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 Journal of Bone and Joint Surgery.

We reviewed 27 diabetic patients who sustained a tibial fracture treated with a reamed intramedullary nail and compared them with a control group who did not have diabetes. There were 23 closed fractures and four were open. Union was delayed until after six months in 12 of the 23 (52%) diabetic patients with closed fractures and ten of the 23 (43%) control patients (p = 0.768). In two patients with diabetes (9%), closed tibial fractures failed to unite and required exchange nailing, whereas all closed fractures in the control group healed without further surgery (p = 0.489). In both the diabetic and control groups with closed fractures two patients (9%) developed superficial infections. There were two (9%) deep infections in diabetic patients with closed fractures, but none in the control group (p = 0.489).

Overall, there was no significant difference in the rate of complications between the diabetic patients and the control group, but there was a tendency for more severe infections in patients with diabetes.

The pathophysiology of intervertebral disc degeneration has been extensively studied. Various factors have been suggested as influencing its aetiology, including mechanical factors, such as compressive loading, shear stress and vibration, as well as ageing, genetic, systemic and toxic factors, which can lead to degeneration of the disc through biochemical reactions. How are these factors linked? What is their individual importance? There is no clear evidence indicating whether ageing in the presence of repetitive injury or repetitive injury in the absence of ageing plays a greater role in the degenerative process. Mechanical factors can trigger biochemical reactions which, in turn, may promote the normal biological changes of ageing, which can also be accelerated by genetic factors. Degradation of the molecular structure of the disc during ageing renders it more susceptible to superimposed mechanical injuries.

This review supports the theory that degeneration of the disc has a complex multifactorial aetiology. Which factors initiate the events in the degenerative cascade is a question that remains unanswered, but most evidence points to an age-related process influenced primarily by mechanical and genetic factors.

We have examined the relationship between the size of the flexion gap and the anterior translation of the tibia in flexion during implantation of a posterior cruciate ligament (PCL)-retaining BalanSys total knee replacement (TKR). In 91 knees, the flexion gap and anterior tibial translation were measured intra-operatively using a custom-made, flexible tensor-spacer device.

The results showed that for each increase of 1 mm in the flexion gap in the tensed knee a mean anterior tibial translation of 1.25 mm (SD 0.79, 95% confidence interval 1.13 to 1.37) was produced.

When implanting a PCL-retaining TKR the surgeon should be aware that the tibiofemoral contact point is related to the choice of thickness of the polyethylene insert. An additional thickness of polyethylene insert of 2 mm results in an approximate increase in tibial anterior translation of 2.5 mm while the flexed knee is distracted with a force of between 100 N and 200 N.

We compared the alignment of 39 total knee replacements implanted using the conventional alignment guide system with 37 implanted using a CT-based navigation system, performed by a single surgeon. The knees were evaluated using full-length weight-bearing anteroposterior radiographs, lateral radiographs and CT scans.

The mean hip-knee-ankle angle, coronal femoral component angle and coronal tibial component angle were 181.8° (174.2° to 188.3°), 88.5° (84.0° to 91.8°) and 89.7° (86.3° to 95.1°), respectively for the conventional group and 180.8° (178.2° to 185.1°), 89.3° (85.8° to 92.0°) and 89.9° (88.0° to 93.0°), respectively for the navigated group.

The mean sagittal femoral component angle was 85.5° (80.6° to 92.8°) for the conventional group and 89.6° (85.5° to 94.0°) for the navigated group.

The mean rotational femoral and tibial component angles were −0.7° (−8.8° to 9.8°) and −3.3° (−16.8° to 5.8°) for the conventional group and −0.6° (−3.5° to 3.0°) and 0.3° (−5.3° to 7.7°) for the navigated group.

The ideal angles of all alignments in the navigated group were obtained at significantly higher rates than in the conventional group. Our results demonstrated significant improvements in component positioning with a CT-based navigation system, especially with respect to rotational alignment.

Our aim was to assess the intra- and inter-observer reliability in the establishment of the anterior pelvic plane used in imageless computer-assisted navigation. From this we determined the subsequent effects on version and inclination of the acetabular component.

A cadaver model was developed with a specifically-designed rod which held the component tracker at a fixed orientation to the pelvis, leaving the anterior pelvic plane as the only variable. Eight surgeons determined the anterior pelvic plane by palpating and registering the bony landmarks as reference points. The exact anterior pelvic plane was then established by using anatomically-placed bone screws as reference points.

The difference between the surgeons was found to be highly significant (p < 0.001). The variation was significantly larger for anteversion (sd 9.6°) than for inclination (sd 6.3°). The present method for registering pelvic landmarks shows significant inaccuracy, which highlights the need for improved methods of registration before this technique is considered to be safe.

Magnification of anteroposterior radiographs of the pelvis is variable. To improve the accuracy of templating, reliable and radiographer-friendly methods of scaling are necessary. We assessed two methods of scaling digital radiographs of the pelvis: placing a coin of known diameter in the plane of interest between the patient’s thighs, and using a caliper to measure the bony width of the pelvis. A total of 39 patients who had recently undergone hemiarthroplasty of the hip or total hip replacement were enrolled in the study. The accuracy of the methods was assessed by comparing the actual diameter of the head of the prosthesis with the measured on-screen value. The coin method was within a mean of 1.12% (0% to 2.38%) of the actual measurement, the caliper group within 6.99% (0% to 16.67%). The coin method was significantly more accurate (p < 0.001). It was also reliable and radiographer friendly. We recommend it as the method of choice for scaling radiographs of the pelvis before hip surgery.

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 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.

Between 2000 and 2006 we performed salvage tibiotalar arthrodesis in 17 diabetic patients (17 ankles) with grossly unstable ankles caused by bimalleolar fractures complicated by Charcot neuro-arthropathy. There were ten women and seven men with a mean age of 61.6 years (57 to 69). A crossed-screw technique was used. Two screws were used in eight patients and three screws in nine. Additional graft from the malleoli was used in all patients. The mean follow-up was 26 months (12 to 48) and the mean time to union was 5.8 months (4 to 8). A stable ankle was achieved in 14 patients (82.4%), nine of whom had bony fusion and five had a stiff fibrous union. The results were significantly better in underweight patients, in those in whom surgery had been performed three to six months after the onset of acute Charcot arthropathy, in those who had received anti-resorptive medication during the acute stage, in those without extensive peripheral neuropathy, and in those with adequate peripheral oxygen saturation (> 95%). The arthrodesis failed because of avascular necrosis of the talus in only three patients (17.6%), who developed grossly unstable, ulcerated hindfeet, and required below-knee amputation.

We carried out a study to determine the effect of facet tropism on the development of adolescent and adult herniation of the lumbar disc. We assessed 149 levels in 140 adolescents aged between 13 and 18 years and 119 levels in 111 adults aged between 40 and 49 years with herniation. The facet tropism of each patient was measured at the level of the herniated disc by CT.

There was no significant difference in facet tropism between the herniated and the normal discs in both the adolescent and adult groups, except at the L4-L5 level in the adults. Facet tropism did not influence the development of herniation of the lumbar disc in either adolescents or adults.

Several aspects of the management of an orthopaedic surgical patient are not directly related to the surgical technique but are nevertheless essential for a successful outcome. Blood management is one of these. This paper considers the various strategies available for the management of blood loss in patients undergoing orthopaedic and trauma surgery.

This prospective five-year study analyses the impact of methicillin-resistant Staphylococcus aureus (MRSA) on an Irish orthopaedic unit. We identified 318 cases of MRSA, representing 0.76% of all admissions (41 971). A total of 240 (76%) cases were colonised with MRSA, while 120 (37.7%) were infected. Patients were admitted from home (218; 68.6%), nursing homes (72; 22.6%) and other hospitals (28; 8.8%). A total of 115 cases (36.6%) were colonised or infected on admission. Many patients were both colonised and infected at some stage. The length of hospital stay was almost trebled because of the presence of MRSA infection.

Encouragingly, overall infection rates have not risen significantly over the five years of the study despite increased prevalence of MRSA. However, the financial burden of MRSA is increasing, highlighting the need for progress in understanding how to control this resistant pathogen more effectively.

This study describes 146 primary total knee replacements, either fully or partially coated with hydroxyapatite of which 74 knees in 68 patients were available for clinical and radiological assessment at a mean of 11.2 years (10 to 15). The global failure rate was 1.37% and survival rate with mechanical failure as the end-point was 98.14%. Radiological assessment indicated intimate contact between bone and the hydroxyapatite coating. Over time the hydroxyapatite coating appears to encourage filling of interface gaps remaining after surgery. Our results compare favourably with those of series describing cemented or porous-coated knee replacements, and suggest that fixation with hydroxyapatite is a reliable option in primary total knee replacement.

Femoroacetabular cam impingement is thought to be a cause of premature osteoarthritis of the hip.

The presence of cam malformation was determined in 2803 standardised anteroposterior (AP) pelvic radiographs from the Copenhagen Osteoarthritis Study by measuring the alpha (α) angle and the triangular index, a new measure of asphericity of the femoral head. In addition, the α-angle and the triangular index were assessed on the AP and lateral hip radiographs of 82 men and 82 women randomly selected from patients scheduled for total hip replacement (THR). The influence of varying femoral rotation on the α angle and the triangular index was also determined in femoral specimens under experimental conditions.

From the 2803 radiographs the mean AP α-angle was 55° (30° to 100°) in men and 45° (34° to 108°) in women. Approximately 6% of men and 2% of women had cam malformation. The α-angle and triangular index were highly inter-related. Of those patients scheduled for THR, 36 men (44%) and 28 women (35%) had cam malformation identifiable on the AP radiographs. The triangular index proved to be more reliable in detecting cam malformation when the hip was held in varying degrees of rotation.

The combination of the α-angle and the triangular index will allow examination of historical radiographs for epidemiological purposes in following the natural history of the cam deformity.

Difficulties posed in managing developmental dysplasia of the hip diagnosed late include a high-placed femoral head, contracted soft tissues and a dysplastic acetabulum. A combination of open reduction with femoral shortening of untreated congenital dislocations is a well-established practice. Femoral shortening prevents excessive pressure on the located femoral head which can cause avascular necrosis. Instability due to a coexisting dysplastic shallow acetabulum is common, and so a pelvic osteotomy is performed to achieve a stable and concentric hip reduction. We retrospectively reviewed 15 patients (18 hips) presenting with developmental dysplasia of the hip aged four years and above who were treated by a one-stage combined procedure performed by the senior author. The mean age at operation was five years and nine months (4 years to 11 years). The mean follow-up was six years ten months (2 years and 8 months to 8 years and 8 months). All patients were followed up clinically and radiologically in accordance with McKay’s criteria and the modified Severin classification. According to the McKay criteria, 12 hips were rated excellent and six were good. All but one had a full range of movement. Eight had a limb-length discrepancy of about 1 cm. All were Trendelenburg negative. The modified Severin classification demonstrated four hips of grade IA, six of grade IB, and eight of grade II. One patient had avascular necrosis and one an early subluxation requiring revision.

One-stage correction of congenital dislocation of the hip in an older child is a safe and effective treatment with good results in the short to medium term.

Our aim in this prospective study was to compare the bone mineral density (BMD) around cementless acetabular and femoral components which were identical in geometry and had the same alumina modular femoral head, but differed in regard to the material of the acetabular liners (alumina ceramic or polyethylene) in 50 patients (100 hips) who had undergone bilateral simultaneous primary total hip replacement. Dual energy X-ray absorptiometry scans of the pelvis and proximal femur were obtained at one week, at one year, and annually thereafter during the five-year period of the study.

At the final follow-up, the mean BMD had increased significantly in each group in acetabular zone I of DeLee and Charnley (20% (15% to 26%), p = 0.003), but had decreased in acetabular zone II (24% (18% to 36%) in the alumina group and 25% (17% to 31%) in the polyethylene group, p = 0.001). There was an increase in the mean BMD in zone III of 2% (0.8% to 3.2%) in the alumina group and 1% (0.6% to 2.2%) in the polyethylene group (p = 0.315). There was a decrease in the mean BMD in the calcar region (femoral zone 7) of 15% (8% to 24%) in the alumina group and 14% (6% to 23%) in the polyethylene group (p < 0.001). The mean bone loss in femoral zone 1 of Gruen et al was 2% (1.1% to 3.1%) in the alumina group and 3% (1.3% to 4.3%) in the polyethylene group (p = 0.03), and in femoral zone 6, the mean bone loss was 15% (9% to 27%) in the alumina group and 14% (11% to 29%) in the polyethylene group compared with baseline values. There was an increase in the mean BMD on the final scans in femoral zones 2 (p = 0.04), 3 (p = 0.04), 4 (p = 0.12) and 5 (p = 0.049) in both groups.

There was thus no significant difference in the bone remodelling of the acetabulum and femur five years after total hip replacement in those two groups where the only difference was in the acetabular liner.

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 vs 0.96). Combining C-reactive protein and interleukin-6 identifies all patients with deep infection of the implant. Procalcitonin (> 0.3 ng/ml) and TNF-α (> 40 ng/ml) are very specific (0.98 vs 0.94) but have a low sensitivity (0.33 vs 0.43).

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.

We report our early experience with the use of a non-invasive distal femoral expandable endoprosthesis in seven skeletally immature patients with osteosarcoma of the distal femur. The patients had a mean age of 12.1 years (9 to 15) at the time of surgery. The prosthesis was lengthened at appropriate intervals in outpatient clinics, without anaesthesia, using the principle of electromagnetic induction. The patients were functionally evaluated using the Musculoskeletal Tumour Society scoring system. The mean follow-up was 20.2 months (14 to 30). The prostheses were lengthened by a mean of 25 mm (4.25 to 55) and maintained a mean knee flexion of 110° (100° to 120°). The mean Musculoskeletal Tumour Society score was 68% (11 to 29). Complications developed in two patients; one developed a flexion deformity of 25° at the knee joint, which was subsequently overcome and one died of disseminated disease. The early results from patients treated with this device have been encouraging. The implant avoids multiple surgical procedures, general anaesthesia and assists in maintaining leg-length equality.

The clinical results of bilateral total knee replacement staged at a one-week interval during a single hospital admission were compared with bilateral total knee replacements performed under the same anaesthetic and with bilateral total knee replacements performed during two separate admissions. The data were retrospectively reviewed. All operations had been performed by the same surgeon using the same design of prosthesis at a single institution.

The operative time and length of stay for the one-week staged group were comparable with those of the separate admission group but longer than for the patients treated under one anaesthetic. There was a low rate of complications and good clinical outcome in all groups at a mean follow-up of four years (1 to 7.2). The group staged at a one-week interval had the least blood loss (p = 0.004).

With appropriate patient selection, bilateral total knee replacement performed under a single anaesthetic, or staged at a one-week interval, is a safe and effective method to treat bilateral arthritis of the knee.