The aims of this study were to report the outcomes of patients with a complex fracture of the lower limb in the five years after they took part in the Wound Healing in Surgery for Trauma (WHIST) trial. The WHIST trial compared negative pressure wound therapy (NPWT) dressings with standard dressings applied at the end of the first operation for patients undergoing internal fixation of a complex fracture of the lower limb. Complex fractures included periarticular fractures and open fractures when the wound could be closed primarily at the end of the first debridement. A total of 1,548 patients aged ≥ 16 years completed the initial follow-up, six months after injury. In this study we report the pre-planned analysis of outcome data up to five years. Patients reported their Disability Rating Index (DRI) (0 to 100, in which 100 = total disability), and health-related quality of life, chronic pain scores and neuropathic pain scores annually, using a self-reported questionnaire. Complications, including further surgery related to the fracture, were also recorded.Aims
Methods
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
There are a number of patients in whom hip preservation surgery is not indicated as they have developed signs of early osteoarthritis, and nor can they have a hip replacement as they are too early in the disease process. The use of PRP in OA of the hip has not been studied systematically and this study concisely collates all the available data in the use of PRP in Hip OA. This systematic review and meta-analysis aimed to assess intra-articular platelet-rich plasma as a therapeutic intervention for hip osteoarthritis, including the duration of efficacy, influence of dose and composition of PRP, and the incidence of adverse effects. We performed literature searches on the MEDLINE, EMBASE, CINHAL, WEB OF SCIENCE, COCHRANE and SCOPUS databases, and PRSIMA guidelines were followed. Data was pooled using random effects meta-analysis. We assessed quality of the included studies using the Methodological Index for Non-Randomised Studies (MINORS) instrument, with an additional assessment for
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
The aim of this study was to determine whether the sequential
application of povidone iodine-alcohol (PVI) followed by chlorhexidine
gluconate-alcohol (CHG) would reduce surgical wound contamination
to a greater extent than PVI applied twice in patients undergoing
spinal surgery. A single-centre, interventional, two arm, parallel group randomised
controlled trial was undertaken, involving 407 patients who underwent
elective spinal surgery. For 203 patients, the skin was disinfected before surgery using
PVI (10% [w/w (1% w/w available iodine)] in 95% industrial denatured
alcohol, povidone iodine; Videne Alcoholic Tincture) twice, and
for 204 patients using PVI once followed by CHG (2% [w/v] chlorhexidine
gluconate in 70% [v/v] isopropyl alcohol; Chloraprep with tint).
The primary outcome measure was contamination of the wound determined
by aerobic and anaerobic bacterial growth from samples taken after
disinfection.Aims
Patients and Methods
Total hip replacement (THR) and total knee replacement (TKR) are usually effective at relieving pain; however, 7–23% of patients experience chronic post-surgical pain. These trials aimed to investigate the effect of local anaesthetic wound infiltration on pain severity at 12 months after primary THR or TKR for osteoarthritis. Between November 2009 and February 2012, 322 patients listed for THR and 316 listed for TKR were recruited into a single-centre double-blind randomised controlled trial. Participants were randomly assigned (1:1) to receive local anaesthetic infiltration and standard care or standard care alone. Participants and outcomes assessors were masked to group allocation. The primary outcome was pain severity on the WOMAC Pain scale at 12 months post-surgery. Analyses were conducted using intention-to-treat and per-protocol approaches. Ethics approval was obtained from Southampton and South West Hampshire Research Ethics Committee.Background
Methods
The subvastus approach has potential early advantages over the medial parapatellar approach because it avoids disruption of the quadriceps tendon. We present a systematic review and meta-analysis of the functional outcomes and complications associated with these two approaches. Following an extensive search of prospective trials published in any language before 1st August 2014, studies were screened in duplicate according to pre-defined inclusion and exclusion criteria. Sixteen randomised controlled trials were included in the meta-analysis comprising of 1,711 total knee replacements. Knee society score and range of movement were significantly superior in the subvastus group at early and one-year follow up. The subvastus approach was also associated with a statistically significant reduction in the requirement for intraoperative lateral release, perioperative blood loss, visual analogue score for pain on day 1 post operatively, and the number of days to achieve active straight leg raising. Both tourniquet time and total operative time were increased for the subvastus approach. There was no statistically significant difference in complications such as stiffness requiring MUA, superficial and deep infection and deep vein thrombosis. The subvastus approach confers a functional advantage over the medial parapatellar approach to the knee which lasts for a minimum of one year postoperatively.
High-quality randomised controlled trials (RCTs)
evaluating surgical therapies are fundamental to the delivery of
evidence-based orthopaedics. Orthopaedic clinical trials have unique
challenges; however, when these challenges are overcome, evidence
from trials can be definitive in its impact on surgical practice.
In this review, we highlight several issues that pose potential
challenges to orthopaedic investigators aiming to perform surgical randomised
controlled trials. We begin with a discussion on trial design issues,
including the ethics of sham surgery, the importance of sample size,
the need for patient-important outcomes, and overcoming expertise
bias. We then explore features surrounding the execution of surgical
randomised trials, including ethics review boards, the importance
of organisational frameworks, and obtaining adequate funding. 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:
Periarticular multimodal drug injection (PMDI) during total knee arthroplasty (TKA) has been reported with promising effects, but some results still remain controversial. Therefore, we conducted a systematic review and meta-analysis based on randomized controlled trials (RCTs) to evaluate the efficiency and safety of PMDI technique in TKA. We systematically conducted an electronic search in the databases of PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science (SCI), and the Chinese Biomedical Literature Database (CBM). Two independent reviewers completed data collection and assessment of methodological quality according to the Cochrane Handbook 5.1. The quality of evidence of outcomes was judged using GRADE criteria. Statistical analysis was performed using the RevMan 5.1 software.Backgroud:
Methods:
Randomised controlled trials (RCT) published in the British volume of the JBJS from United Kingdom based institutes have been analysed to review the level of involvement of junior doctors over the past 25 years (1988 to 2012) which included three different training eras: Pre-Calman (1988 to 1995), Calman (1996 to 2006), and MMC (2007 to 2012). Authors were divided into: Senior doctors, Registrars, Fellows, Senior House Officers/ Foundation Doctors, and Others. The level of involvement has been identified as being first author, senior author or co-author. One hundred and fifty nine RCTs have been identified with a total of 705 authors. Eighty eight registrars, 32 fellows and 19 SHO/ Foundation doctors have been involved in RCT published over the last 25 years (19.7%). Registrars constituted 15% of all authors in the pre-Calman, 12% in the Calman and 11% in the MMC periods. They constituted 33% of all first authors in the pre-Calman, 21% in the Calman, and 12% in the MMC periods. With regards to SHO/ Foundation doctors, they were only 2% of all authors in the pre-Calman, 3% in the Calman, and 4% in the MMC periods. They were not the first author in any RCT in the pre-Calman period, rising to 7% in both the Calman and MMC periods. Our study shows that registrars involvement was at its highest in the pre-Calman era with gradual decline in their involvement in the subsequent training eras. SHO/Foundation doctors involvement remains very low, however showing increasing rate in the MMC era.
Introduction. There is an ever increasing demand for
Cross-linking of polyethylene greatly reduces its wear rate in hip simulator studies. We conducted a systematic review and meta-analysis of randomized controlled trials comparing cross-linked to conventional polyethylene liners for total hip arthroplasty to determine if there is a clinical reduction of: 1) wear rates, 2) radiographic osteolysis, and 3) need for total hip revision. A systematic search of MEDLINE, EMBASE, and COCHRANE databases was conducted from inception to May 2010 for all trials involving the use of cross-linked polyethylene for total hip arthroplasty. Eligibility for inclusion in the review was: use of a random allocation of treatments; a treatment arm receiving cross-linked polyethylene and a treatment arm receiving conventional polyethylene for total hip arthroplasty; and use of radiographic wear as an outcome measure. Eligible studies were obtained and read in full by two co-authors who then independently applied the Checklist to Evaluate a Report of a Nonpharmacological Trial to each study. Pooled mean differences were calculated for the following continuous outcomes: bedding-in, linear wear rate, three dimensional linear wear rate, volumetric wear rate, and total linear wear. Pooled risk ratios were calculated for radiographic osteolysis and revision hip arthroplasty.Purpose
Method
To analyse procedural details - specifically vertebral levels treated and injected polymethylmethacrylate (PMMA) volumes - of the publications by Buchbinder et al. 1 and Kallmes et al. 2 in the context of best available basic science. Review Two randomised controlled trials published by the New England Journal of Medicine (NEJM) in 2009 comparing vertebroplasty to sham procedures conclude vertebroplasty to be no more effective than injection of local anaesthetic. This finding contradicts previous publications showing clinical efficacy. Neither investigation provides a breakdown of vertebral levels treated (original publication and supplementary material). Only one investigation provides information on fill volumes with average of 2.8 ml +/− 1.2 ml SD. The available basic science indicates a minimum fill volume of 13-16% of the vertebral body volume to be necessary for a relevant biomechanical effect on restoration of vertebral strength, according to which only vertebrae of the upper to mid thoracic spine could reasonably have received a biomechanically effective fill with the declared average volume of 2.8 ml +/− 1.2 ml SD. The available data of the NEJM publications strongly indicates that the treatment arm includes insufficiently treated patients. The technical information provided by the NEJM publications is insufficient to conclusively prove or disprove the clinical efficacy of vertebroplasty.
To investigate the effectiveness of surgical fusion for chronic low back pain (CLBP) compared to non-surgical intervention, databases were searched from 1966-2005. The meta-analysis was based on the mean difference in Oswestry Disability Index (ODI) change from baseline to follow-up. Four studies were eligible (634 patients). The pooled mean difference in ODI was 4.13 in favour of surgery (95% CI: -0.82-9.08; p=0.10; I2=44.4%). Surgery was associated with a 16% pooled rate of complication (95% CI: 12-20%, I2=0%). The cumulative evidence does not support surgical fusion for CLBP due to the marginal improvement in ODI which is of minimal clinical importance.
Midvastus (MV) vs Medial Parapatellar (MPP) approach: Quadriceps function in the early post operative period was better preserved in the MV group. Post operative pain, blood loss and the need for LRR tended to be lower in the MV group. Subvastus (SV) vs Medial Parapatellar approach: Quadriceps function was better preserved in the SV group up to 3 months post operatively. ROM was generally greater up until the 4 week time point. Post operative pain and blood loss was lower in the SV group. Midvastus vs Subvastus approach: The SV group suffered with significantly more pain at six months post operatively. Quadriceps-sparing versus Medial Parapatellar Approach: Significantly longer operative times and more complications were noted in the QS group. Modified ‘Quadriceps sparing’ Medial Parapatellar vs Mini-Subvastus (MSV) approach: A tendency for earlier restoration of SLR and better early ROM was noted in the MSV group.
MIS tends to result in an improved early quadriceps function and decreased blood loss. However, these approaches are technically more demanding, result in longer operative times and provide no long-term benefit. There is concern that they result in a greater number of major complications and risk implant mal-alignment. Eversion of the patella seems to correlate with poor quadriceps function.
Midvastus vs Medial Parapatellar approach: Quadriceps function in the early post operative period was better preserved in the MV group. Post operative pain, blood loss and the need for LRR tended to be lower in the MV group. There was no difference in ROM, hospital stay, knee scores, complications or radiological alignment. Subvastus vs Medial Parapatellar approach: Quadriceps function was better preserved in the SV group up to 3 months post operatively. ROM was generally greater up to the 4 week time point. Post operative pain and blood loss was lower in the SV group. There was no difference in operative/tourniquet time, hospital stay, rate of LRR, or complications. Modified “Quadriceps sparing” Medial Parapatellar vs Mini-Subvastus (MSV) approach: A tendency for earlier restoration of SLR and better early ROM was noted in the MSV group. Midvastus vs Subvastus approach: The SV group suffered with significantly more pain at six months post operatively.
The promotion and practice of evidence-based medicine necessitates a critical evaluation of medical literature including the “gold standard” of randomised clinical trials. Recent studies have examined the quality of randomised clinical trials in various surgical specialties, but no study has focused on pediatric orthopedics. The purpose of this study was to assess and describe the quality of randomised clinical trials published in the last ten years in journals with high clinical impact in pediatric orthopaedics. All of the randomised clinical trials in pediatric orthopedics published in five well-recognised journals between 1995–2005 were reviewed using the Detsky Quality Assessment Scale. The mean percentage score on the Detsky Scale was 53% (95% CI: 46%–60%). Only seven (19%) of the articles satisfied the threshold for a satisfactory level of methodologic quality (Detsky >
75%). The majority of randomised clinical trials in pediatric orthopedics that are published in well-recognised, peer-reviewed journals demonstrate substantial deficiencies in methodologic quality. Particular areas of weakness include inadequate rigor and reporting of randomization methods, use of inappropriate or poorly-described outcome measures, inadequate description of inclusion and exclusion criteria and inappropriate statistical analysis. Further efforts are necessary to improve the conduct and reporting of clinical trials in this field in order to avoid inadvertent misinformation of the clinical community.
