Surgeon and patient reluctance to participate are potential significant barriers to conducting placebo-controlled trials of orthopaedic surgery. Understanding the preferences of orthopaedic surgeons and patients regarding the design of randomized placebo-controlled trials (RCT-Ps) of knee procedures can help to identify what RCT-P features will lead to the greatest participation. This information could inform future trial designs and feasibility assessments. This study used two discrete choice experiments (DCEs) to determine which features of RCT-Ps of knee procedures influence surgeon and patient participation. A mixed-methods approach informed the DCE development. The DCEs were analyzed with a baseline category multinomial logit model.Aims
Methods
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 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
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
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
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
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 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:
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.
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.
