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:
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:
Evidence -based medicine (EBM) is designed to inform clinical decision-making within all medical specialties, including orthopaedic surgery. We recently published a pilot survey of the Canadian Orthopaedic Association (COA) membership and demonstrated that the adoption of EBM principles is variable among Canadian orthopaedic surgeons. The objective of this study was to conduct a broader international survey of orthopaedic surgeons to identify characteristics of research studies perceived as being most influential in informing clinical decision-making. A 29-question electronic survey was distributed to the readership of an established orthopaedic journal with international readership. The survey aimed to analyse the influence of both extrinsic (journal quality, investigator profiles, etc.) and intrinsic characteristics (study design, sample size, etc.) of research studies in relation to their influence on practice patterns.Objectives
Materials and Methods
An extensive review of the spinal and arthroplasty
literature was undertaken to evaluate the effectiveness of local
antibiotic irrigation during surgery. The efficacy of antibiotic
irrigation for the prevention of acute post-operative infection
after total joint arthroplasty was evaluated retrospectively in
2293 arthroplasties (1990 patients) between January 2004 and December
2013. The mean follow-up was 73 months (20 to 139). One surgeon
performed all the procedures with minimal post-operative infection. The intra-operative protocol included an irrigation solution
of normal saline with vancomycin 1000 mg/l and polymyxin 250 000
units/l at the rate of 2 l per hour. No patient required re-admission
for primary infection or further antibiotic treatment. Two morbidly obese
patients (two total hip arthroplasties) developed subcutaneous fat
necrosis requiring debridement and one was revised because the deep
capsular sutures were contaminated by the draining subcutaneous
haematoma. One patient who had undergone total knee arthroplasty
had unrecognised damage to the lateral superior geniculate artery
and developed a haematoma that became infected secondarily four
months after the surgery and underwent revision. The use of antibiotic irrigation during arthroplasty surgery
has been highly effective for the prevention of infection in the
author’s practice. However, it should be understood that any routine
prophylactic use of antibiotics may result in resistant organisms,
and the wise stewardship of the use of antibiotics is an important
part of surgical practice. Cite this article:
The ‘jumbo’ acetabular component is now commonly
used in acetabular revision surgery where there is extensive bone
loss. It offers high surface contact, permits weight bearing over
a large area of the pelvis, the need for bone grafting is reduced
and it is usually possible to restore centre of rotation of the
hip. Disadvantages of its use include a technique in which bone
structure may not be restored, a risk of excessive posterior bone
loss during reaming, an obligation to employ screw fixation, limited
bone ingrowth with late failure and high hip centre, leading to increased
risk of dislocation. Contraindications include unaddressed pelvic
dissociation, inability to implant the component with a rim fit,
and an inability to achieve screw fixation. Use in acetabulae with
<
50% bone stock has also been questioned. Published results
have been encouraging in the first decade, with late failures predominantly because
of polyethylene wear and aseptic loosening. Dislocation is the most
common complication of jumbo acetabular revisions, with an incidence
of approximately 10%, and often mandates revision. Based on published results,
a hemispherical component with an enhanced porous coating, highly
cross-linked polyethylene, and a large femoral head appears to represent
the optimum tribology for jumbo acetabular revisions. Cite this article:
The December 2015 Spine Roundup360 looks at: Ketamine in scoliosis surgery; Teriparatide in osteoporotic spinal fractures; Trabecular metal in the spine?; Revision surgery a SPORTing chance?; The course of degenerative lumbar spondylolisthesis; Hip or lumbar spine: a common conundrum
The purpose of this study was to evaluate the
effect of various non-operative modalities of treatment (transcutaneous
electrical nerve stimulation (TENS); neuromuscular electrical stimulation
(NMES); insoles and bracing) on the pain of osteoarthritis (OA)
of the knee. We conducted a systematic review according to the Preferred Reporting
Items for Systematic Reviews and Meta-Analyses guidelines to identify
the therapeutic options which are commonly adopted for the management
of osteoarthritis (OA) of the knee. The outcome measurement tools used in the different studies were
the visual analogue scale and The Western Ontario and McMaster Universities
Arthritis Index pain index: all pain scores were converted to a
100-point scale. A total of 30 studies met our inclusion criteria: 13 on insoles,
seven on TENS, six on NMES, and four on bracing. The standardised
mean difference (SMD) in pain after treatment with TENS was 1.796,
which represented a significant reduction in pain. The significant
overall effect estimate for NMES on pain was similar to that of
TENS, with a SMD of 1.924. The overall effect estimate of insoles
on pain was a SMD of 0.992. The overall effect of bracing showed
a significant reduction in pain of 1.34. Overall, all four non-operative modalities of treatment were
found to have a significant effect on the reduction of pain in OA
of the knee. This study shows that non-operative physical modalities of treatment
are of benefit when treating OA of the knee. However, much of the
literature reviewed evaluates studies with follow-up of less than
six months: future work should aim to evaluate patients with longer
follow-up. Cite this article:
The October 2015 Knee Roundup360 looks at: Allergy and outcome in arthroplasty; Physiotherapy and drains not such a bad combination?; Another nail in the coffin for arthroscopists?; Graft precondition hocus pocus; Extended dose steroids in knee arthritis?; Indolent peri-prosthetic infection; Computer modelling and medial knee arthritis
The October 2015 Wrist &
Hand Roundup360 looks at: Base of thumb arthritis – steroids not a waste of time; De Quervain’s tenosynovitis and steroids; Use your therapy time wisely!; Excision osteotomy for the carpometacarpal joint?; CORDLESS at five years?; Arthroscopy again of no benefit?; Distal radius stirring up trouble again!; Scaphoid arthroscopy under the spotlight
The National Institute for Health and Clinical
Excellence (NICE) has thus far relied on historical data and predominantly
industry-sponsored trials to provide evidence for venous thromboembolic
(VTE) prophylaxis in joint replacement patients. We argue that the
NICE guidelines may be reliant on assumptions that are in need of
revision. Following the publication of large scale, independent
observational studies showing little difference between low-molecular-weight
heparins and aspirin, and recent changes to the guidance provided
by other international bodies, should NICE reconsider their recommendations? Cite this article:
We investigated whether the presence of a pathological
fracture increased the risk of local recurrence in patients with
a giant cell tumour (GCT) of bone. We also assessed if curettage
is still an appropriate form of treatment in the presence of a pathological
fracture. We conducted a comprehensive review and meta-analysis
of papers which reported outcomes in patients with a GCT with and
without a pathological fracture at presentation. We computed the
odds ratio (OR) of local recurrence in those with and without a
pathological fracture. We selected 19 eligible papers for final analysis. This included
3215 patients, of whom 580 (18.0%) had a pathological fracture.
The pooled OR for local recurrence between patients with and without
a pathological fracture was 1.05 (95% confidence interval (CI) 0.66
to 1.67, p = 0.854). Amongst the subgroup of patients who were treated with
curettage, the pooled OR for local recurrence was 1.23 (95% CI 0.75
to 2.01, p = 0.417). A There is no difference in local recurrence rates between patients
who have a GCT of bone with and without a pathological fracture
at the time of presentation. The presence of a pathological fracture
should not preclude the decision to perform curettage as carefully
selected patients who undergo curettage can have similar outcomes
in terms of local recurrence to those without such a fracture. Cite this article:
The October 2015 Trauma Roundup360 looks at: PCA not the best in resuscitation; Impact of trauma centre care; Quality of life after a hip fracture; Recovery and severity of injury: open tibial fractures in the spotlight; Assessment of the triplane fractures; Signs of an unstable paediatric pelvis; Safe insertion of SI screws: are two views required?; Post-operative delirium under the spotlight; Psychological effects of fractures; K-wires cost effective in DRAFFT
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:
A new generation of knee prostheses has been introduced with the intention of improving post-operative knee flexion. In order to evaluate whether this goal has been achieved we performed a systematic review and meta-analysis. Systematic literature searches were conducted on MEDLINE and EMBASE from their inception to December 2007, and proceedings of scientific meetings were also searched. Only randomised, clinical trials were included in the meta-analysis. The mean difference in the maximum post-operative flexion between the ‘high-flex’ and conventional types of prosthesis was defined as the primary outcome measure. A total of five relevant articles was identified. Analysis of these trials suggested that no clinically relevant or statistically significant improvement was obtained in flexion with the ‘high-flex’ prostheses. The weighted mean difference was 2.1° (95% confidence interval −0.2 to +4.3; p = 0.07).
The August 2015 Wrist &
Hand Roundup360 looks at: Scaphoid screws out?; Stiff fingers under the spotlight; Trigger finger: is complexity needed?; Do we really need to replace the base of the thumb?; Scapholunate ligament injuries and their treatment: a missed research opportunity?; Proximal row carpectomy
To date, there is insufficient evidence available to compare
the outcome of cemented and uncemented fixation of the humeral stem
in reverse shoulder arthroplasty (RSA). A systemic review comprising 41 clinical studies was performed
to compare the functional outcome and rate of complications of cemented
and uncemented stems in RSA. These included 1455 cemented and 329
uncemented shoulders. The clinical characteristics of the two groups
were similar. Variables were compared using pooled frequency-weighted means
and relative risk ratios (RR).Aims
Methods