The aim of this study was to review the role
of clinical trial networks in orthopaedic surgery. A total of two
electronic databases (MEDLINE and EMBASE) were searched from inception
to September 2013 with no language restrictions. Articles related
to randomised controlled trials (RCTs), research networks and orthopaedic
research, were identified and reviewed. The usefulness of trainee-led
research collaborations is reported and our knowledge of current
clinical trial infrastructure further supplements the review. Searching
yielded 818 titles and abstracts, of which 12 were suitable for
this review. Results are summarised and presented narratively under
the following headings: 1) identifying clinically relevant research
questions; 2) education and training; 3) conduct of multicentre
RCTs and 4) dissemination and adoption of trial results. This review
confirms growing international awareness of the important role research
networks play in supporting trials in orthopaedic surgery. Multidisciplinary
collaboration and adequate investment in trial infrastructure are crucial
for successful delivery of RCTs. Cite this article:
The “Universal Protocol” (UP) was launched as a regulatory compliance standard by the Joint Commission on 1st July 1 2004, with the primary intent of reducing the occurrence of wrong-site and wrong-patient surgery. As we’re heading into the tenth year of the UP implementation in the United States, it is time for critical assessment of the protocol’s impact on patient safety related to the incidence of preventable never-events. This article opens the debate on the potential shortcomings and pitfalls of the UP, and provides recommendations on how to circumvent specific inherent vulnerabilities of this widely established patient safety protocol.
Trauma and orthopaedics is the largest of the
surgical specialties and yet attracts a disproportionately small
fraction of available national and international funding for health
research. With the burden of musculoskeletal disease increasing,
high-quality research is required to improve the evidence base for
orthopaedic practice. Using the current research landscape in the
United Kingdom as an example, but also addressing the international
perspective, we highlight the issues surrounding poor levels of
research funding in trauma and orthopaedics and indicate avenues
for improving the impact and success of surgical musculoskeletal
research. Cite this article:
Improvements in the surgical technique of total
knee replacement (TKR) are continually being sought. There has recently
been interest in three-dimensional (3D) pre-operative planning using
magnetic resonance imaging (MRI) and CT. The 3D images are increasingly
used for the production of patient-specific models, surgical guides
and custom-made implants for TKR. The users of patient-specific instrumentation (PSI) claim that
they allow the optimum balance of technology and conventional surgery
by reducing the complexity of conventional alignment and sizing
tools. In this way the advantages of accuracy and precision claimed
by computer navigation techniques are achieved without the disadvantages
of additional intra-operative inventory, new skills or surgical
time. This review describes the terminology used in this area and debates
the advantages and disadvantages of PSI.
We report on the use of the Ilizarov method to
treat 40 consecutive fractures of the tibial shaft (35 AO 42C fractures and
five AO 42B3 fractures) in adults. There were 28 men and
12 women with a mean age of 43 years (19 to 81). The series included
19 open fractures (six Gustilo grade 3A and 13 grade 3B) and 21
closed injuries. The mean time from injury to application of definitive
Ilizarov frame was eight days (0 to 35) with 36 fractures successfully
uniting without the need for any bone-stimulating procedure. The
four remaining patients with nonunion healed with a second frame.
There were no amputations and no deep infections. None required
intervention for malunion. The total time to healing was calculated
from date of injury to removal of the frame, with a median of 166
days (mean 187, (87 to 370)). Minor complications included snapped
wires in two patients and minor pin-site infections treated with
oral antibiotics in nine patients (23%). Clinical scores were available
for 32 of the 40 patients at a median of 55 months (mean 62, (26
to 99)) post-injury, with ‘good’ Olerud and Molander ankle scores
(median 80, mean 75, (10 to 100)), ‘excellent’ Lysholm knee scores
(median 97, mean 88, (29 to 100)), a median Tegner activity score
of 4 (mean 4, (0 to 9)) (comparable to ‘moderately heavy labour
/ cycling and jogging’) and Short Form-12 scores that exceeded the
mean of the population as a whole (median physical component score
55 (mean 51, (20 to 64)), median mental component score 57 (mean
53, (21 to 62)). In conclusion, the Ilizarov method is a safe and
reliable way of treating complex tibial shaft fractures with a high
rate of primary union.
We performed a systematic review and meta-analysis
to compare the efficacy of intermittent mechanical compression combined
with pharmacological thromboprophylaxis, against either mechanical
compression or pharmacological prophylaxis in preventing deep-vein
thrombosis (DVT) and pulmonary embolism in patients undergoing hip
or knee replacement. A total of six randomised controlled trials,
evaluating a total of 1399 patients, were identified. In knee arthroplasty,
the rate of DVT was reduced from 18.7% with anticoagulation alone
to 3.7% with combined modalities (risk ratio (RR) 0.27, p = 0.03;
number needed to treat: seven). There was moderate, albeit non-significant,
heterogeneity (I2 = 42%). In hip replacement, there was
a non-significant reduction in DVT from 8.7% with mechanical compression
alone to 7.2% with additional pharmacological prophylaxis (RR 0.84)
and a significant reduction in DVT from 9.7% with anticoagulation
alone to 0.9% with additional mechanical compression (RR 0.17, p
<
0.001; number needed to treat: 12), with no heterogeneity (I2 =
0%). The included studies had insufficient power to demonstrate
an effect on pulmonary embolism. We conclude that the addition of intermittent mechanical leg
compression augments the efficacy of anticoagulation in preventing
DVT in patients undergoing both knee and hip replacement. Further
research on the role of combined modalities in thromboprophylaxis
in joint replacement and in other high-risk situations, such as fracture
of the hip, is warranted.
Excision of a physeal bar and filling the space with interposition material may allow resumption of normal growth. Both the extent and the location of the bar and the amount of growth remaining from physis must be determined. Computer-assisted surgery is being used increasingly in various fields of orthopaedics. We describe the management of a patient with premature physeal arrest of the right distal tibia in which resection of a physeal bar was achieved under real-time three-dimensional intra-operative monitoring by computer-assisted navigation. The advantage of this method over other means of imaging is that intra-operative identification can increase the accuracy of resection of the bar.
Antiplatelet agents are widely prescribed for the primary and secondary prevention of cardiovascular events. A common clinical problem facing orthopaedic and trauma surgeons is how to manage patients receiving these agents who require surgery, either electively or following trauma. The dilemma is to balance the risk of increased blood loss if the antiplatelet agents are continued peri-operatively against the risk of coronary artery/stent thrombosis and/or other vascular event if the drugs are stopped. The traditional approach of stopping these medications up to two weeks before surgery appears to pose significant danger to patients and may require review. This paper covers the important aspects regarding the two most commonly prescribed antiplatelet agents, aspirin and clopidogrel.
Modern principles for the treatment of open fractures include stabilisation of the bone and management of the soft tissues. Wound debridement and irrigation is thought to be the mainstay in reducing the incidence of infection. Although numerous studies on animals and humans have focused on the type of irrigation performed, little is known of the factors which influence irrigation. This paper evaluates the evidence, particularly with regard to additives and the mode of delivery of irrigation fluid. Normal saline should be used and although many antiseptics and antibiotics have been employed, no consensus has been reached as to the ideal additive. Despite the advocates of high-pressure methods highlighting the improved dilutional ability of such techniques, the results are inconclusive and these irrigation systems are not without complications. New systems for debridement are currently being investigated, and an ideal method has yet to be determined.
Between March 1994 and June 2003, 80 patients with brachial plexus palsy underwent a trapezius transfer. There were 11 women and 69 men with a mean age of 31 years (18 to 69). Before operation a full evaluation of muscle function in the affected arm was carried out. A completely flail arm was found in 37 patients (46%). Some peripheral function in the elbow and hand was seen in 43 (54%). No patient had full active movement of the elbow in combination with adequate function of the hand. Patients were followed up for a mean of 2.4 years (0.8 to 8). We performed the operations according to Saha’s technique, with a modification in the last 22 cases. We demonstrated a difference in the results according to the pre-operative status of the muscles and the operative technique. The transfer resulted in an increase of function in all patients and in 74 (95%) a decrease in multidirectional instability of the shoulder. The mean increase in active abduction was from 6° (0 to 45) to 34° (5 to 90) at the last review. The mean forward flexion increased from 12° (0 to 85) to 30° (5 to 90). Abduction (41°) and especially forward flexion (43°) were greater when some residual function of the pectoralis major remained (n = 32). The best results were achieved in those patients with most pre-operative power of the biceps, coracobrachialis and triceps muscles (n = 7), with a mean of 42° of abduction and 56° of forward flexion. Active abduction (28°) and forward flexion (19°) were much less in completely flail shoulders (n = 34). Comparison of the 19 patients with the Saha technique and the 15 with the modified procedure, all with complete paralysis, showed the latter operation to be superior in improving shoulder stability. In all cases a decrease in instability was achieved and inferior subluxation was abolished. The results after trapezius transfer depend on the pre-operative pattern of paralysis and the operative technique. Better results can be achieved in patients who have some function of the biceps, coracobrachialis, pectoralis major and triceps muscles compared with those who have a complete palsy. A simple modification of the operation ensures a decrease in joint instability and an increase in function.