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.

There are unacceptable delays in the management of pelvic trauma in the United Kingdom. In 2003 this became a political issue after TV and radio coverage. Changes to the service were introduced, including trauma coordinators and a special tariff, but has it made a difference?

We carried out a retrospective case-control study in 80 patients who underwent a revision total hip replacement. Group A (40 patients) received tranexamic acid and intra-operative cell salvage. Group B (40 patients) was a matched control group and did not receive this management. Each group was divided into four subgroups: revision of both components, revision of both components with bone grafting, revision of the acetabular component with or without bone graft, and revision of the femoral component with or without bone graft.

In group A the total number of units transfused was 52, compared with 139 in group B, representing a reduction in blood usage of 62.5%. The mean amount of blood transfused from cell salvage in each group was 858 ml (113 to 2100), 477 ml (0 to 2680), 228 ml (75 to 315) and 464 ml (120 to 1125), respectively. There was a significant difference in the amount of blood returned between the groups (p < 0.0001).

In group A, 22 patients needed transfusion and in group B, 37 (p < 0.0001). A cost analysis calculation showed a total revenue saving of £70 000 and a potential saving throughout our facility of £318 288 per year.

Our results show that a significant reduction in blood transfusion can be made using combined cell salvage and tranexamic acid in revision surgery of the hip.

We performed a randomised, radiostereometric study comparing two different bone cements, one of which has been sparsely clinically documented. Randomisation of 60 total hip replacements (57 patients) into two groups of 30 was undertaken. All the patients were operated on using a cemented Charnley total hip replacement, the only difference between groups being the bone cement used to secure the femoral component. The two cements used were Palamed G and Palacos R with gentamicin. The patients were followed up with repeated clinical and radiostereometric examinations for two years to assess the micromovement of the femoral component and the clinical outcome.

The mean subsidence was 0.18 mm and 0.21 mm, and the mean internal rotation was 1.7° and 2.0° at two years for the Palamed G and Palacos R with gentamicin bone cements, respectively. We found no statistically significant differences between the groups. Micromovement occurred between the femoral component and the cement, while the cement mantle was stable inside the bone. The Harris hip score improved from a mean of 38 points (14 to 54) and 36 (10 to 57) pre-operatively to a mean of 92 (77 to 100) and 91 (63 to 100) at two years in the Palamed G and Palacos R groups, respectively. No differences were found between the groups.

Both bone cements provided good initial fixation of the femoral component and good clinical results at two years.

Iontophoresis is a novel technique which may be used to facilitate the movement of antibiotics into the substance of bone using an electrical potential applied externally. We have examined the rate of early infection in allografts following application of this technique in clinical practice. A total of 31 patients undergoing revision arthroplasty or surgery for limb salvage received 34 iontophoresed sequential allografts, of which 26 survived for a minimum of two years. The mean serum antibiotic levels after operation were low (gentamicin 0.37 mg/l (0.2 to 0.5); flucloxacillin 1 mg/l (0 to 1) and the levels in the drains were high (gentamicin 40 mg/l (2.5 to 131); flucloxacillin 17 mg/l (1 to 43). There were no early deep infections. Two late infections were presumed to be haemotogenous; 28 of the 34 allografts were retained. In 12 patients with pre-existing proven infection further infection has not occurred at a mean follow-up of 51 months (24 to 82).

We carried out a prospective study of 118 hydroxyapatite-coated, cementless total knee replacements in patients who were ≤ 55 years of age and who had primary (92; 78%) or post-traumatic (26; 22%) osteoarthritis. The mean period of follow-up was 7.9 years (5 to 12.5). The Knee Society clinical scores improved from a pre-operative mean of 98 (0 to 137) to a mean of 185 (135 to 200) at five years, and 173 (137 to 200) at ten years. There were two revisions of the tibial component because of aseptic loosening, and one case of polyethylene wear requiring further surgery. There was no osteolysis or progressive radiological loosening of any other component. At 12 years, the overall rate of implant survival was 97.5% (excluding exchange of spacer) and 92.1% (including exchange of spacer).

Cementless total knee replacement can achieve excellent long-term results in young, active patients with osteoarthritis. In contrast to total hip replacement, polyethylene wear, osteolysis and loosening of the prosthesis were not major problems for these patients, although it is possible that this observation could change with longer periods of follow-up.

There have been several reports of good survivorship and excellent function at ten years with fixed-bearing unicompartmental knee replacement. However, little is known about survival beyond ten years.

From the Bristol database of over 4000 knee replacements, we identified 203 St Georg Sled unicompartmental knee replacements (174 patients) which had already survived ten years. The mean age of the patients at surgery was 67.1 years (35.7 to 85) with 67 (38.5%) being under 65 years at the time of surgery. They were reviewed at a mean of 14.8 years (10 to 29.4) from surgery to determine survivorship and function. There were 99 knees followed up for 15 years, 21 for 20 years and four for 25 years. The remainder failed, were withdrawn, or the patient had died.

In 58 patients (69 knees) the implant was in situ at the time of death. Revision was undertaken in 16 knees (7.9%) at a mean of 13 years (10.2 to 21.6) after operation. In seven knees (3.4%) this was for progression of arthritis, in three (1.5%) for wear of polyethylene, in four (2%) for tibial loosening, in two (1%) for fracture of the femoral component and in two (1%) for infection. Two knees (1%) were revised for more than one reason.

The mean Bristol knee score of the surviving knees fell from 86 (34 to 100) to 79 (42 to 100) during the second decade. Survivorship to 20 years was 85.9% (95% CI 82.9% to 88.9%) and at 25 years was 80% (95% CI 70.2% to 89.8%). Satisfactory survival of a fixed-bearing unicompartmental knee replacement can be achieved into the second decade and beyond.

We report a retrospective analysis of the results of combined arthroscopically-assisted posterior cruciate ligament reconstruction and open reconstruction of the posterolateral corner in 19 patients with chronic (three or more months) symptomatic instability and pain in the knee.

All the operations were performed between 1996 and 2003 and all the patients were assessed pre- and post-operatively by physical examination and by applying three different ligament rating scores. All also had weight-bearing radiographs, MR scans and an examination under anaesthesia and arthroscopy pre-operatively. The posterior cruciate ligament reconstruction was performed using an arthroscopically-assisted single anterolateral bundle technique and the posterolateral corner structures were reconstructed using an open Larson type of tenodesis.

The mean follow up was 66.8 months (24 to 110). Pre-operatively, all the patients had a grade III posterior sag according to Clancy and demonstrated more than 20° of external rotation compared with the opposite normal knee on the Dial test. Post-operatively, seven patients (37%) had no residual posterior sag, 11 (58%) had a grade I posterior sag and one (5%) had a grade II posterior sag. In five patients (26%) there was persistent minimal posterolateral laxity. The Lysholm score improved from a mean of 41.2 (28 to 53) to 76.5 (57 to 100) (p = 0.0001) and the Tegner score from a mean of 2.6 (1 to 4) to 6.4 (4 to 9) (p = 0.0001).

We conclude that while a combined reconstruction of chronic posterior cruciate ligament and posterolateral corner instability improves the function of the knee, it does not restore complete stability.

We performed a double-blind, randomised controlled trial to assess the effectiveness of a continuous-infusion brachial plexus block with levobupivacaine compared with that of a standard single injection for the management of post-operative pain after surgery on the shoulder.

Eight patients were randomised to receive a pre-operative brachial plexus block using 30 ml of levobupivacaine 0.5% with adrenaline 1:200 000 followed by insertion of a 20-gauge polyamide catheter. This was connected to a disposable elastometric pump, set immediately after surgery to administer a continuous flow of levobupivacaine 0.25% at a rate of 5 ml per hour. The other eight patients were randomised to receive only the initial injection of 30 ml. The study was double-blinded with the aid of sham catheters and clamped pumps.

All patients were given regular paracetamol and were prescribed morphine through a patient-controlled analgesia pump. Motor and sensory block assessments, visual analogue scale pain scores and consumption of morphine were recorded after the operation and then at 6, 12 and 24 hours after administration of the block.

Satisfactory motor and sensory block was achieved in all patients. The mean visual analogue scale pain score at 12 hours and consumption of morphine at 24 hours after injection were significantly lower (p < 0.05) in the continuous-infusion group. This group also took longer to request their first additional analgesia and reported a significantly higher overall level of satisfaction.

Our study has shown that continuous interscalene infusion of levobupivacaine is an effective method of post-operative analgesia after major surgery of the shoulder.

Surgical access to the head of the radius is usually performed through a lateral approach. We present an alternative technique through a modified posterior approach which was developed following dissections of 22 human cadavers. An osteotomy of the supinator tuberosity was performed and reflected as a single unit with the attached annular ligament. Excellent exposure of the head of the radius was achieved, replacement of the head was undertaken and the osteotomy site repaired. The elbows were stable and had a full range of movement. The approach was then carried out on 13 patients for elective replacement of the head and was found to be safe and reproducible. In the patient group all osteotomies united, the elbows were stable and had an improved range of supination and pronation. There was no change in flexion and extension of the elbow. Complications included a haematoma and a reflex sympathetic dystrophy.

The modified posterior approach provides excellent access to the head and neck of the radius, gives good stability of the elbow and allows early mobilisation of the joint.

Bertolotti’s syndrome is characterised by anomalous enlargement of the transverse process(es) of the most caudal lumbar vertebra which may articulate or fuse with the sacrum or ilium and cause isolated L4/5 disc disease.

We analysed the elective MR scans of the lumbosacral spine of 769 consecutive patients with low back pain taken between July 2003 and November 2004. Of these 568 showed disc degeneration. Bertolotti’s syndrome was present in 35 patients with a mean age of 32.7 years (15 to 60). This was a younger age than that of patients with multiple disc degeneration, single-level disease and isolated disc degeneration at the L4/5 level (p ≤ 0.05). The overall incidence of Bertolotti’s syndrome in our study was 4.6% (35 of 769). It was present in 11.4% (20 patients) of the under-30 age group.

Our findings suggest that Bertolotti’s syndrome must form part of a list of differential diagnoses in the investigation of low back pain in young people.

We studied 70 consecutive patients with adolescent idiopathic scoliosis who underwent corrective surgery. They were divided into two groups. In the study group of 38 patients one or more modern blood-conservation measures was used peri-operatively. The 32 patients in the control group did not have these measures. Both groups were similar in regard to age, body-weight, the number of levels fused and the type of surgery.

Only two patients in the study group were transfused with homologous blood and these transfusions were ‘off-protocol’. Wastage of autologous pre-donated units was minimal (6 of 83 units). By contrast, all patients in the control group were transfused with homologous blood. In the study group there was a significant decrease (p = 0.005) in the estimated blood loss when all the blood-conservation methods were used.

The use of blood-conservation measures, the lowering of the haemoglobin trigger for transfusion and the education of the entire team involved in the care of the patient can prevent the need for homologous blood transfusion in patients undergoing surgery for adolescent idiopathic scoliosis.

We carried out an MRI study of the lumbar spine in 15 patients with achondroplasia to evaluate the degree of stenosis of the canal. They were divided into asymptomatic and symptomatic groups. We measured the sagittal canal diameter, the sagittal cord diameter, the interpedicular distance at the mid-pedicle level and the cross-sectional area of the canal and spinal cord at mid-body and mid-disc levels.

The MRI findings showed that in achondroplasia there was a significant difference between the groups in the cross-sectional area of the body canal at the upper lumbar levels. Patients with a narrower canal are more likely to develop symptoms of spinal stenosis than others.

This is a retrospective case review of 237 patients with displaced fractures of the acetabulum presenting over a ten-year period, with a minimum follow-up of two years, who were studied to test the hypothesis that the time to surgery was predictive of radiological and functional outcome and varied with the pattern of fracture. Patients were divided into two groups based on the fracture pattern: elementary or associated. The time to surgery was analysed as both a continuous and a categorical variable. The primary outcome measures were the quality of reduction and functional outcome. Logistic regression analysis was used to test our hypothesis, while controlling for potential confounding variables.

For elementary fractures, an increase in the time to surgery of one day reduced the odds of an excellent/good functional result by 15% (p = 0.001) and of an anatomical reduction by 18% (p = 0.0001). For associated fractures, the odds of obtaining an excellent/good result were reduced by 19% (p = 0.0001) and an anatomical reduction by 18% (p = 0.0001) per day.

When time was measured as a categorical variable, an anatomical reduction was more likely if surgery was performed within 15 days (elementary) and five days (associated). An excellent/good functional outcome was more likely when surgery was performed within 15 days (elementary) and ten days (associated).

The time to surgery is a significant predictor of radiological and functional outcome for both elementary and associated displaced fractures of the acetabulum. The organisation of regional trauma services must be capable of satisfying these time-dependent requirements to achieve optimal patient outcomes.

Our aim was to assess the reproducibility and the reliability of the Weber classification system for fractures of the ankle based on anteroposterior and lateral radiographs. Five observers with varying clinical experience reviewed 50 sets of blinded radiographs. The same observers reviewed the same radiographs again after an interval of four weeks. Inter- and intra-observer agreement was assessed based on the proportion of agreement and the values of the kappa coefficient.

For inter-observer agreement, the mean kappa value was 0.61 (0.59 to 0.63) and the proportion of agreement was 78% (76% to 79%) and for intra-observer agreement the mean kappa value was 0.74 (0.39 to 0.86) with an 85% (60% to 93%) observed agreement. These results show that the Weber classification of fractures of the ankle based on two radiological views has substantial inter-observer reliability and intra-observer reproducibility.

The most appropriate protocol for the biopsy of musculoskeletal tumours is controversial, with some authors advocating CT-guided core biopsy. At our hospital the initial biopsies of most musculoskeletal tumours has been by operative core biopsy with evaluation by frozen section which determines whether diagnostic tissue has been obtained and, if possible, gives the definitive diagnosis. In order to determine the accuracy and cost-effectiveness of this protocol we have undertaken a retrospective audit of biopsies of musculoskeletal tumours performed over a period of two years.

A total of 104 patients had biopsies according to this regime. All gave the diagnosis apart from one minor error which did not alter the management of the patient. There was no requirement for re-biopsy. This protocol was more labour-intensive and 38% more costly than CT-guided core biopsy (AU$1804 vs AU$1308). However, the accuracy and avoidance of the anxiety associated with repeat biopsy outweighed these disadvantages.

Aneurysmal bone cyst is a rare tumour-like lesion which develops during growth. Our aim was to determine the efficacy of the administration of percutaneous intralesional 3% polidocanol (hydroxypolyaethoxydodecan) as sclerotherapy.

Between July 1997 and December 2004 we treated 72 patients (46 males, 26 females) with a histologically-proven diagnosis of aneurysmal bone cyst, at various skeletal sites using this method. The sclerotherapy was performed under fluoroscopic guidance and general anaesthesia or sedation and local anaesthesia. The mean follow-up period was 34 months (26.5 to 80). The patients were evaluated using the Enneking system for functional assessment and all the lesions were radiologically quantified into four grades.

The mean age of patients was 15.6 years (3 to 38) and the mean number of injections was three (1 to 5). Ten patients were cured by a single injection. The mean reduction in size of the lesion (radiological healing) was found to be 76.6% (61.9% to 93.2%) with a mean clinical response of 84.5% (73.4% to 100%). Recurrence was seen in two patients (2.8%) within two years of treatment and both were treated successfully by further sclerotherapy.

Percutaneous sclerotherapy with polidocanol is a safe alternative to conventional surgery for the treatment of an aneurysmal bone cyst. It can be used at surgically-inaccessible sites and treatment can be performed on an out-patient basis.

A nationwide study of Perthes’ disease in Norway was undertaken over a five-year period from January 1996. There were 425 patients registered, which represents a mean annual incidence of 9.2 per 100 000 in subjects under 15 years of age, and an occurrence rate of 1:714 for the country as a whole. There were marked regional variations. The lowest incidence was found in the northern region (5.4 per 100 000 per year) and the highest in the central and western regions (10.8 and 11.3 per 100 000 per year, respectively). There was a trend towards a higher incidence in urban (9.5 per 100 000 per year) compared with rural areas (8.9 per 100 000 per year). The mean age at onset was 5.8 years (1.3 to 15.2) and the male:female ratio was 3.3:1.

We compared 402 patients with a matched control group of non-affected children (n = 1 025 952) from the Norwegian Medical Birth Registry and analysed maternal data (age at delivery, parity, duration of pregnancy), birth length and weight, birth presentation, head circumference, ponderal index and the presence of congenital anomalies. Children with Perthes’ disease were significantly shorter at birth and had an increased frequency of congenital anomalies.

Applying Sartwell’s log-normal model of incubation periods to the distribution of age at onset of Perthes’ disease showed a good fit to the log-normal curve. Our findings point toward a single cause, either genetic or environmental, acting prenatally in the aetiology of Perthes’ disease.

The practice of regular radiological follow-up of infants with a positive family history of developmental dysplasia of the hip is based on the widespread belief that primary acetabular dysplasia is a genetic disorder which can occur in the absence of frank subluxation or dislocation. We reviewed all infants who were involved in our screening programme for developmental dysplasia of the hip, between November 2002 and January 2004, and who had a normal clinical and ultrasound examination of the hip at six to eight weeks of age, but who, because of a family history of developmental dysplasia of the hip, had undergone further radiography after an interval of 6 to 12 months. The radiographs of 89 infants were analysed for signs of late dysplasia of the hip and assessed independently by three observers to allow for variability of measurement. There were 11 infants (11%) lost to follow-up.

All the patients had normal radiographs at the final follow-up and none required any intervention. We therefore question the need for routine radiological follow-up of infants with a positive family history of developmental dysplasia of the hip, but who are normal on clinical examination and assessment by ultrasound screening when six to eight weeks old.

Glenoid replacement is technically challenging. Removal of a cemented glenoid component often results in a large osseous defect which makes the immediate introduction of a revision prosthesis almost impossible. We describe a two-stage revision procedure using a reversed shoulder prosthesis. Freeze-dried allograft with platelet-derived growth factor was used to fill the glenoid defect. Radiological incorporation of the allograft was seen and its consistency allowed the placement of a screwed glenoid component. There were no signs of new mature bone formation on histological examination.

The addition of platelet-derived growth factor to the allograft seems to contribute to an increase in incorporation and hardness, but does not promote the growth of new bone.

A chordoma which occurs as a primary tumour outside the axial skeleton is known as an extra-axial chordoma, parachordoma or chordoma periphericum. It is extremely rare and therefore survival, recurrence and the rates of metastasis are not known. Whilst few recurrences have been described, the extra-axial chordoma has the potential for late recurrence at up to 12 years. Metastases are even less frequent.

We report the case of a 56-year-old woman who developed an extra-axial chordoma of the right thoracic wall in close relationship with the tenth rib. The tumour was completely removed and the prognosis is excellent.

Bone marrow mesenchymal stromal cells were aspirated from immature male green fluorescent protein transgenic rats and cultured in a monolayer. Four weeks after the creation of the osteochondral defect, the rats were divided into three groups of 18: the control group, treated with an intra-articular injection of phosphate-buffered saline only; the drilling group, treated with an intra-articular injection of phosphate-buffered saline with a bone marrow-stimulating procedure; and the bone marrow mesenchymal stromal cells group, treated with an intra-articular injection of bone marrow mesenchymal stromal cells plus a bone marrow-stimulating procedure. The rats were then killed at 4, 8 and 12 weeks after treatment and examined.

The histological scores were significantly better in the bone marrow mesenchymal stromal cells group than in the control and drilling groups at all time points (p < 0.05). The fluorescence of the green fluorescent protein-positive cells could be observed in specimens four weeks after treatment.

We examined the mechanical properties of Vicryl (polyglactin 910) mesh in vitro and assessed its use in vivo as a novel biomaterial to attach tendon to a hydroxyapatite-coated metal implant, the interface of which was augmented with autogenous bone and marrow graft. This was compared with tendon re-attachment using a compressive clamp device in an identical animal model. Two- and four-ply sleeves of Vicryl mesh tested to failure under tension reached 5.13% and 28.35% of the normal ovine patellar tendon, respectively. Four-ply sleeves supported gait in an ovine model with 67.05% weight-bearing through the operated limb at 12 weeks, without evidence of mechanical failure.

Mesh fibres were visible at six weeks but had been completely resorbed by 12 weeks, with no evidence of chronic inflammation. The tendon-implant neoenthesis was predominantly an indirect type, with tendon attached to the bone-hydroxyapatite surface by perforating collagen fibres.

A complete cement mantle is important for the longevity of a total hip replacement. In the minimally-invasive direct anterior approach used at the Innsbruck University hospital, the femoral component has to be inserted into the femoral canal by an angulated movement. In a cadaver study, the quality and the extent of the cement mantle surrounding 13 Exeter femoral components implanted straight through a standard anterolateral transgluteal approach were compared with those of 13 similar femoral components implanted in an angulated fashion through a direct anterior approach. A third-generation cementing technique was used. The inner and outer contours of the cement mantles was traced from CT scans and the thickness and cross-sectional area determined.

In no case was the cement mantle incomplete. The total mean thickness of the cement mantle was 3.62 mm (95% confidence interval 3.59 to 3.65). The mean thickness in the group using the minimally-invasive approach was 0.16 mm less than that in the anterolateral group. The distribution of the thickness was similar in the two groups. The mean thickness was less on the anteromedial and anterolateral aspect than on the posterior aspect of the femur.

There is no evidence that the angulated introduction of Exeter femoral components in the direct anterior approach in cadavers compromises the quality, extent or thickness of the cement mantle.

Different calcaneal plates with locked screws were compared in an experimental model of a calcaneal fracture. Four plate models were tested, three with uniaxially-locked screws (Synthes, Newdeal, Darco), and one with polyaxially-locked screws (90° ± 15°) (Rimbus). Synthetic calcanei were osteotomised to create a fracture model and then fixed with the plates and screws. Seven specimens for each plate model were subjected to cyclic loading (preload 20 N, 1000 cycles at 800 N, 0.75 mm/s), and load to failure (0.75 mm/s).

During cyclic loading, the plate with polyaxially-locked screws (Rimbus) showed significantly lower displacement in the primary loading direction than the plates with uniaxially-locked screws (mean values of maximum displacement during cyclic loading: Rimbus, 3.13 mm (sd 0.68); Synthes, 3.46 mm (sd 1.25); Darco, 4.48 mm (sd 3.17); Newdeal, 5.02 mm (sd 3.79); one-way analysis of variance, p < 0.001).

The increased stability of a plate with polyaxially-locked screws demonstrated during cyclic loading compared with plates with uniaxially-locked screws may be beneficial for clinical use.