Randomised controlled trials represent the gold standard in the evaluation of outcome of treatment. They are needed because differences between treatment effects have been minimised and observational studies may give a biased estimation of the outcome. However, conducting this kind of trial is challenging. Several methodological issues, including patient or surgeon preference, blinding, surgical standardisation, as well as external validity, have to be addressed in order to lower the risk of bias. Specific tools have been developed in order to take into account the specificity of evaluation of the literature on non-pharmacological intervention. A better knowledge of methodological issues will allow the orthopaedic surgeon to conduct more appropriate studies and to better appraise the limits of his intervention.

We report a retrospective review of the incidence of venous thromboembolism in 463 consecutive patients who underwent primary total hip arthroplasty (487 procedures). Treatment included both total hip replacement and hip resurfacing, and the patients were managed without anticoagulants. The thromboprophylaxis regimen included an antiplatelet agent, generally aspirin, hypotensive epidural anaesthesia, elastic compression stockings and early mobilisation. In 258 of these procedures (244 patients) performed in 2005 (cohort A) mechanical compression devices were not used, whereas in 229 (219 patients) performed during 2006 (cohort B) bilateral intermittent pneumatic calf compression was used.

All operations were performed through a posterior mini-incision approach. Patients who required anticoagulation for pre-existing medical problems and those undergoing revision arthroplasty were excluded. Doppler ultrasonographic screening for deep-vein thrombosis was performed in all patients between the fourth and sixth post-operative days. All patients were reviewed at a follow-up clinic six to ten weeks after the operation. In addition, reponse to a questionnaire was obtained at the end of 12 weeks post-operatively.

No symptomatic calf or above-knee deep-vein thrombosis or pulmonary embolism occurred. In 25 patients in cohort A (10.2%) and in ten patients in cohort B (4.6%) asymptomatic calf deep-vein thromboses were detected ultrasonographically. This difference was statistically significant (p = 0.03). The regimen followed by cohort B offers the prospect of a low incidence of venous thromboembolism without subjecting patients to the higher risk of bleeding associated with anticoagulant use.

In a randomised study, 28 patients with a mean age of 62.2 years (32 to 81) with osteoarthritis or avascular necrosis of the hip received either a ceramic-on-ceramic or a metal-on-metal total hip replacement. Apart from the liners the acetabular and femoral components were made of Ti-Al-Nb alloy. The serum aluminium and cobalt levels were measured before, and at one year after surgery.

The 15 patients in the ceramic-on-ceramic group had a median pre-operative aluminium level of 1.3 μg/l (0.25 to 8.4) and a cobalt level below the detection limit. At one year the aluminium level was 1.1 μg/l (0.25 to 2.3) and the cobalt level was 0.4 μg/l (0.15 to 0.7). The 13 patients in the metal-on-metal group had a median pre-operative aluminium level of 1.9 μg/l (0.25 to 4.4) and a cobalt level below the detection limit. At one year the median aluminium level was 0.9 μg/l (0.25 to 3.9) whereas the cobalt level was 1.4 μg/l (0.5 to 10.5). This increase in the cobalt level at one year was significant (p < 0.001).

Our findings indicate that ceramic-on-ceramic bearings do not cause elevated levels of serum aluminium in the first post-operative year.

Since the introduction of the first National Arthroplasty Register in Sweden in 1975, many other countries have tried to adopt the successful Scandinavian system. However, not all have overcome the political and practical difficulties of establishing a working register. We have surveyed the current registries to establish the key factors required for an effective database. We have received detailed information from 15 arthroplasty registers worldwide. The legal conditions under which they operate together with the methods of collection and handling of the data differ widely, but the fulfilment of certain criteria is necessary achieve a high degree of completeness of the data to ensure the provision of statistically relevant information.

Platelet-rich plasma is a new inductive therapy which is being increasingly used for the treatment of the complications of bone healing, such as infection and nonunion. The activator for platelet-rich plasma is a mixture of thrombin and calcium chloride which produces a platelet-rich gel.

We analysed the antibacterial effect of platelet-rich gel in vitro by using the platelet-rich plasma samples of 20 volunteers. In vitro laboratory susceptibility to platelet-rich gel was determined by the Kirby-Bauer disc-diffusion method. Baseline antimicrobial activity was assessed by measuring the zones of inhibition on agar plates coated with selected bacterial strains.

Zones of inhibition produced by platelet-rich gel ranged between 6 mm and 24 mm (mean 9.83 mm) in diameter. Platelet-rich gel inhibited the growth of Staphylococcus aureus and was also active against Escherichia coli. There was no activity against Klebsiella pneumoniae, Enterococcus faecalis, and Pseudomonas aeruginosa. Moreover, platelet-rich gel seemed to induce the in vitro growth of Ps. aeruginosa, suggesting that it may cause an exacerbation of infections with this organism. We believe that a combination of the inductive and antimicrobial properties of platelet-rich gel can improve the treatment of infected delayed healing and nonunion.

We undertook a study on eight arms from fresh cadavers to define the clinical usefulness of the lesser sigmoid notch as a landmark when reconstructing the length of the neck of the radius in replacement of the head with a prosthesis. The head was resected and its height measured, along with several control measurements. This was compared with in situ measurements from the stump of the neck to the proximal edge of the lesser sigmoid notch of the ulna. All the measurements were performed three times by three observers acting independently.

The results were highly reproducible with intra- and interclass correlations of > 0.99. The mean difference between the measurement on the excised head and the distance from the stump of the neck and the lesser sigmoid notch was −0.02 mm (−1.24 to +0.97). This difference was not statistically significant (p = 0.78).

The proximal edge of the lesser sigmoid notch provides a reliable landmark for positioning a replacement of the radial head and may have clinical application.

Little is known about the efficacy of graduated compression stockings in preventing venous thromboembolism after hip surgery. We conducted a prospective, randomised single-blind study to determine whether the addition of compression stockings to fondaparinux conferred any additional benefit.

The study included 874 patients, of whom 795 could be evaluated (400 in the fondaparinux group and 395 in the fondaparinux plus compression stocking group). Fondaparinux was given post-operatively for five to nine days, either alone or combined with wearing stockings, which were worn for a mean 42 days (35 to 49).

The study outcomes were venous thromboembolism, or sudden death before day 42. Duplex ultrasonography was scheduled within a week of day 42. Safety outcomes were bleeding and death from venous thromboembolism.

The prevalence of deep-vein thrombosis was similar in the two groups 5.5% (22 of 400) in the fondaparinux group and 4.8 (19 of 395) in the fondaparinux plus stocking group (odds ratio 0.88, 95% confidence interval 0.46 to 1.65, p = 0.69). Major bleeding occurred in only one patient.

The addition of graduated compression stockings to fondaparinux appears to offer no additional benefit over the use of fondaparinux alone.

We have evaluated the effect of the short-term administration of low therapeutic doses of modern COX-2 inhibitors on the healing of fractures.

A total of 40 adult male New Zealand rabbits were divided into five groups. A mid-diaphyseal osteotomy of the right ulna was performed and either normal saline, prednisolone, indometacin, meloxicam or rofecoxib was administered for five days. Radiological, biomechanical and histomorphometric evaluation was performed at six weeks.

In the group in which the highly selective anti-COX-2 agent, rofecoxib, was used the incidence of radiologically-incomplete union was similar to that in the control group. All the biomechanical parameters were statistically significantly lower in both the prednisolone and indometacin (p = 0.01) and in the meloxicam (p = 0.04) groups compared with the control group. Only the fracture load values were found to be statistically significantly lower (p = 0.05) in the rofecoxib group. Histomorphometric parameters were adversely affected in all groups with the specimens of the rofecoxib group showing the least negative effect.

Our findings indicated that the short-term administration of low therapeutic doses of a highly selective COX-2 inhibitor had a minor negative effect on bone healing.

We investigated several factors which affect the stability of cortical screws in osteoporotic bone using 18 femora from cadavers of women aged between 45 and 96 years (mean 76). We performed bone densitometry to measure the bone mineral density of the cortical and cancellous bone of the shaft and head of the femur, respectively. The thickness and overall bone mass of the cortical layer of the shaft of the femur were measured using a microCT scanner. The force required to pull-out a 3.5 mm titanium cortical bone screw was determined after standardised insertion into specimens of the cortex of the femoral shaft.

A significant correlation was found between the pull-out strength and the overall bone mass of the cortical layer (r² = 0.867, p < 0.01) and also between its thickness (r² = 0.826, p < 0.01) and bone mineral density (r² = 0.861, p < 0.01). There was no statistically significant correlation between the age of the donor and the pull-out force (p = 0.246), the cortical thickness (p = 0.199), the bone mineral density (p = 0.697) or the level of osteoporosis (p = 0.378).

We conclude that the overall bone mass, the thickness and the bone mineral density of the cortical layer, are the main factors which affect the stability of a screw in human female osteoporotic cortical bone.

There is no simple method available to identify patients who will develop recurrent instability after an arthroscopic Bankart procedure and who would be better served by an open operation.

We carried out a prospective case-control study of 131 consecutive unselected patients with recurrent anterior shoulder instability who underwent this procedure using suture anchors. At follow-up after a mean of 31.2 months (24 to 52) 19 (14.5%) had recurrent instability. The following risk factors were identified: patient age under 20 years at the time of surgery; involvement in competitive or contact sports or those involving forced overhead activity; shoulder hyperlaxity; a Hill-Sachs lesion present on an anteroposterior radiograph of the shoulder in external rotation and/or loss of the sclerotic inferior glenoid contour.

These factors were integrated in a 10-point pre-operative instability severity index score and tested retrospectively on the same population. Patients with a score over 6 points had an unacceptable recurrence risk of 70% (p < 0.001). On this basis we believe that an arthroscopic Bankart repair is contraindicated in these patients, to whom we now suggest a Bristow-Latarjet procedure instead.

We have compared the outcomes of the use of external fixation devices for spanning or sparing the ankle joint in the treatment of fractures of the tibial plafond, focusing on the complications and the rates of healing. We have devised a scoring system for the quality of reporting of clinical outcomes, to determine the reliability of the results.

We conducted a search of publications in English between 1990 and 2006 using the Pubmed search engine. The key words used were pilon, pylon, plafond fractures, external fixation. A total of 15 articles, which included 465 fractures, were eligible for final evaluation.

There were no statistically significant differences between spanning and sparing fixation systems regarding the rates of infection, nonunion, and the time to union. Patients treated with spanning frames had significantly greater incidence of malunion compared with patients treated with sparing frames. In both groups, the outcome reporting score was very low; 60% of reports involving infection, nonunion or malunion scored 0 points.

Polymethylmethacrylate remains one of the most enduring materials in orthopaedic surgery. It has a central role in the success of total joint replacement and is also used in newer techniques such as percutaneous vertebroplasty and kyphoplasty.

This article describes the current uses and limitations of polymethylmethacrylate in orthopaedic surgery. It focuses on its mechanical and chemical properties and links these to its clinical performance. The behaviour of antibiotic-loaded bone cement are discussed, together with areas of research that are now shedding light upon the behaviour of this unique biomaterial.

We used a knee-sparing distal femoral endoprosthesis in young patients with malignant bone tumours of the distal femur in whom it was possible to resect the tumour and to preserve the distal femoral condyles. The proximal shaft of the endoprosthesis had a coated hydroxyapatite collar, while the distal end had hydroxyapatite-coated extracortical plates to secure it to the small residual femoral condylar fragment. We reviewed the preliminary results of this endoprosthesis in eight patients with primary bone tumours of the distal femur. Their mean age at surgery was 17.years (14 to 21). The mean follow-up was 24 months (20 to 31). At final follow-up the mean flexion at the knee was 102° (20° to 120°) and the mean Musculoskeletal Tumour Society score was 80% (57% to 96.7%).

There was excellent osteointegration at the prosthesis-proximal bone interface with formation of new bone around the hydroxyapatite collar. The prosthesis allowed preservation of the knee and achieved a good functional result. Formation of new bone and remodelling at the interface make the implant more secure. Further follow-up is required to determine the long-term structural integrity of the prosthesis.

We carried out a prospective randomised study designed to compare the penetration rate of acetabular polyethylene inserts of identical design but different levels of cross-linking at a minimum of four years follow-up. A total of 102 patients (102 hips) were randomised to receive either highly cross-linked Durasul, or contemporary Sulene polyethylene inserts at total hip replacement. A single blinded observer used the Martell system to assess penetration of the femoral head. At a mean follow-up of 4.9 years (4.2 to 6.1) the mean femoral head penetration rate was 0.025 mm/year (sd 0.128) in the Durasul group compared with 0.106 mm/year (sd 0.109) in the Sulene group (Mann-Whitney test, p = 0.0027). The mean volumetric penetration rate was 29.24 mm³/year (sd 44.08) in the Durasul group compared with 53.32 mm³/year (sd 48.68) in the Sulene group. The yearly volumetric penetration rate was 55% lower in the Durasul group (Mann-Whitney test, p = 0.0058). Longer term results are needed to investigate whether less osteolysis will occur.

Dislocation remains a major concern after total hip replacement, and is often attributed to malposition of the components. The optimum position for placement of the components remains uncertain. We have attempted to identify a relatively safe zone in which movement of the hip will occur without impingement, even if one component is positioned incorrectly. A three-dimensional computer model was designed to simulate impingement and used to examine 125 combinations of positioning of the components in order to allow maximum movement without impingement. Increase in acetabular and/or femoral anteversion allowed greater internal rotation before impingement occurred, but decreases the amount of external rotation. A decrease in abduction of the acetabular components increased internal rotation while decreasing external rotation. Although some correction for malposition was allowable on the opposite side of the joint, extreme degrees could not be corrected because of bony impingement.

We introduce the concept of combined component position, in which anteversion and abduction of the acetabular component, along with femoral anteversion, are all defined as critical elements for stability.

We report the mid-term results of a new patellofemoral arthroplasty for established isolated patellofemoral arthritis. We have reviewed the experience of 109 consecutive patellofemoral resurfacing arthroplasties in 85 patients who were followed up for at least five years.

The five-year survival rate, with revision as the endpoint, was 95.8% (95% confidence interval 91.8% to 99.8%). There were no cases of loosening of the prosthesis. At five years the median Bristol pain score improved from 15 of 40 points (interquartile range 5 to 20) pre-operatively, to 35 (interquartile range 20 to 40), the median Melbourne score from 10 of 30 points (interquartile range 6 to 15) to 25 (interquartile range 20 to 29), and the median Oxford score from 18 of 48 points (interquartile range 13 to 24) to 39 (interquartile range 24 to 45). Successful results, judged on a Bristol pain score of at least 20 at five years, occurred in 80% (66) of knees. The main complication was radiological progression of arthritis, which occurred in 25 patients (28%) and emphasises the importance of the careful selection of patients. These results give increased confidence in the use of patellofemoral arthroplasty.

Talipes equinovarus is one of the more common congenital abnormalities affecting the lower limb and can be challenging to manage. This review provides a comprehensive update on idiopathic congenital talipes equinovarus with emphasis on the initial treatment. Current management is moving away from operative towards a more conservative treatment using the Ponseti regime. The long-term results of surgical correction and the recent results of conservative treatment will be discussed.

In a prospective study, 232 neonates were examined sonographically using the methods of Graf and Terjesen. In order to determine the reproducibility of the methods, 50 hips were evaluated by two skilled examiners. In an inter-observer study, five physicians and five medical students evaluated 24 images, which were evaluated on ten occasions at two-weekly intervals by one of the authors. Statistical evaluation used the Bland-Altman approach.

The neonates (110 females, 122 males) were less than four days old. The mean α angle was 62.4° and mean femoral head cover was 55.4%. According to Graf’s method, 1.3% of hips were pathological, compared with 4.1% according to Terjesen. Spearman’s correlation coefficient between femoral head cover and α angles was 0.552. The Bland-Altman approach shows greater variation for femoral head cover than for α, if measured by experienced examiners. The Bland-Altman approach shows almost equal reproducibility for α and femoral head cover in the inter-observer test, but better repeatability for α in the intra-observer test.

The Graf results relate better than Terjesen’s to the well-known frequency of 1% to 2% hip dysplasia in the European population. Kappa statistics indicate a fair agreement between the two methods. Inter-observer evaluation shows an equal reproducibility of both methods, whereas intra-observer tests reveal better repeatability with Graf’s method.

Because the femoral head/neck junction is preserved in hip resurfacing, patients may be at greater risk of impingement, leading to abnormal wear patterns and pain. We assessed femoral head/neck offset in 63 hips undergoing metal-on-metal hip resurfacing and in 56 hips presenting with non-arthritic pain secondary to femoroacetabular impingement. Most hips undergoing resurfacing (57%; 36) had an offset ratio ≤ 0.15 pre-operatively and required greater correction of offset at operation than the rest of the group. In the non-arthritic hips the mean offset ratio was 0.137 (0.04 to 0.23), with the offset ratio correlating negatively to an increasing α angle. An offset ratio ≤ 0.15 had a 9.5-fold increased relative risk of having an α angle ≥ 50.5°. Most hips undergoing resurfacing have an abnormal femoral head/neck offset, which is best assessed in the sagittal plane.