Multicentre clinical trials in trauma care are gaining prominence as a means of generating good-quality evidence to inform and influence clinical practice. We believe multicentre trials have an important role to play in supporting evidence-based practice, and further investment in such trials is justified.

A group of 109 patients with unilateral low back pain for over three months were randomised to receive one of three types of injection treatment: cortisone and local anaesthetic injected into two facet joints (28), the same mixture around two facet joints (39), or physiological saline into two facet joints (42). The effect of the treatment was evaluated in relation to work attendance, pain, disability and movements of the lumbar spine. Patients were examined one hour and two and six weeks after treatment and also completed a questionnaire after three months. A significant improvement was observed in work attendance, pain and disability scores, but this was independent of the treatment given and movements of the lumbar spine were not improved. Of the 70 patients with initial pain relief after injection, 36% reported persisting benefit at the three month follow-up, independent of the mode of treatment given. We conclude that facet joint injection is a non-specific method of treatment and the good results depend on a tendency to spontaneous regression and to the psychosocial aspects of back pain.

We performed a randomised trial on 37 hips (33 patients) with early-stage osteonecrosis (ON). After the initial clinical evaluation, including plain radiography and MRI, 18 hips were randomly assigned to a core-decompression group and 19 to a conservatively-treated group. All the patients were regularly followed up by clinical evaluation, plain radiography and MRI at intervals of three months. Hip pain was relieved in nine out of ten initially symptomatic hips in the core-decompression group but persisted in three out of four initially painful hips in the conservatively-treated group at the second assessment (p < 0.05). At a minimum follow-up of 24 months, 14 of the 18 core-decompressed hips (78%) and 15 of the 19 non-operated hips (79%) developed collapse of the femoral head. By survival analysis, there was no significant difference in the time to collapse between the two groups (log-rank test p = 0.79). Core decompression may be effective tin symptomatic relief, but is of no greater value than conservative management in preventing collapse in early osteonecrosis of the femoral head.

Aims

Torus fractures are the most common childhood fracture, accounting for 500,000 UK emergency attendances per year. UK treatment varies widely due to lack of scientific evidence. This is the protocol for a randomized controlled equivalence trial of ‘the offer of a soft bandage and immediate discharge’ versus ‘rigid immobilization and follow-up as per the protocol of the treating centre’ in the treatment of torus fractures .

Routine prophylaxis for venous thromboembolic disease after total hip replacement (THR) is recommended. Pneumatic compression with foot pumps seems to provide an alternative to chemical agents. However, the overall number of patients investigated in randomised clinical trials has been too small to draw evidence-based conclusions. This randomised clinical trial was carried out to compare the effectiveness and safety of mechanical versus chemical prophylaxis of DVT in patients after THR. Inclusion criteria were osteoarthritis of the hip and age less than 80 years. Exclusion criteria included a history of thromboembolic disease, heart disease, and bleeding diatheses. There were 216 consecutive patients considered for inclusion in the trial who were randomised either for management with the A-V Impulse System foot pump. We excluded 16 patients who did not tolerate continuous use of the foot pump or with low-molecular-weight heparin (LMWH). Patients were monitored for DVT using serial duplex sonography at 3, 10 and 45 days after surgery. DVT was detected in three of 100 patients in the foot-pump group and with six of 100 patients in the LMWH group (p < 0.05). The mean post-operative drainage was 259 ml in the foot-pump group and 328 ml in the LMWH group (p < 0.05). Patients in the foot-pump group had less swelling of the thigh (10 mm compared with 15 mm; p < 0.05). One patient developed heparin-induced thrombocytopenia. This study confirms the effectiveness and safety of mechanical prophylaxis of DVT in THR. Some patients cannot tolerate the foot pump

Aims. In a multicentre, randomised study of adolescents undergoing posterior spinal fusion for idiopathic scoliosis, we investigated the effect of adding gelatine matrix with human thrombin to the standard surgical methods of controlling blood loss. Patients and Methods. Patients in the intervention group (n = 30) were randomised to receive a minimum of two and a maximum of four units of gelatine matrix with thrombin in addition to conventional surgical methods of achieving haemostasis. Only conventional surgical methods were used in the control group (n = 30). We measured the intra-operative and total blood loss (intra-operative blood loss plus post-operative drain output). Results. Each additional hour of operating time increased the intra-operative blood loss by 356.9 ml (p < 0.001) and the total blood loss by 430.5 ml (p < 0.001). Multiple linear regression analysis showed that the intervention significantly decreased the intra-operative (-171 ml, p = 0.025) and total blood loss (-177 ml, p = 0.027). The decrease in haemoglobin concentration from the day before the operation to the second post-operative day was significantly smaller in the intervention group (-6 g/l, p = 0.013) than in the control group. . Conclusion. The addition of gelatine matrix with human thrombin to conventional methods of achieving haemostasis reduces both the intra-operative blood loss and the decrease in haemoglobin concentration post-operatively in adolescents undergoing posterior spinal fusion for idiopathic scoliosis. Take home message: A randomised clinical trial showed that gelatine matrix with human thrombin decreases intra-operative blood loss by 30% when added to traditional surgical haemostatic methods in adolescents undergoing posterior spinal fusion for idiopathic scoliosis. Cite this article: Bone Joint J 2016;98-B:395–401

We undertook a randomised clinical trial to compare treatment times and failure rates between above- and below-knee Ponseti casting groups. Eligible children with idiopathic clubfoot, treated using the Ponseti method, were randomised to either below- or above-knee plaster of Paris casting. Outcome measures were total treatment time and the occurrence of failure, defined as two slippages or a treatment time above eight weeks. A total of 26 children (33 feet) were entered into the trial. The above-knee group comprised 17 feet in 13 children (ten boys and three girls, median age 13 days (1 to 40)) and the below-knee group comprised 16 feet in 13 children (ten boys and three girls, median age 13 days (5 to 20)). Because of six failures (37.5%) in the below-knee group, the trial was stopped early for ethical reasons. The rate of failure was significantly higher in the below-knee group (p = 0.039). The median treatment times of six weeks in the below-knee and four weeks in the above-knee group differed significantly (p = 0.01). This study demonstrates that the use of a below-knee plaster of Paris cast in conjunction with the Ponseti technique leads to unacceptably high failure rates and significantly longer treatment times. Therefore, this technique is not recommended. Cite this article: Bone Joint J 2013;95-B:1570–4

Valgus high tibial osteotomy for osteoarthritis of the medial compartment of the knee can be performed using medial opening- and lateral closing-wedge techniques. The latter have been thought to offer greater initial stability. We measured and compared the stability of opening- and closing-wedge osteotomies fixed by TomoFix plates using radiostereometry in a series of 42 patients in a prospective, randomised clinical trial. There were no differences between the opening- and closing-wedge groups in the time to regain knee function and full weight-bearing. Pain and knee function were significantly improved in both groups without any differences between them. All the osteotomies united within one year. Radiostereometry showed no clinically relevant movement of bone or differences between either group. Medial opening-wedge high tibial osteotomy secured by a TomoFix plate offers equal stability to a lateral closing-wedge technique. Both give excellent initial stability and provide significantly improved knee function and reduction in pain, although the opening-wedge technique was more likely to produce the intended correction

A new generation of knee prostheses has been introduced with the intention of improving post-operative knee flexion. In order to evaluate whether this goal has been achieved we performed a systematic review and meta-analysis. Systematic literature searches were conducted on MEDLINE and EMBASE from their inception to December 2007, and proceedings of scientific meetings were also searched. Only randomised, clinical trials were included in the meta-analysis. The mean difference in the maximum post-operative flexion between the ‘high-flex’ and conventional types of prosthesis was defined as the primary outcome measure. A total of five relevant articles was identified. Analysis of these trials suggested that no clinically relevant or statistically significant improvement was obtained in flexion with the ‘high-flex’ prostheses. The weighted mean difference was 2.1° (95% confidence interval −0.2 to +4.3; p = 0.07)

Aims. The PROximal Fracture of the Humerus Evaluation by Randomisation (PROFHER) randomised clinical trial compared the operative and non-operative treatment of adults with a displaced fracture of the proximal humerus involving the surgical neck. The aim of this study was to determine the long-term treatment effects beyond the two-year follow-up. Patients and Methods. Of the original 250 trial participants, 176 consented to extended follow-up and were sent postal questionnaires at three, four and five years after recruitment to the trial. The Oxford Shoulder Score (OSS; the primary outcome), EuroQol 5D-3L (EQ-5D-3L), and any recent shoulder operations and fracture data were collected. Statistical and economic analyses, consistent with those of the main trial were applied. Results. OSS data were available for 164, 155 and 149 participants at three, four and five years, respectively. There were no statistically or clinically significant differences between operative and non-operative treatment at each follow-up point. No participant had secondary shoulder surgery for a new complication. Analyses of EQ-5D-3L data showed no significant between-group differences in quality of life over time. Conclusion. These results confirm that the main findings of the PROFHER trial over two years are unchanged at five years. Cite this article: Bone Joint J 2017;99-B:383–92

This prospective randomised clinical trial evaluated the effect of alternatives for allogeneic blood transfusions after total hip replacement and total knee replacement in patients with pre-operative haemoglobin levels between 10.0 g/dl and 13.0 g/dl. A total of 100 patients were randomly allocated to the Eprex (pre-operative injections of epoetin) or Bellovac groups (post-operative retransfusion of shed blood). Allogeneic blood transfusions were administered according to hospital policy. In the Eprex group, 4% of the patients (two patients) received at least one allogeneic blood transfusion. In the Bellovac group, where a mean 216 ml (0 to 700) shed blood was retransfused, 28% (14 patients) required the allogeneic transfusion (p = 0.002). When comparing Eprex with Bellovac in total hip replacement, the percentages were 7% (two of 30 patients) and 30% (nine of 30 patients) (p = 0.047) respectively, whereas in total knee replacement, the percentages were 0% (0 of 20 patients) and 25% (five of 20 patients) respectively (p = 0.042). Pre-operative epoetin injections are more effective but more costly in reducing the need for allogeneic blood transfusions in mildly anaemic patients than post-operative retransfusion of autologous blood

This review summarises the evidence for the treatment of displaced fractures of the femoral neck in elderly patients. Results from randomised clinical trials and national register studies are presented when available. . The advantages of arthroplasty compared with internal fixation are supported by several studies. A number of studies contribute to the discussions of total hip arthroplasty (THA) versus hemiarthroplasty and unipolar versus bipolar hemiarthroplasty, but no clear-cut evidence-based recommendation can be made. THA may be particularly advantageous for active, lucid patients with a relatively long life expectancy. For patients who are physiologically older, hemiarthoplasty is probably satisfactory, and for the oldest patients with more comorbidities, unipolar implants are considered to be sufficient. If the hospital can support emergency THA surgery in sufficient numbers and quality, there may be few patients who warrant bipolar hemiarthroplasty. . The direct lateral approach reduces the risk of dislocation compared with the posterior approach. Cemented implants lower the risk of periprosthetic fracture and its subsequent morbidity and mortality. As the risk of peri-operative death related to bone cement can be reduced by adequate measures, cemented implants are recommended in fracture cases. Take home message: There remains a great variation in the surgical management of patients with a hip fracture, and an evidence-based approach should improve the outcomes for this vulnerable patient group. Cite this article: Bone Joint J 2016;98-B:291–7

Aims. We chose unstable extra-capsular hip fractures as our study group because these types of fractures suffer the largest blood loss. We hypothesised that tranexamic acid (TXA) would reduce total blood loss (TBL) in extra-capsular fractures of the hip. . Patients and Methods. A single-centre placebo-controlled double-blinded randomised clinical trial was performed to test the hypothesis on patients undergoing surgery for extra-capsular hip fractures. For reasons outside the control of the investigators, the trial was stopped before reaching the 120 included patients as planned in the protocol. . Results. In all 72 patients (51 women, 21 men; 33 patients in the TXA group, 39 in the placebo group) were included in the final analysis, with a significant mean reduction of 570.8 ml (p = 0.029) in TBL from 2100.4 ml (standard deviation (. sd). = 1152.6) in the placebo group to 1529.6 ml (. sd. = 1012.7) in the TXA group. . The 90-day mortality was 27.2% (n = 9) in the TXA group and 10.2% (n = 4) in the placebo group (p = 0.07). We were not able to ascertain a reliable cause of death in these patients. . Discussion. TXA significantly reduced TBL in extra-capsular hip fractures, but concerns regarding its safety in this patient group must be investigated further before the use of TXA can be recommended. Take home message: We present a randomised clinical trial that is unique in the literature. We evaluate the effect of TXA in very homogenous population - extra-capsular fractures operated with short intramedullary nails. Cite this article: Bone Joint J 2016;98-B:747–53

Objectives. Accurate characterisation of fractures is essential in fracture management trials. However, this is often hampered by poor inter-observer agreement. This article describes the practicalities of defining the fracture population, based on the Neer classification, within a pragmatic multicentre randomised controlled trial in which surgical treatment was compared with non-surgical treatment in adults with displaced fractures of the proximal humerus involving the surgical neck. Methods. The trial manual illustrated the Neer classification of proximal humeral fractures. However, in addition to surgical neck displacement, surgeons assessing patient eligibility reported on whether either or both of the tuberosities were involved. Anonymised electronic versions of baseline radiographs were sought for all 250 trial participants. A protocol, data collection tool and training presentation were developed and tested in a pilot study. These were then used in a formal assessment and classification of the trial fractures by two independent senior orthopaedic shoulder trauma surgeons. Results. Two or more baseline radiographic views were obtained for each participant. The independent raters confirmed that all fractures would have been considered for surgery in contemporaneous practice. A full description of the fracture population based on the Neer classification was obtained. The agreement between the categorisation at baseline (tuberosity involvement) and Neer classification as assessed by the two raters was only fair (kappa 0.29). However, this disparity did not appear to affect trial findings, specifically in terms of influencing the effect of treatment on the primary outcome of the trial. Conclusions. A key reporting requirement, namely the description of the fracture population, was achieved within the context of a pragmatic multicentre randomised clinical trial. This article provides important guidance for researchers designing similar trials on fracture management. Cite this article: H. H. G. Handoll, S. D. Brealey, L. Jefferson, A. Keding, A. J. Brooksbank, A. J. Johnstone, J. J. Candal-Couto, A. Rangan. Defining the fracture population in a pragmatic multicentre randomised controlled trial: PROFHER and the Neer classification of proximal humeral fractures.Bone Joint Res 2016;5:481–489. DOI: 10.1302/2046-3758.510.BJR-2016-0132.R1

Objectives. This study reports on a secondary exploratory analysis of the early clinical outcomes of a randomised clinical trial comparing robotic arm-assisted unicompartmental knee arthroplasty (UKA) for medial compartment osteoarthritis of the knee with manual UKA performed using traditional surgical jigs. This follows reporting of the primary outcomes of implant accuracy and gait analysis that showed significant advantages in the robotic arm-assisted group. Methods. A total of 139 patients were recruited from a single centre. Patients were randomised to receive either a manual UKA implanted with the aid of traditional surgical jigs, or a UKA implanted with the aid of a tactile guided robotic arm-assisted system. Outcome measures included the American Knee Society Score (AKSS), Oxford Knee Score (OKS), Forgotten Joint Score, Hospital Anxiety Depression Scale, University of California at Los Angeles (UCLA) activity scale, Short Form-12, Pain Catastrophising Scale, somatic disease (Primary Care Evaluation of Mental Disorders Score), Pain visual analogue scale, analgesic use, patient satisfaction, complications relating to surgery, 90-day pain diaries and the requirement for revision surgery. Results. From the first post-operative day through to week 8 post-operatively, the median pain scores for the robotic arm-assisted group were 55.4% lower than those observed in the manual surgery group (p = 0.040). At three months post-operatively, the robotic arm-assisted group had better AKSS (robotic median 164, interquartile range (IQR) 131 to 178, manual median 143, IQR 132 to 166), although no difference was noted with the OKS. At one year post-operatively, the observed differences with the AKSS had narrowed from a median of 21 points to a median of seven points (p = 0.106) (robotic median 171, IQR 153 to 179; manual median 164, IQR 144 to 182). No difference was observed with the OKS, and almost half of each group reached the ceiling limit of the score (OKS > 43). A greater proportion of patients receiving robotic arm-assisted surgery improved their UCLA activity score. Binary logistic regression modelling for dichotomised outcome scores predicted the key factors associated with achieving excellent outcome on the AKSS: a pre-operative activity level > 5 on the UCLA activity score and use of robotic-arm surgery. For the same regression modelling, factors associated with a poor outcome were manual surgery and pre-operative depression. Conclusion. Robotic arm-assisted surgery results in improved early pain scores and early function scores in some patient-reported outcomes measures, but no difference was observed at one year post-operatively. Although improved results favoured the robotic arm-assisted group in active patients (i.e. UCLA ⩾ 5), these do not withstand adjustment for multiple comparisons. Cite this article: M. J. G. Blyth, I. Anthony, P. Rowe, M. S. Banger, A. MacLean, B. Jones. Robotic arm-assisted versus conventional unicompartmental knee arthroplasty: Exploratory secondary analysis of a randomised controlled trial. Bone Joint Res 2017;6:631–639. DOI: 10.1302/2046-3758.611.BJR-2017-0060.R1

Intra-operative, peri-articular injection of local anaesthesia is an increasingly popular way of controlling pain following total knee replacement. At the same time, the problems associated with allogenic blood transfusion have led to interest in alternative methods for managing blood loss after total knee replacement, including the use of auto-transfusion of fluid from the patient’s surgical drain. It is safe to combine peri-articular infiltration with auto-transfusion from the drain. We performed a randomised clinical trial to compare the concentration of local anaesthetic in the blood and in the fluid collected in the knee drain in patients having either a peri-articular injection or a femoral nerve block. Clinically relevant concentrations of local anaesthetic were found in the fluid from the drains of patients having peri-articular injections (4.92 μg/ml (. sd. 3.151)). However, none of the patients having femoral nerve blockade had detectable levels. None of the patients in either group had clinically relevant concentrations of local anaesthetic in their blood after re-transfusion. The evidence from this study suggests that it is safe to use peri-articular injection in combination with auto-transfusion of blood from peri-articular drains during knee replacement surgery

Cervical spinal disc replacement is used in the management of degenerative cervical disc disease in an attempt to preserve cervical spinal movement and to prevent adjacent disc overload and subsequent degeneration. A large number of patients have undergone cervical spinal disc replacement, but the effectiveness of these implants is still uncertain. In most instances, degenerative change at adjacent levels represents the physiological progression of the natural history of the arthritic disc, and is unrelated to the surgeon. Complications of cervical disc replacement include loss of movement from periprosthetic ankylosis and ossification, neurological deficit, loosening and failure of the device, and worsening of any cervical kyphosis. Strict selection criteria and adherence to scientific evidence are necessary. Only prospective, randomised clinical trials with long-term follow-up will establish any real advantage of cervical spinal disc replacement over fusion

We performed a meta-analysis to evaluate the relative efficacy of regional and general anaesthesia in patients undergoing total hip or knee replacement. A comprehensive search for relevant studies was performed in PubMed (1966 to April 2008), EMBASE (1969 to April 2008) and the Cochrane Library. Only randomised studies comparing regional and general anaesthesia for total hip or knee replacement were included. We identified 21 independent, randomised clinical trials. A random-effects model was used to calculate all effect sizes. Pooled results from these trials showed that regional anaesthesia reduces the operating time (odds ratio (OR) −0.19; 95% confidence interval (CI) −0.33 to −0.05), the need for transfusion (OR 0.45; 95% CI 0.22 to 0.94) and the incidence of thromboembolic disease (deep-vein thrombosis OR 0.45, 95% CI 0.24 to 0.84; pulmonary embolism OR 0.46, 95% CI 0.29 to 0.80). Regional anaesthesia therefore seems to improve the outcome of patients undergoing total hip or knee replacement

A prospective randomised clinical trial was undertaken to compare biodegradable polyglycolic acid pins with standard Kirschner wires used to fix displaced elbow fractures in children. Twenty-four children were enrolled in the trial; 14 had fractures of the lateral condyle of the humerus, eight of the medial epicondyle and two had olecranon fractures. Eleven fractures were fixed with Kirschner wires and 13 with polyglycolic acid pins. Fracture union with full function occurred in all cases within six months. Kirschner wires caused problems including infection in three cases, soft-tissue ossification in one and they required removal under general anaesthesia in nine cases. No such complications occurred with polyglycolic acid pins but one patient in this group developed avascular necrosis and premature fusion of the medial epicondyle

In previous randomised clinical trials of thromboprophylaxis after total hip replacement, low-molecular-weight heparin has been given for an arbitrary 7 to 14 days. The risk factors are mainly perioperative and it is possible that a shorter course may be adequate. We assessed the safety and effectiveness of a three-day course. We assessed 156 primary THR patients after randomisation to either a control group or to receive enoxaparin at 12 hours preoperatively and 12 and 36 hours postoperatively. Thrombosis was diagnosed by routine venography. Haemorrhagic side-effects were assessed by measurement of blood loss, and soft-tissue side-effects by descriptive scores for wound discharge and bruising of the leg. The prevalence of calf thrombosis was 15.4% in the enoxaparin group and 32.1% in the control group (p = 0.01); the prevalence of proximal thrombosis was 15.4% and 17.9% respectively (not significant). There was no difference in haemorrhagic side-effects or wound discharge, but there was more bruising in the enoxaparin group

We performed a prospective, double-blind, randomised, clinical trial to investigate the efficacy of two regimes of rehabilitation for knees with anterior cruciate ligament deficiency (ACLD). Fifty ACLD patients were randomly allocated to one of two treatment groups: a programme of muscle strengthening (T) or a programme designed to enhance proprioception and improve hamstring contraction reflexes (P). An indirect measure of proprioception, the reflex hamstring contraction latency (RHCL), and a functional scoring system were used to record the status of the knee before and after the 12-week course of physiotherapy. Sagittal knee laxity was also measured. There was improvement in mean RHCL and in the mean functional score in both groups after treatment. The improvement in group P was significantly greater than that in group T. There was no significant change in joint laxity after treatment in either group. In both groups there was a positive correlation between improvement in RHCL and functional gain

In a prospective randomised clinical study acetabular components were implanted either freehand (n = 30) or using CT-based (n = 30) or imageless navigation (n = 30). The position of the component was determined post-operatively on CT scans of the pelvis. Following conventional freehand placement of the acetabular component, only 14 of the 30 were within the safe zone as defined by Lewinnek et al (40° inclination . sd. 10°; 15° anteversion . sd. 10°). After computer-assisted navigation 25 of 30 acetabular components (CT-based) and 28 of 30 components (imageless) were positioned within this limit (overall p < 0.001). No significant differences were observed between CT-based and imageless navigation (p = 0.23); both showed a significant reduction in variation of the position of the acetabular component compared with conventional freehand arthroplasty (p < 0.001). The duration of the operation was increased by eight minutes with imageless and by 17 minutes with CT-based navigation. Imageless navigation proved as reliable as that using CT in positioning the acetabular component

Autologous chondrocyte implantation (ACI) and mosaicplasty are both claimed to be successful for the repair of defects of the articular cartilage of the knee but there has been no comparative study of the two methods. A total of 100 patients with a mean age of 31.3 years (16 to 49) and with a symptomatic lesion of the articular cartilage in the knee which was suitable for cartilage repair was randomised to undergo either ACI or mosaicplasty; 58 patients had ACI and 42 mosaicplasty. Most lesions were post-traumatic and the mean size of the defect was 4.66 cm. 2. The mean duration of symptoms was 7.2 years and the mean number of previous operations, excluding arthroscopy, was 1.5. The mean follow-up was 19 months (12 to 26). Functional assessment using the modified Cincinatti and Stanmore scores and objective clinical assessment showed that 88% had excellent or good results after ACI compared with 69% after mosaicplasty. Arthroscopy at one year demonstrated excellent or good repairs in 82% after ACI and in 34% after mosaicplasty. All five patellar mosaicplasties failed. Our prospective, randomised, clinical trial has shown significant superiority of ACI over mosaicplasty for the repair of articular defects in the knee. The results for ACI are comparable with those in other studies, but those for mosaicplasty suggest that its continued use is of dubious value

We studied 1162 consecutive total hip replacements (THR) to establish the incidence of fatal pulmonary embolism (PE), clinical non-fatal PE and deep-vein thrombosis (DVT) in the six months after surgery. Chemical thromboprophylaxis had not been routinely used. We used a validated questionnaire supplemented by post-mortem records and a review of the clinical notes. Follow-up was 100%. The death rate from PE was 0.34% (95% CI 0.09 to 0.88), with one fatal PE after discharge 40 days after operation. The clinical PE rate confirmed by imaging was 1.20% (CI 0.65 to 2.02), with 0.7% of patients readmitted. The venographically-confirmed clinical DVT rate was 1.89% (CI 1.11 to 2.76), with 1.13% readmitted. The total thromboembolic morbidity was 3.4% (95% CI 2.5% to 4.7%); prophylaxis to reduce this would be justifiable if the complications of such prophylaxis did not produce an alternative morbidity. The fatal PE rate after THR without routine chemical prophylaxis was low; a very large randomised clinical trial would be required to demonstrate directly whether any prophylactic measure could reduce this. There is a large discrepancy between the high DVT rate reported in clinical trials using universal screening venography and the symptomatic DVT rate shown in this study. We found insufficient evidence to recommend continuing thromboprophylaxis after discharge from hospital

The role of modular tibial implants in total knee replacement is not fully defined. We performed a prospective randomised controlled clinical trial using radiostereophotogrammetric analysis to compare the performance of an all-polyethylene tibia with a metal-backed cruciate-retaining condylar design, PFC-∑ total knee replacement for up to 24 months. There were 51 patients who were randomised into two treatment groups. There were 10 subsequent withdrawals, leaving 21 all-polyethylene and 20 metal-backed tibial implants. No patient was lost to follow-up. There were no significant demographic differences between the groups. At two years one metal-backed implant showed migration > 1 mm, but no polyethylene implant reached this level. There was a significant increase in the SF-12 and Oxford knee scores after operation in both groups. In an uncomplicated primary total knee replacement the all-polyethylene PFC-∑ tibial prosthesis showed no statistical difference in migration from that of the metal-backed counterpart. There was no difference in the clinical results as assessed by the SF-12, the Oxford knee score, alignment or range of movement at 24 months, although these assessment measures were not statistically powered in this study

Rivaroxaban has been recommended for routine use as a thromboprophylactic agent in patients undergoing lower-limb arthroplasty. However, trials supporting its use have not fully evaluated the risks of wound complications. This study of 1048 total hip/knee replacements records the rates of return to theatre and infection before and after the change from a low molecular weight heparin (tinzaparin) to rivaroxaban as the agent of chemical thromboprophylaxis in patients undergoing lower-limb arthroplasty. During a period of 13 months, 489 consecutive patients undergoing lower-limb arthroplasty received tinzaparin and the next 559 consecutive patients received rivaroxaban as thromboprophylaxis. Nine patients in the control (tinzaparin) group (1.8%, 95% confidence interval 0.9 to 3.5) returned to theatre with wound complications within 30 days, compared with 22 patients in the rivaroxaban group (3.94%, 95% confidence interval 2.6 to 5.9). This increase was statistically significant (p = 0.046). The proportion of patients who returned to theatre and became infected remained similar (p = 0.10). Our study demonstrates the need for further randomised controlled clinical trials to be conducted to assess the safety and efficacy of rivaroxaban in clinical practice, focusing on the surgical complications as well as the potential prevention of venous thromboembolism

Aims

Removal of infected components and culture-directed antibiotics are important for the successful treatment of chronic periprosthetic joint infection (PJI). However, as many as 27% of chronic PJI patients yield negative culture results. Although culture negativity has been thought of as a contraindication to one-stage revision, data supporting this assertion are limited. The aim of our study was to report on the clinical outcomes for one-stage and two-stage exchange arthroplasty performed in patients with chronic culture-negative PJI.

We performed a randomised, controlled clinical trial to compare ambulant short-course chemotherapy with anterior spinal fusion plus short-course chemotherapy for spinal tuberculosis without paraplegia. Patients with active disease of vertebral bodies were randomly allocated to one of three regimens: a) radical anterior resection with bone grafting plus six months of daily isoniazid plus rifampicin (Rad6); b) ambulant chemotherapy for six months with daily isoniazid plus rifampicin (Amb6); or c) similar to b) but with chemotherapy for nine months (Amb9). Ten years from the onset of treatment, 90% of 78 Rad6, 94% of 78 Amb6 and 99% of 79 Amb9 patients had a favourable status. Ambulant chemotherapy for a period of six months with daily isoniazid plus rifampicin (Amb6) was an effective treatment for spinal tuberculosis except in patients aged less than 15 years with an initial angle of kyphosis of more than 30° whose kyphosis increased substantially

Antibiotics are often administrated prophylactically in spinal procedures to reduce the risk of infection of the disc space. It is still not known which antibiotics are able to penetrate the intervertebral disc effectively. In a prospective, randomised, double-blind clinical study, we examined the penetration of the intervertebral discs of two commonly used antibiotics, cefuroxime and gentamicin. The patients, randomised into two groups, received either 1.5 g of cefuroxime or 5 mg/kg of gentamicin prophylactically two hours before their intervertebral discs were removed. A specimen of blood, from which serum antibiotic levels were determined, was obtained at the time of discectomy. Therapeutic levels of antibiotic were detectable in the intervertebral discs of the ten patients who received gentamicin. Only two of the ten patients (20%) who received cefuroxime had a quantifiable level of antibiotic in their discs although therapeutic serum levels of cefuroxime were found in all ten patients. Our results show that cefuroxime does not diffuse into human intervertebral discs as readily as gentamicin. It is possible that the charge due to ionisable groups on the antibiotics can influence the penetration of the antibiotics. We therefore recommend the use of gentamicin in a single prophylactic dose for all spinal procedures in order to reduce the risk of discitis

Animal studies have shown that implanted anterior cruciate ligament (ACL) grafts initially undergo a process of revascularisation prior to remodelling, ultimately increasing mechanical strength. We investigated whether minimal debridement of the intercondylar notch and the residual stump of the ruptured ACL leads to earlier revascularisation in ACL reconstruction in humans. We undertook a randomised controlled clinical trial in which 49 patients underwent ACL reconstruction using autologous four-strand hamstring tendon grafts. Randomised by the use of sealed envelopes, 25 patients had a conventional clearance of the intercondylar notch and 24 had a minimal debridement method. Three patients were excluded from the study. All patients underwent MR scanning postoperatively at 2, 6 and 12 months, together with clinical assessment using a KT-1000 arthrometer and International Knee Documentation Committee (IKDC) evaluation. All observations were made by investigators blinded to the surgical technique. Signal intensity was measured in 4 mm diameter regions of interest along the ACL graft and the mid-substance of the posterior cruciate ligament. Our results indicate that minimal debridement leads to earlier revascularisation within the mid-substance of the ACL graft at two months (paired t-test, p = 0.002). There was a significant reduction of mid-substance signal six months after the minimal debridement technique (paired t-test, p = 0.00007). No statistically significant differences were found in tunnel placement, incidence of Cyclops lesions, blood loss, IKDC scores, range of movement or Lachman test between the two groups

Aims

We compared the clinical and radiological outcomes of using a polyetheretherketone cage with (TiPEEK) and without a titanium coating (PEEK) for instrumented transforaminal lumbar interbody fusion (TLIF).

Aims

The purpose of the present study was to evaluate the impact of intravenous tranexamic acid on the reduction of blood loss, transfusion rate, and early post-operative clinical outcome in total shoulder arthroplasty.

Advances in polyethylene (PE) in total hip arthroplasty have led to interest and increased use of highly crosslinked PE (HXLPE) in total knee arthroplasty (TKA). Biomechanical data suggest improved wear characteristics for HXLPE inserts over conventional PE in TKA. Short-term results from registry data and few clinical trials are promising. Our aim is to present a review of the history of HXLPEs, the use of HXLPE inserts in TKA, concerns regarding potential mechanical complications, and a thorough review of the available biomechanical and clinical data.

Cite this article: Bone Joint J 2017;99-B:996–1002.

Objectives

Intramedullary fixation is considered the most stable treatment for pertrochanteric fractures of the proximal femur and cut-out is one of the most frequent mechanical complications. In order to determine the role of clinical variables and radiological parameters in predicting the risk of this complication, we analysed the data pertaining to a group of patients recruited over the course of six years.

Objectives

Osteoporosis has become an increasing concern for older people as it may potentially lead to osteoporotic fractures. This study is designed to assess the efficacy and safety of ten therapies for post-menopausal women using network meta-analysis.

Objectives

As tumours of bone and soft tissue are rare, multicentre prospective collaboration is essential for meaningful research and evidence-based advances in patient care. The aim of this study was to identify barriers and facilitators encountered in large-scale collaborative research by orthopaedic oncological surgeons involved or interested in prospective multicentre collaboration.

Aims

The aim of this study was to compare the effect of a percutaneous radiofrequency heat lesion at the medial branch of the primary dorsal ramus with a sham procedure, for the treatment of lumbar facet joint pain.

Aims

To compare the structural durability of hydroxyapatite-tricalcium phosphate (HATCP) to autologous iliac crest bone graft in calcaneal lengthening osteotomy (CLO) for pes planovalgus in childhood.

The August 2012 Research Roundup³⁶⁰ looks at: PRP and chondrogenic differentiation; basic fibroblast growth factor; whether glucosamine works; randomised trials; ossification of the ligamentum flavum; treadmill running; inhibiting BMP antagonists; and whether NSAIDs delay union after all.

The August 2014 Knee Roundup³⁶⁰ looks at: re-admission following total knee replacement; out with the old and in with the new? computer navigation revisited; approach less important in knee replacement; is obesity driving a rise in knee replacements?; knee replacement isn’t cheap in the obese; cruciate substitution doesn’t increase knee flexion; and sonication useful diagnostic aid in two-stage revision.

Aims

The aim of this study was to examine the efficacy and safety of multiple boluses of intravenous (IV) tranexamic acid (TXA) on the hidden blood loss (HBL) and inflammatory response following primary total hip arthroplasty (THA).

In this study, we evaluated patient-reported outcomes, the rate of revision and the indications for revision following resurfacing hemiarthroplasty of the shoulder in patients with osteoarthritis.

All patients with osteoarthritis who underwent primary resurfacing hemiarthroplasty and reported to the Danish Shoulder Arthroplasty Registry (DSR), between January 2006 and December 2010 were included. There were 772 patients (837 arthroplasties) in the study. The Western Ontario Osteoarthritis of the Shoulder (WOOS) index was used to evaluate patient-reported outcome 12 months (10 to 14) post-operatively. The rates of revision were calculated from the revisions reported to the DSR up to December 2011 and by checking deaths with the Danish National Register of Persons.

A complete questionnaire was returned by 688 patients (82.2%). The mean WOOS was 67 (0 to 100). A total of 63 hemiarthroplasties (7.5%) required revision; the cumulative five-year rate of revision was 9.9%. Patients aged < 55 years had a statistically significant inferior WOOS score, which exceeded the minimal clinically important difference, compared with older patients (mean difference 14.2 (8.8; 95% CI 19.6; p < 0.001), but with no increased risk of revision. There was no significant difference in the mean WOOS or the risk of revision between designs of resurfacing hemiarthroplasty.

Cite this article: Bone Joint J 2014;96-B:519–25.