed by examination of the patient for signs of injection, number of syringes used, and a self-report diary at the end of the six-week period. A total of 40 patients, 15 men and 25 women, were recruited. One woman was excluded because immediate post-operative complications prevented her participation. Self-administration was considered feasible in 87% of patients (95% confidence interval (CI) 76 to 98) at the time of discharge. Among this group of 34 patients, 29 (85%) were compliant (95% CI 73 to 97). Patients can learn to self-administer subcutaneous injections of thromboprophylaxis, and compliance with extended prophylaxis to six weeks is good.
The lack of a consensus for core health outcomes
that should be reported in clinical research has hampered study design
and evidence synthesis. We report a United Kingdom consensus for
a core outcome set (COS) for clinical trials of patients with a
hip fracture. We adopted a modified nominal group technique to derive consensus
on 1) which outcome domains should be measured, and 2) methods of
assessment. Participants reflected a diversity of perspectives and
experience. They received an evidence synthesis and postal questionnaire
in advance of the consensus meeting, and ranked the importance of
candidate domains and the relevance and suitability of short-listed
measures. During the meeting, pre-meeting source data and questionnaire
responses were summarised, followed by facilitated discussion and
a final plenary session. A COS was determined using a closed voting
system: a 70% consensus was required. Consensus supported a five-domain COS: mortality, pain, activities
of daily living, mobility, and health-related quality of life (HRQL).
Single-item measures of mortality and mobility (indoor/outdoor walking
status) and a generic multi-item measure of HRQL - the EuroQoL EQ-5D
- were recommended. These measures should be included as a minimum
in all hip fracture trials. Other outcome measures should be added
depending on the particular interventions being studied. Cite this article:
