Although the importance of sound statistical principles in the design and analysis of data has gained prominence in recent years, biostatistics, the application of statistics to the analysis of biological and medical data, is still a subject which is poorly understood and often mishandled. This review introduces, in the context of orthopaedic research, the terminology and the principles involved in simple data analysis, and outlines areas of medical statistics that have gained prominence in recent years. It also lists and provides an insight into some of the more common errors that occur in published orthopaedic journals and which are frequently encountered at the review stage in papers submitted to the
We present a series of 48 patients with infected total knee replacements managed by the use of articulating cement spacers and short-term parenteral antibiotic therapy in the postoperative period. All patients had microbiological and/or histological confirmation of infection at the first stage of their revision. They all underwent re-implantation and had a mean follow-up of 48.5 months (26 to 85). Infection was successfully eradicated in 42 of the 48 patients (88%). Six had persistent infection which led to recurrence of symptoms and further surgery was successful in eliminating infection in four patients. These rates of success are similar to those of other comparable series. We conclude that protracted courses of intravenous antibiotic treatment may not be necessary in the management of the infected total knee replacement. In addition, we analysed the microbiological, histological and serological results obtained at the time of re-implantation of the definitive prosthesis, but could not identify a single test which alone would accurately predict a successful outcome.
This prospective study evaluates the role of new laboratory markers in the diagnosis of deep implant infection in 78 patients (41 men and 37 women) with a revision total knee or hip replacement. The mean age at the time of operation was 64.0 years (19 to 90). Intra-operative cultures showed that 21 patients had a septic and 57 an aseptic total joint replacement. The white blood cell count, the erythrocyte sedimentation rate and levels of C-reactive protein, interleukin-6, procalcitonin and tumour necrosis factor (TNF)-α were measured in blood samples before operation. The diagnostic cut-off values were determined by Received Operating Characteristic curve analysis. C-reactive protein (>
3.2 md/dl) and interleukin-6 (>
12 pg/ml) have the highest sensitivity (0.95). Interleukin-6 is less specific than C-reactive protein (0.87 The combination of C-reactive protein and interleukin-6 measurement provide excellent screening tests for infection of a deep implant. A highly specific marker such as procalcitonin and pre-operative aspiration of the joint might be useful in identifying patients with true positive C-reactive protein and/or interleukin-6 levels.
The October 2012 Hip &
Pelvis Roundup360 looks at: diagnosing the infected hip replacement; whether tranexamic acid has a low complication rate; the relationship between poor cementing technique and early failure of resurfacing; debridement and retention for the infected replacement; triple-tapered stems and bone mineral density; how early discharge can be bad for your sleep; an updated QFracture algorithm to predict the risk of an osteoporotic fracture; and local infiltration analgesia and total hip replacement.
The August 2012 Trauma Roundup360 looks at: pelvic fractures, thromboembolism and the Japanese; venous thromboembolism risk after pelvic and acetabular fractures; the displaced clavicular fracture; whether to use a nail or plate for the displaced fracture of the distal tibia; the dangers of snowboarding; how to predict the outcome of lower leg blast injuries; compressive external fixation for the displaced patellar fracture; broken hips in Morocco; and spinal trauma in mainland China.
We evaluated triple-phase bone scintigraphy in the differential diagnosis of peri-prosthetic infection in 46 patients with a total hip replacement or bipolar hemiarthroplasty who were due for revision surgery. There were 18 men and 28 women, with a mean age at operation of 64.6 years (28 to 81). We defined peri-prosthetic infection as an increased uptake of radioisotope in all the phases of triple-phase bone scintigraphy and validated these results against the histological and/or microbiology results in every case. The positive and negative predictive values for the presence of infection were 83% and 93%, respectively. The diagnostic sensitivity was 88% and the specificity was 90%. This study indicates that triple-phase bone scintigraphy is a useful tool in the detection of peri-prosthetic infection and offers a cost-effective method of screening.
Evaluation of patients with painful total knee replacement requires a thorough clinical examination and relevant investigations in order to reach a diagnosis. Awareness of the common and uncommon problems leading to painful total knee replacement is useful in the diagnostic approach. This review article aims to act as a guide to the evaluation of patients with painful total knee replacement.
This review summarises the opinions and conclusions
reached from a symposium on infected total knee replacement (TKR)
held at the British Association of Surgery of the Knee (BASK) annual
meeting in 2011. The National Joint Registry for England and Wales
reported 5082 revision TKRs in 2010, of which 1157 (23%) were caused
by infection. The diagnosis of infection beyond the acute post-operative
stage relies on the identification of the causative organism by
aspiration and analysis of material obtained at arthroscopy. Ideal
treatment then involves a two-stage surgical procedure with extensive
debridement and washout, followed by antibiotics. An articulating
or non-articulating drug-eluting cement spacer is used prior to
implantation of the revision prosthesis, guided by the serum level
of inflammatory markers. The use of a single-stage revision is gaining popularity
and we would advocate its use in certain patients where the causative
organism is known, no sinuses are present, the patient is not immunocompromised,
and there is no radiological evidence of component loosening or
osteitis. It is our opinion that single-stage revision produces high-quality
reproducible results and will soon achieve the same widespread acceptance
as it does in infected hip arthroplasty.
Post-discharge surveillance of surgical site infection is necessary if accurate rates of infection following surgery are to be available. We undertook a prospective study of 376 knee and hip replacements in 366 patients in order to estimate the rate of orthopaedic surgical site infection in the community. The inpatient infection was 3.1% and the post-discharge infection rate was 2.1%. We concluded that the use of telephone interviews of patients to identify the group at highest risk of having a surgical site infection (those who think they have an infection) with rapid follow-up by a professional trained to diagnose infection according to agreed criteria is an effective method of identifying infection after discharge from hospital.
A prospective study was performed to develop
a clinical prediction rule that incorporated demographic and clinical factors
predictive of a fracture of the scaphoid. Of 260 consecutive patients
with a clinically suspected or radiologically confirmed scaphoid
fracture, 223 returned for evaluation two weeks after injury and
formed the basis of our analysis. Patients were evaluated within
72 hours of injury and at approximately two and six weeks after injury
using clinical assessment and standard radiographs. Demographic
data and the results of seven specific tests in the clinical examination
were recorded. There were 116 (52%) men and their mean age was 33 years (13
to 95; Our study has demonstrated that clinical prediction rules have
a considerable influence on the probability of a suspected scaphoid
fracture. This will help improve the use of supplementary investigations
where the diagnosis remains in doubt.
Clinical prediction algorithms are used to differentiate
transient synovitis from septic arthritis. These algorithms typically
include the erythrocyte sedimentation rate (ESR), although in clinical practice
measurement of the C-reactive protein (CRP) has largely replaced
the ESR. We evaluated the use of CRP in a predictive algorithm. The records of 311 children with an effusion of the hip, which
was confirmed on ultrasound, were reviewed (mean age 5.3 years (0.2
to 15.1)). Of these, 269 resolved without intervention and without
long-term sequelae and were considered to have had transient synovitis.
The remaining 42 underwent arthrotomy because of suspicion of septic
arthritis. Infection was confirmed in 29 (18 had micro-organisms
isolated and 11 had a high synovial fluid white cell count). In
the remaining 13 no evidence of infection was found and they were
also considered to have had transient synovitis. In total 29 hips
were categorised as septic arthritis and 282 as transient synovitis.
The temperature, weight-bearing status, peripheral white blood cell
count and CRP was reviewed in each patient. A CRP >
20 mg/l was the strongest independent risk factor for
septic arthritis (odds ratio 81.9, p <
0.001). A multivariable
prediction model revealed that only two determinants (weight-bearing
status and CRP >
20 mg/l) were independent in differentiating septic
arthritis from transient synovitis. Individuals with neither predictor
had a <
1% probability of septic arthritis, but those with both
had a 74% probability of septic arthritis. A two-variable algorithm
can therefore quantify the risk of septic arthritis, and is an excellent
negative predictor.
Blood metal ions have been widely used to investigate
metal-on-metal hip replacements, but their ability to discriminate
between well-functioning and failed hips is not known. The Medicines
and Healthcare products Regulatory Agency (MHRA) has suggested a
cut-off level of 7 parts per billion (ppb). We performed a pair-matched, case-control study to investigate
the sensitivity and specificity of blood metal ion levels for diagnosing
failure in 176 patients with a unilateral metal-on-metal hip replacement.
We recruited 88 cases with a pre-revision, unexplained failed hip
and an equal number of matching controls with a well-functioning
hip. We investigated the 7 ppb cut-off level for the maximum of
cobalt or chromium and determined optimal mathematical cut-off levels
from receiver-operating characteristic curves. The 7 ppb cut-off level for the maximum of cobalt or chromium
had a specificity of 89% and sensitivity 52% for detecting a pre-operative
unexplained failed metal on metal hip replacement. The optimal cut-off
level for the maximum of cobalt or chromium was 4.97 ppb and had
sensitivity 63% and specificity 86%. Blood metal ions had good discriminant ability to separate failed
from well-functioning hip replacements. The MHRA cut-off level of
7 ppb provides a specific test but has poor sensitivity.
A delay in the diagnosis of paediatric acute
and subacute haematogenous osteomyelitis can lead to potentially devastating
morbidity. There are no definitive guidelines for diagnosis, and
recommendations in the literature are generally based on expert
opinions, case series and cohort studies. All articles in the English literature on paediatric osteomyelitis
were searched using MEDLINE, CINAHL, EMBASE, Google Scholar, the
Cochrane Library and reference lists. A total of 1854 papers were
identified, 132 of which were examined in detail. All aspects of
osteomyelitis were investigated in order to formulate recommendations. On admission 40% of children are afebrile. The tibia and femur
are the most commonly affected long bones. Clinical examination,
blood and radiological tests are only reliable for diagnosis in
combination. Most studies were retrospective and there is a need for large,
multicentre, randomised, controlled trials to define protocols for
diagnosis and treatment. Meanwhile, evidence-based algorithms are
suggested for accurate and early diagnosis and effective treatment.
Two major complications of hip replacement are loosening and infection. Reliable differentiation between these pathological processes is difficult since both may be accompanied by similar symptoms. Our aim was to assess the diagnostic ability of triple-phase bone scanning (TPBS) and positron-emission tomography (PET) to detect and differentiate these complications in patients with a hip arthroplasty. Both TPBS and PET were performed in 63 patients (92 prostheses). The radiotracer for PET imaging was 18F-fluorodeoxyglucose (FDG). Image interpretation was performed according to qualitative and quantitative criteria although the final diagnosis was based upon either surgical findings or clinical follow-up. The sensitivity, specificity and accuracy of PET was 0.94, 0.95 and 0.95 respectively, compared with 0.68, 0.76 and 0.74 for TPBS. We found that an image interpretation based exclusively upon quantitative criteria was inappropriate because of its low selectivity. The histological examination indicated that increased periprosthetic uptake of FDG in patients with aseptic loosening was caused by wear-induced polyethylene particles and the subsequent growth of aggressive granulomatous tissue.
This conversation represents an attempt by several
arthroplasty surgeons to critique several abstracts presented over
the last year as well as to use them as a jumping off point for trying
to figure out where they fit in into our current understanding of
multiple issues in modern hip and knee arthroplasty.
We report the outcome of 161 of 257 surgically fixed acetabular fractures. The operations were undertaken between 1989 and 1998 and the patients were followed for a minimum of ten years. Anthropometric data, fracture pattern, time to surgery, associated injuries, surgical approach, complications and outcome were recorded. Modified Merle D’Aubigné score and Matta radiological scoring systems were used as outcome measures. We observed simple fractures in 108 patients (42%) and associated fractures in 149 (58%). The result was excellent in 75 patients (47%), good in 41 (25%), fair in 12 (7%) and poor in 33 (20%). Poor prognostic factors included increasing age, delay to surgery, quality of reduction and some fracture patterns. Complications were common in the medium- to long-term and functional outcome was variable. The gold-standard treatment for displaced acetabular fractures remains open reduction and internal fixation performed in dedicated units by specialist surgeons as soon as possible.
We investigated the role of ion release in the assessment of fixation of the implant after total knee replacement and hypothesised that ion monitoring could be a useful parameter in the diagnosis of prosthetic loosening. We enrolled 59 patients with unilateral procedures and measured their serum aluminium, titanium, chromium and cobalt ion levels, blinded to the clinical and radiological outcome which was considered to be the reference standard. The cut-off levels for detection of the ions were obtained by measuring the levels in 41 healthy blood donors who had no implants. Based on the clinical and radiological evaluation the patients were divided into two groups with either stable (n = 24) or loosened (n = 35) implants. A significant increase in the mean level of Cr ions was seen in the group with failed implants (p = 0.001). The diagnostic accuracy was 71% providing strong evidence of failure when the level of Cr ions exceeded the cut-off value. The possibility of distinguishing loosening from other causes of failure was demonstrated by the higher diagnostic accuracy of 83%, when considering only patients with failure attributable to loosening. Measurement of the serum level of Cr ions may be of value for detecting failure due to loosening when the diagnosis is in doubt. The other metal ions studies did not have any diagnostic value.
An MR scan was performed on all patients who presented to our hospital with a clinical diagnosis of a fracture of the proximal femur, but who had no abnormality on plain radiographs. This was a prospective study of 102 consecutive patients over a ten-year period. There were 98 patients who fulfilled our inclusion criteria, of whom 75 were scanned within 48 hours of admission, with an overall mean time between admission and scanning of 2.4 days (0 to 10). A total of 81 patients (83%) had abnormalities detected on MRI; 23 (23%) required operative management. The use of MRI led to the early diagnosis and treatment of occult hip pathology. We recommend that incomplete intertrochanteric fractures are managed non-operatively with protected weight-bearing. The study illustrates the high incidence of fractures which are not apparent on plain radiographs, and shows that MRI is useful when diagnosing other pathology such as malignancy, which may not be apparent on plain films.
Invasive group A streptococcus (iGAS) is the most common cause of monomicrobial necrotising fasciitis. Necrotising infections of the extremities may present directly to orthopaedic surgeons or by reference from another admitting specialty. Recent epidemiological data from the Health Protection Agency suggest an increasing incidence of iGAS infection in England. Almost 40% of those affected had no predisposing illnesses or risk factors, and the proportion of children presenting with infections has risen. These observations have prompted the Chief Medical Officer for the Central Alerting System in England to write to general practitioners and hospitals, highlighting the need for clinical vigilance, early diagnosis and rapid initiation of treatment in suspected cases. The purpose of this annotation is to summarise the recent epidemiological trends, describe the presenting features and outline the current investigations and treatment of this rare but life-threatening condition.
Non-accidental injury (NAI) in children includes orthopaedic trauma throughout the skeleton. Fractures with soft-tissue injuries constitute the majority of manifestations of physical abuse in children. Fracture and injury patterns vary with age and development, and NAI is intrinsically related to the mobility of the child. No fracture in isolation is pathognomonic of NAI, but specific abuse-related injuries include multiple fractures, particularly at various stages of healing, metaphyseal corner and bucket-handle fractures and fractures of ribs. Isolated or multiple rib fractures, irrespective of location, have the highest specificity for NAI. Other fractures with a high specificity for abuse include those of the scapula, lateral end of the clavicle, vertebrae and complex skull fractures. Injuries caused by NAI constitute a relatively small proportion of childhood fractures. They may be associated with significant physical and psychological morbidity, with wide- ranging effects from deviations in normal developmental progression to death. Orthopaedic surgeons must systematically assess, recognise and act on the indicators for NAI in conjunction with the paediatric multidisciplinary team.