There is an urgent need for the staged, controlled, introduction of new technology and new procedures to surgery. A classification system in four stages is proposed, which would allow for prospective assessment of new devices or methods before they are released for use by the surgical community. The proposal recognises the unique nature of a surgical operation and its learning curve. The issues of randomisation and of informed consent are discussed, and are shown not to be barriers to
A study was made of the mechanics of blood-bearing in a series of patients treated with a cast-brace for fracture of the distal femur. Knee hinges incorporating strain-gauges, a simple force-plate on the floor and a standardised weight-bearing test were used to record axial loads through the cast-brace itself and through the fracture during the phases of healing. The cast-brace carried loads of only 10 to 20 per cent of body weight and functioned mainly as an antibuckling hinged tube. Patterns of weight-bearing recovery showed that the fracture itself limited loads to safe levels. A measure of the recovery of strength at the fracture was determined and termed the "fracture load index". Graphs obtained in this way demonstrated four biomechanical phases of bony union which correlated well with the stages of clinical healing. The clinical application of these results have led to improvements in the design of braces and the use of a cylinder cast-brace for fractures of the distal half of the femoral shaft and of a new type of brace with a hinge at the hip attached to the thigh cast for fractures of the proximal shaft. A simple
Cost is a factor in the choice of prosthetic components in joint replacement. For a given performance, the least expensive components are the most cost-effective. When evaluating a new prosthesis with an unknown outcome, the use of an economic model allows estimation of potential cost-effectiveness. We used published data for the survival of cemented total hip replacements from Sweden, and cost and demographic information from New South Wales, Australia, in such a model. In young active total hip recipients a new prosthetic design which offered a 90% improvement in survivorship over 15 years and a 15% reduction in the cost of revision surgery, could be sold at a price of 2 to 2.5 times that of conventional cemented components such as the Charnley Low Friction Arthroplasty and still be cost-effective. Using more likely estimates of the improved performance of new technology, however, the upper limit of cost-effectiveness is an increase of 1.5 to 1. Only a very small increase in the cost of a prosthesis could ever be justified for older patients of either sex. Most of the potential benefits of a better level of survivorship appear towards the end of the 15-year period. The results of modelling may be incorporated in
We studied the safety of combining the postoperative use of a non-steroidal anti-inflammatory drug with low-dose heparin. In a double-blind, placebo-controlled
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:
To compare the functionality of adults with displaced mid-shaft clavicular fractures treated either operatively or nonoperatively and to compare the relative risk of nonunion and reoperation between the two groups. Based on specific eligibility criteria, 120 adults (median age 37.5 years (interquartile range (18 to 61)) and 84% males (n = 101)) diagnosed with an acute displaced mid-shaft fracture were recruited, and randomized to either the operative (n = 60) or nonoperative (n = 60) treatment group. This randomized controlled, partially blinded trial followed patients for 12 months following initial treatment. Functionality was assessed by the Constant score (CS) (assessor blinded to treatment) and Disability of the Arm, Shoulder and Hand (DASH) score. Clinical and radiological evaluation, and review of patient files for complications and reoperations, were added as secondary outcomes.Aims
Methods
The aim of this study was to explore whether time to surgery affects functional outcome in displaced proximal humeral fractures A total of 250 patients presenting within three weeks of sustaining a displaced proximal humeral fracture involving the surgical neck were recruited at 32 acute NHS hospitals in the United Kingdom between September 2008 and April 2011. Of the 125 participants, 109 received surgery (fracture fixation or humeral head replacement) as per randomization. Data were included for 101 and 67 participants at six-month and five-year follow-up, respectively. Oxford Shoulder Scores (OSS) collected at six, 12, and 24 months and at three, four, and five years following randomization was plotted against time to surgery. Long-term recovery was explored by plotting six-month scores against five-year scores and agreement was illustrated with a Bland-Altman plot.Aims
Methods
Recent studies of nonoperatively treated displaced midshaft clavicular fractures have shown a high incidence of nonunion and unsatisfactory functional outcome. Some studies have shown superior functional results and higher rates of healing following operative treatment. The aim of this study was to compare the outcome in these patients after nonoperative management with those treated with fixation. In a multicentre, parallel randomized controlled trial, 146 adult patients with an acute displaced fracture of the midthird of the clavicle were randomized to either nonoperative treatment with a sling (71, 55 men and 16 women with a mean age of 39 years, 18 to 60) or fixation with a pre-contoured plate and locking screws (75, 64 men and 11 women with a mean age of 40 years, 18 to 60). Outcome was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) Score, the Constant Score, and radiographical evidence of union. Patients were followed for one year.Aims
Patients and Methods
Pin-site infection remains a significant problem for patients treated by external fixation. A randomized trial was undertaken to compare the weekly use of alcoholic chlorhexidine (CHX) for pin-site care with an emollient skin preparation in patients with a tibial fracture treated with a circular frame. Patients were randomized to use either 0.5% CHX or Dermol (DML) 500 emollient pin-site care. A skin biopsy was taken from the tibia during surgery to measure the dermal and epidermal thickness and capillary, macrophage, and T-cell counts per high-powered field. The pH and hydration of the skin were measured preoperatively, at follow-up, and if pin-site infection occurred. Pin-site infection was defined using a validated clinical system.Aims
Methods
The aim of this study was to compare the incidence of anterior knee pain after antegrade tibial nailing using suprapatellar and infrapatellar surgical approaches A total of 95 patients with a tibial fracture requiring an intramedullary nail were randomized to treatment using a supra- or infrapatellar approach. Anterior knee pain was assessed at four and six months, and one year postoperatively, using the Aberdeen Weightbearing Test – Knee (AWT-K) score and a visual analogue scale (VAS) score for pain. The AWT-K is an objective patient-reported outcome measure that uses weight transmitted through the knee when kneeling as a surrogate for anterior knee pain.Aims
Patients and Methods
The aim of this study was to compare the effect of a percutaneous
radiofrequency heat lesion at the medial branch of the primary dorsal
ramus with a sham procedure, for the treatment of lumbar facet joint
pain. A randomised sham-controlled double blind multicentre trial was
carried out at the multidisciplinary pain centres of two hospitals.
A total of 60 patients aged >
18 years with a history and physical
examination suggestive of facet joint pain and a decrease of ≥ 2
on a numerical rating scale (NRS 0 to 10) after a diagnostic facet
joint test block were included. In the treatment group, a percutaneous
radiofrequency heat lesion (80oC during 60 seconds per
level) was applied to the medial branch of the primary dorsal ramus.
In the sham group, the same procedure was undertaken without for
the radiofrequency lesion. Both groups also received a graded activity
physiotherapy programme. The primary outcome measure was decrease
in pain. A secondary outcome measure was the Global Perceived Effect scale
(GPE).Aims
Patients and Methods
Surgical treatment of hip fracture is challenging; the bone is porotic and fixation failure can be catastrophic. Novel implants are available which may yield superior clinical outcomes. This study compared the clinical effectiveness of the novel X-Bolt Hip System (XHS) with the sliding hip screw (SHS) for the treatment of fragility hip fractures. We conducted a multicentre, superiority, randomized controlled trial. Patients aged 60 years and older with a trochanteric hip fracture were recruited in ten acute UK NHS hospitals. Participants were randomly allocated to fixation of their fracture with XHS or SHS. A total of 1,128 participants were randomized with 564 participants allocated to each group. Participants and outcome assessors were blind to treatment allocation. The primary outcome was the EuroQol five-dimension five-level health status (EQ-5D-5L) utility at four months. The minimum clinically important difference in utility was pre-specified at 0.075. Secondary outcomes were EQ-5D-5L utility at 12 months, mortality, residential status, mobility, revision surgery, and radiological measures.Aims
Methods
A group of 109 patients with unilateral low back pain for over three months were randomised to receive one of three types of injection treatment: cortisone and local anaesthetic injected into two facet joints (28), the same mixture around two facet joints (39), or physiological saline into two facet joints (42). The effect of the treatment was evaluated in relation to work attendance, pain, disability and movements of the lumbar spine. Patients were examined one hour and two and six weeks after treatment and also completed a questionnaire after three months. A significant improvement was observed in work attendance, pain and disability scores, but this was independent of the treatment given and movements of the lumbar spine were not improved. Of the 70 patients with initial pain relief after injection, 36% reported persisting benefit at the three month follow-up, independent of the mode of treatment given. We conclude that facet joint injection is a non-specific method of treatment and the good results depend on a tendency to spontaneous regression and to the psychosocial aspects of back pain.
1. A systematic collection of the clinical findings in fifty patients with pyrophosphate synovitis,among some 300 patients with obscure disorder of the knee, has been made over a period of eighteen months. The numbers of men and women were equal, the mean age being seventy years (range thirty-seven to ninety), and the mean age at the onset of symptoms fifty-nine years. 2. A difference in the clinical picture between the sexes was found. In men an acute synovitis predominated, in women chronic joint complaints. 3. A high incidence of accompanying disease was found, but none had a significant relationship to the arthropathy, although the high frequency (20 per cent) of synovitis following an acute severe illness of some other kind was striking. 4. No specific radiological sign except for calcifications in articular cartilage and menisci was found in these patients, and no relationship to osteoarthrosis could be established. 5. The great variability of symptoms and the surprisingly high incidence attracts attention to pyrophosphate synovitis as a cause of joint symptoms, especially in elderly patients.
