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.

Intra-articular punctures and injections are performed routinely on patients with injuries to and chronic diseases of joints, to release an effusion or haemarthrosis, or to inject drugs. The purpose of this study was to investigate the accuracy of placement of the needle during this procedure.

A total of 76 cadaver acromioclavicular joints were injected with a solution containing methyl blue and subsequently dissected to distinguish intra- from peri-articular injection. In order to assess the importance of experience in achieving accurate placement, half of the injections were performed by an inexperienced resident and half by a skilled specialist. The specialist injected a further 20 cadaver acromioclavicular joints with the aid of an image intensifier. The overall frequency of peri-articular injection was much higher than expected at 43% (33 of 76) overall, with 42% (16 of 38) by the specialist and 45% (17 of 38) by the resident. The specialist entered the joint in all 20 cases when using the image intensifier.

Correct positioning of the needle in the joint should be facilitated by fluoroscopy, thereby guaranteeing an intra-articular injection.

We aimed to document the pre-operative expectations in Korean patients undergoing total knee replacement using an established survey form and to determine whether expectations were influenced by sociodemographic factors or pre-operative functional status. Expectations regarding 17 items in the Knee Replacement Expectation Survey form were investigated in 454 patients scheduled for total knee replacement. The levels and distribution patterns of summated expectation and of five expectation categories (relief from pain, baseline activity, high flexion activity, social activity and psychological well-being) constructed from the 17 items were assessed. Univariate analyses and multivariate logistic regression were performed to examine the associations of expectations with the sociodemographic factors and the functional status.

The top three expectations were relief from pain, restoration of walking ability, and psychological well-being. Of the five expectation categories, relief from pain was ranked the highest, followed by psychological well-being, restoration of baseline activity, ability to perform high flexion activities and ability to participate in social activities. An age of < 65 years, being employed, a high Western Ontario and McMaster Universities osteoarthritis index function score and a low Short-form 36 social score were found to be significantly associated with higher overall expectations.

Antibiotic prophylaxis is routinely administered during joint replacement surgery and may predispose patients to Clostridium difficile-associated disease (CDAD). The primary aim of this study was to determine the incidence of this following joint replacement, using a cefuroxime-based regimen. Patients developing CDAD were compared with a control group of patients without CDAD. The incidence of the former was 1.7 per 1000 primary joint replacements. Those patients prescribed additional antibiotics had a higher incidence of CDAD (p = 0.047), but there was no difference between the two groups in relation to the use of gastroprotective agents (p = 0.703). A trial of a new prophylaxis regimen would require 43 198 patients in each arm to show a reduction of one case per 1000 procedures. Cefuroxime-based antibiotic prophylaxis is safe in patients undergoing primary elective joint replacement.

We compared the outcome of closed intramedullary nailing with minimally invasive plate osteosynthesis using a percutaneous locked compression plate in patients with a distal metaphyseal fracture in a prospective study.

A total of 85 patients were randomised to operative stabilisation either by a closed intramedullary nail (44) or by minimally invasive osteosynthesis with a compression plate (41). Pre-operative variables included the patients’ age and the side and pattern of the fracture. Peri-operative variables were the operating time and the radiation time. Postoperative variables were wound problems, the time to union of the fracture, the functional American Orthopaedic Foot and Ankle surgery score and removal of hardware.

We found no significant difference in the pre-operative variables or in the time to union in the two groups. However, the mean radiation time and operating time were significantly longer in the locked compression plate group (3.0 vs 2.12 minutes, p < 0.001, and 97.9 vs 81.2 minutes, p < 0.001, respectively). After one year, all the fractures had united. Patients who had intramedullary nailing had a higher mean pain score, but better function, alignment and total American Orthopaedic Foot and Ankle surgery scores, although the differences were not statistically significant (p = 0.234, p = 0.157, p = 0.897, p = 0.177 respectively). Three (6.8%) patients in the intramedullary nailing group and six (14.6%) in the locked compression plate group showed delayed wound healing, and 37 (84.1%) in the former group and 38 (92.7%) in the latter group expressed a wish to have the implant removed.

We conclude that both closed intramedullary nailing and a percutaneous locked compression plate can be used safely to treat Orthopaedic Trauma Association type-43A distal metaphyseal fractures of the tibia. However, closed intramedullary nailing has the advantage of a shorter operating and radiation time and easier removal of the implant. We therefore prefer closed intramedullary nailing for patients with these fractures.

The purposes of this study were to define the range of laxity of the interosseous ligaments in cadaveric wrists and to determine whether this correlated with age, the morphology of the lunate, the scapholunate (SL) gap or the SL angle. We evaluated 83 fresh-frozen cadaveric wrists and recorded the SL gap and SL angle. Standard arthroscopy of the wrist was then performed and the grades of laxity of the scapholunate interosseous ligament (SLIL) and the lunotriquetral interosseous ligament (LTIL) and the morphology of the lunate were recorded. Arthroscopic evaluation of the SLIL revealed four (5%) grade I specimens, 28 (34%) grade II, 40 (48%) grade III and 11 (13%) grade IV. Evaluation of the LTIL showed 17 (20%) grade I specimens, 40 (48%) grade II, 28 (30%) grade III and one (1%) grade IV.

On both bivariate and multivariate analysis, the grade of both the SLIL and LTIL increased with age, but decreased with female gender. The grades of SLIL or LTIL did not correlate with the morphology of the lunate, the SL gap or the SL angle. The physiological range of laxity at the SL and lunotriquetral joints is wider than originally described. The intercarpal ligaments demonstrate an age-related progression of laxity of the SL and lunotriquetral joints. There is no correlation between the grades of laxity of the SLIL or LTIL and the morphology of the lunate, the SL gap or the SL grade. Based on our results, we believe that the Geissler classification has a role in describing intercarpal laxity, but if used alone it cannot adequately diagnose pathological instability.

We suggest a modified classification with a mechanism that may distinguish physiological laxity from pathological instability.

The management of radial nerve palsy associated with fractures of the shaft of the humerus has been disputed for several decades. This study has systematically reviewed the published evidence and developed an algorithm to guide management. We searched web-based databases for studies published in the past 40 years and identified further pages through manual searches of the bibliography in papers identified electronically. Of 391 papers identified initially, encompassing a total of 1045 patients with radial nerve palsy, 35 papers met all our criteria for eligibility. Meticulous extraction of the data was carried out according to a preset protocol.

The overall prevalence of radial nerve palsy after fracture of the shaft of the humerus in 21 papers was 11.8% (532 palsies in 4517 fractures). Fractures of the middle and middle-distal parts of the shaft had a significantly higher association with radial nerve palsy than those in other parts. Transverse and spiral fractures were more likely to be associated with radial nerve palsy than oblique and comminuted patterns of fracture (p < 0.001). The overall rate of recovery was 88.1% (921 of 1045), with spontaneous recovery reaching 70.7% (411 of 581) in patients treated conservatively. There was no significant difference in the final results when comparing groups which were initially managed expectantly with those explored early, suggesting that the initial expectant treatment did not affect the extent of nerve recovery adversely and would avoid many unnecessary operations. A treatment algorithm for the management of radial nerve palsy associated with fracture of the shaft of the humerus is recommended by the authors.

We compared 55 consecutive total hip replacements performed on 53 morbidly obese patients with osteoarthritis with a matched group of 55 total hip replacements in 53 non-obese patients. The groups were matched for age, gender, prosthesis type, laterality and preoperative Harris Hip Score. They were followed prospectively for five years and the outcomes were assessed using the Harris Hip Score, the Short-form 36 score and radiological findings.

Survival at five years using revision surgery as an endpoint, was 90.9% (95% confidence interval 82.9 to 98.9) for the morbidly obese and 100% for the non-obese patients. The Harris Hip and the Short-form 36 scores were significantly better in the non-obese group (p < 0.001). The morbidly obese patients had a higher rate of complications (22% vs 5%, p = 0.012), which included dislocation and both superficial and deep infection.

In light of these inferior results, morbidly obese patients should be advised to lose weight before undergoing a total hip replacement, and counselled regarding the complications. Despite these poorer results, however, the patients have improved function and quality of life.

We investigated the excess mortality risk associated with fractures of the hip. Data related to 29 134 patients who underwent surgery following a fracture of the hip were obtained from the Scottish Hip Fracture Audit database. Fractures due to primary or metastatic malignancy were excluded. An independent database (General Register Office (Scotland)) was used to validate dates of death. The observed deaths per 100 000 of the population were then calculated for each group (gender, age and fracture type) at various time intervals up to eight years. A second database (Interim Life Tables for Scotland, Scottish Government) was then used to create standardised mortality ratios. Analysis showed that mortality in patients aged > 85 years with a fracture of the hip tended to return to the level of the background population between two and five years after the fracture. In those patients aged < 85 years excess mortality associated with hip fracture persisted beyond eight years. Extracapsular hip fractures and male gender also conferred increased risk.

In order to determine the epidemiology of adult scoliosis in the elderly and to analyse the radiological parameters and symptoms related to adult scoliosis, we carried out a prospective cross-sectional radiological study on 1347 adult volunteers. There were 615 men and 732 women with a mean age of 73.3 years (60 to 94), and a mean Cobb angle of 7.55° (sd 5.95).

In our study, 478 subjects met the definition of scoliosis (Cobb angle ≥10°) showing a prevalence of 35.5%. There was a significant difference in the epidemiological distribution and prevalence between the age and gender groups. The older adults showed a larger prevalence and more severe scoliosis, more prominent in women (p = 0.004). Women were more affected by adult scoliosis and showed more linear correlation with age (p < 0.001). Symptoms were more severe in those with scoliosis than in the normal group, but were similar between the mild, moderate and severe scoliosis groups (p = 0.224) and between men and women (p = 0.231).

Adult scoliosis showed a significant relationship with lateral listhesis, vertebral rotation, lumbar hypolordosis, sagittal imbalance and a high level of the L4–5 disc (p < 0.0001, p < 0.0001, p = 0.002, p = 0.002, p < 0.0001 respectively). Lateral listhesis, lumbar hypolordosis and sagittal imbalance were related to symptoms (p < 0.0001, p = 0.001, p < 0.0001 respectively).

In a prospective, randomised study on the repair of tears of the rotator cuff we compared the clinical results of two suture techniques for which different suture materials were used.

We prospectively randomised 100 patients with tears of the rotator cuff into two groups. Group 1 had transosseous repair with No. 3 Ethibond using modified Mason-Allen sutures and group 2 had transosseous repair with 1.0 mm polydioxanone cord using modified Kessler sutures. After 24 to 30 months the patients were evaluated clinically using the Constant score and by ultrasonography.

Of the 100 patients, 92 completed the study. No significant statistical difference was seen between the two groups: Constant score, 91% vs 92%; rate of further tear, 18% vs 22%; and revision, 4% vs 4%. In cases of further tear the outcome in group 2 did not differ from that for the intact repairs (91% vs 91%), but in group 1 it was significantly worse (94% vs 77%, p = 0.005).

Overall, seven patients had complications which required revision surgery, in four for pain (two in each group) and in three for infection (two in group 1 and one in group 2).

Our aim was to determine the effect of the initial pattern of fracture and the displacement of fragments on the outcome of proximal humeral fractures treated conservatively. We followed 93 consecutive patients prospectively for one year. Final movement and strength were compared with those of the contralateral side. The final American Shoulder and Elbow Society score and the Disabilities of Arm, Shoulder and Hand and Short-Form 36 questionnaires were compared with those provided by the patient on the day of the injury. Radiographs and CT scans with three-dimensional reconstruction were obtained in all patients. The pattern of the fracture and the displacement of individual fragments were analysed and correlated with the final outcome. There were two cases of nonunion and six of avascular necrosis. The majority of the fractures (84 patients; 90%) followed one of the following four patterns: posteromedial (varus) impaction in 50 patients (54%), lateral (valgus) impaction in 13 (14%), isolated greater tuberosity in 15 (16%), and anteromedial impaction fracture in six (6%). Head orientation, impaction of the surgical neck and displacement of the tuberosity correlated strongly with the outcome.

In fractures with posteromedial impaction, a poor outcome was noted as the articular surface displaced inferiorly increasing its distance from the acromion. A poorer outcome was noted as a fractured greater tuberosity displaced medially overlapping with the posterior articular surface. Lateral impaction fractures had a worse outcome than other patterns of fracture.

We investigated the wear characteristics and clinical performance of four different total hip joint articulations in 114 patients. Wear and migration was measured by roentgenstereophotogrammetric analysis at five years or at the last follow-up. The mean annual wear was 0.11 mm for a stainless steel/Enduron articulation, 0.34 mm for stainless steel/Hylamer cup, 0.17 mm for zirconium oxide ceramic/Enduron and 0.40 mm for zirconium oxide ceramic/Hylamer. The difference between the groups was significant (p < 0.008) except for stainless steel/Hylamer vs zirconium oxide ceramic/Hylamer (p = 0.26).

At present, 12 patients have undergone a revision procedure, four at five years and eight thereafter. No patient who received a stainless steel/Enduron articulation at their primary replacement required revision.

Conflicting results have been reported about the performance of the zirconium oxide ceramic femoral head, but our findings suggest that it should not be used with a polymethylmethacrylate acetabular component. Hylamer has already been withdrawn from the market.

Bone mineral density (BMD) around the femoral component has been reported to decrease after total knee replacement (TKR) because of stress shielding. Our aim was to determine whether a cemented mobile-bearing component reduced the post-operative loss of BMD. In our study 28 knees receiving a cemented fixed-bearing TKR were matched with 28 receiving a cemented mobile-bearing TKR. They underwent dual-energy x-ray absorptiometry, pre-operatively and at three weeks and at three, six, 12, 18 and 24 months post-operatively. The patients were not taking medication to improve the BMD.

The pre-operative differences in the BMD of the femoral neck, wrist, lumbar spine and knee in the two groups were not significant. The BMD of the femur decreased postoperatively in the fixed-bearing group, but not the mobile-bearing group. The difference in the post-operative change in the BMD in the two groups was statistically significant (p < 0.05) at 18 and 24 months.

Our findings show that a cemented mobile-bearing TKR has a favourable effect on the BMD of the distal femur after TKR in the short term. Further study is required to determine the long-term effects.

Between 1988 and 1998 we implanted 318 total hip replacements (THRs) in 287 patients using the Plasmacup (B. Braun Ltd, Sheffield, United Kingdom) and a conventional metal-on-polyethylene articulation. The main indications for THR were primary or secondary osteoarthritis.

At follow-up after a mean 11.6 years (7.6 to 18.4) 17 patients had died and 20 could not be traced leaving a final series of 280 THRs in 250 patients. There were 62 revisions (22.1%) in 59 patients. A total of 43 acetabular shells (15.4%) had been revised and 13 (4.6%) had undergone exchange of the liner. The most frequent indications for revision were osteolysis and aseptic loosening, followed by polyethylene wear. The mean Kaplan-Meier survival of the Plasmacup was 91% at ten years and 58% at 14 years. Osteolysis was found around 36 (17.1%) of the 211 surviving shells. The median annual rate of linear wear in the surviving shells was 0.12 mm/year and 0.25 mm/year in those which had been revised (p < 0.001). Polyethylene wear was a strong independent risk factor for osteolysis and aseptic loosening. The percentage of patients with osteolysis increased proportionately with each quintile of wear-rate.

There is a high late rate of failure of the Plasmacup. Patients with the combination of this prosthesis and bearing should be closely monitored after ten years.

Revision surgery of the hip was performed on 114 hips using an extensively porous-coated femoral component. Of these, 95 hips (94 patients) had a mean follow-up of 10.2 years (5 to 17). No cortical struts were used and the cortical index and the femoral cortical width were measured at different levels.

There were two revisions for aseptic loosening. Survivorship at 12 years for all causes of failure was 96.9% (95% confidence interval 93.5 to 100) in the best-case scenario. Fibrous or unstable fixation was associated with major bone defects. The cortical index (p = 0.045) and the lateral cortical thickness (p = 0.008) decreased at the proximal level over time while the medial cortex increased (p = 0.001) at the proximal and distal levels. An increase in the proximal medial cortex was found in patients with an extended transtrochanteric osteotomy (p = 0.026) and in those with components shorter than 25 cm (p = 0.008).

The use of the extensively porous-coated femoral component can provide a solution for difficult cases in revision surgery. Radiological bony ingrowth is common. Although without clinical relevance at the end of follow-up, the thickness of the medial femoral cortex often increased while that of the lateral cortex decreased. In cases in which a shorter component was used and in those undertaken using an extended trochanteric osteotomy, there was a greater increase in thickness of the femoral cortex over time.

Endoprosthetic reconstruction following resection of 31 tumours of the proximal femur in 30 patients was performed using a Wagner SL femoral revision stem. The mean follow-up was 25.6 months (0.6 to 130.0). Of the 28 patients with a metastasis, 27 died within a mean follow-up period of 18.1 months (0.6 to 56.3) after the operation, and the remaining patient was excluded from the study 44.4 months post-operatively when the stem was removed. The two patients with primary bone tumours were still alive at the latest follow-up of 81.0 and 130.0 months, respectively. One stem only was removed for suspected low-grade infection 44.4 months post-operatively. The worst-case survival rate with removal of the stem for any cause and/or loss to follow-up was 80.0% (95% confidence interval 44.9 to 100) at 130.0 months. The mean Karnofsky index increased from 44.2% (20% to 70%) pre-operatively to 59.7% (0% to 100%) post-operatively, and the mean Merle d’Aubigné score improved from 4.5 (0 to 15) to 12.0 (0 to 18). The mean post-operative Musculoskeletal Tumour Society score was 62.4% (3.3% to 100%).

The Wagner SL femoral revision stem offers an alternative to special tumour prostheses for the treatment of primary and secondary tumours of the proximal femur. The mid-term results are very promising, but long-term experience is necessary.

We reviewed the rate of revision of unicompartmental knee replacements (UKR) from the New Zealand Joint Registry between 1999 and 2008. There were 4284 UKRs, of which 236 required revision, 205 to a total knee replacement (U2T) and 31 to a further unicompartmental knee replacement (U2U). We used these data to establish whether the survival and functional outcome for revised UKRs were comparable with those of primary total knee replacement (TKR). The rate of revision for the U2T cohort was four times higher than that for a primary TKR (1.97 vs 0.48; p < 0.05). The mean Oxford Knee Score was also significantly worse in the U2T group than that of the primary TKR group (30.02 vs 37.16; p < 0.01). The rate of revision for conversion of a failed UKR to a further UKR (U2U cohort) was 13 times higher than that for a primary TKR.

The poor outcome of a UKR converted to a primary TKR compared with a primary TKR should contra-indicate the use of a UKR as a more conservative procedure in the younger patient.

There is no diagnostic, non-invasive method for the early detection of loosening after total hip arthroplasty. In a pilot study, we have analysed two serum markers of bone remodelling, procollagen I C-terminal extension peptide (PICP) and cross-linked N-terminal telopeptide (NTx), as well as the diagnostic performance of NTx for the assessment of osteolysis. We recruited 21 patients with loosening (group I), 18 with a well-fixed prosthesis (group II) and 17 at the time of primary arthroplasty for osteoarthritis (OA) (group III). Internal normal reference ranges were obtained from 30 healthy subjects (group IV).

The serum PICP level was found to be significantly lower in patients with OA and those with loosening, when compared with those with stable implants, while the NTx level was significantly increased only in the group with loosening, suggesting that collagen degradation depended on the altered bone turnover induced by the implant. This hypothesis was reinforced by the finding that the values in the pre-surgery patients and stable subjects were comparable with the reference range of younger healthy subjects.

A high specificity and positive predictive value for NTx provided good diagnostic evidence of agreement between the test and the clinical and radiological evaluations. The NTx level could be used to indicate stability of the implant. However, further prospective, larger studies are necessary.

We present data relating to the Bryan disc arthroplasty for the treatment of cervical spondylosis in 46 patients.

Patients with either radiculopathy or myelopathy had a cervical discectomy followed by implantation of a cervical disc prosthesis. Patients were reviewed at six weeks, six months and one year and assessment included three outcome measures, a visual analogue scale (VAS), the short form 36 (SF-36) and the neck disability index (NDI). The results were categorised according to a modification of Odom’s criteria. Radiological evaluation, by an independent radiologist, sought evidence of movement, stability and subsidence of the prosthesis.

A highly significant difference was found for all three outcome measurements, comparing the pre-operative with the post-operative values: VAS (Z = 6.42, p < 0.0001), SF-36 (mental component) (Z = −5.02, p < 0.0001), SF-36 (physical component) (Z = −5.00, p < 0.0001) and NDI (Z = 7.03, p < 0.0001). The Bryan cervical disc prosthesis seems reliable and safe in the treatment of patients with cervical spondylosis.