Amin A, Watson A, Mangwani J, Nawabi DH, Ahluwalia R, Loeffler M. A prospective randomised controlled trial of autologous retransfusion in total knee replacement. Bone Joint J 2008;90-B:451–454

We have assessed whether an epidural steroid injection is effective in the treatment of symptoms due to compression of a nerve root in the lumbar spine by carrying out a prospective, randomised, controlled trial in which patients received either an epidural steroid injection or an intramuscular injection of local anaesthetic and steroid. We assessed a total of 93 patients according to the Oxford pain chart and the Oswestry disability index and followed up for a minimum of two years. All the patients had been categorised as potential candidates for surgery. There was a significant reduction in pain early on in those having an epidural steroid injection but no difference in the long term between the two groups. The rate of subsequent operation in the groups was similar

We undertook a randomised controlled trial to compare the piriformis-sparing approach with the standard posterior approach used for total hip replacement (THR). We recruited 100 patients awaiting THR and randomly allocated them to either the piriformis-sparing approach or the standard posterior approach. Pre- and post-operative care programmes and rehabilitation regimes were identical for both groups. Observers were blinded to the allocation throughout; patients were blinded until the two-week assessment. Follow-up was at six weeks, three months, one year and two years. In all 11 patients died or were lost to follow-up. There was no significant difference between groups for any of the functional outcomes. However, for patients in the piriformis-sparing group there was a trend towards a better six-minute walk test at two weeks and greater patient satisfaction at six weeks. The acetabular components were less anteverted (p = 0.005) and had a lower mean inclination angle (p = 0.02) in the piriformis-sparing group. However, in both groups the mean component positions were within Lewinnek’s safe zone. Surgeons perceived the piriformis-sparing approach to be significantly more difficult than the standard approach (p = 0.03), particularly in obese patients. . In conclusion, performing THR through a shorter incision involving sparing piriformis is more difficult and only provides short-term benefits compared with the standard posterior approach

The anatomy and microstructure of the menisci allow the effective distribution of load across the knee. Meniscectomy alters the biomechanical environment and is a potent risk factor for osteoarthritis. Despite a trend towards meniscus-preserving surgery, many tears are irreparable, and many repairs fail. . Meniscal allograft transplantation has principally been carried out for pain in patients who have had a meniscectomy. Numerous case series have reported a significant improvement in patient-reported outcomes after surgery, but randomised controlled trials have not been undertaken. It is scientifically plausible that meniscal allograft transplantation is protective of cartilage, but this has not been established clinically to date. Cite this article: Bone Joint J 2015; 97-B:590–4

Aims. Multimodal infiltration of local anaesthetic provides effective control of pain in patients undergoing total knee arthroplasty (TKA). There is little information about the added benefits of posterior capsular infiltration (PCI) using different combinations of local anaesthetic agents. Our aim was to investigate the effectiveness of the control of pain using multimodal infiltration with and without infiltration of the posterior capsule of the knee. Patients and Methods. In a double-blind, randomised controlled trial of patients scheduled for unilateral primary TKA, 86 were assigned to be treated with multimodal infiltration with (Group I) or without (Group II) PCI. Routine associated analgesia included the use of bupivacaine, morphine, ketorolac and epinephrine. All patients had spinal anaesthesia and patient-controlled analgesia (PCA) post-operatively. A visual analogue scale (VAS) for pain and the use of morphine were recorded 24 hours post-operatively. Side effects of the infiltration, blood loss, and length of stay in hospital were recorded. Results. There were no statistically significant differences between the groups in relation to: VAS pain scores in the first 24 hours post-operatively (p = 0.693), the use of morphine in the PCA (p = 0.647), blood loss (p = 0.625), and length of stay (p = 0.17). There were no neurovascular complications in either group. Conclusion. The multimodal infiltration of local anaesthetic with infiltration of the posterior capsule did not provide significant added analgesic benefits or reduce the use of morphine after TKA. Multimodal infiltration is a satisfactory technique for the management of pain in these patients without the attendant risks of PCI. Cite this article: Bone Joint J 2017; 99-B:483–8

Aims. Our aim was to prepare a systematic review and meta-analysis to compare the outcomes of cemented and cementless hemiarthroplasty of the hip, in elderly patients with a fracture of the femoral neck, to investigate the mortality, complications, length of stay in hospital, blood loss, operating time and functional results. Materials and Methods. A systematic review and meta-analysis was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines on randomised controlled trials (RCTs), studying current generation designs of stem only. The synthesis of results was done of pooled data, with a fixed effects or random effects model, based on heterogeneity. Results. A total of five RCTs including 950 patients (950 hips) were included. Cementless stems were found to be associated with more complications compared with cemented stems (odds ratio (OR) 1.61, 95% confidence interval (CI) 1.12 to 2.31, p = 0.01), especially implant-related complications (OR 3.15, 95% CI 1.55 to 6.41, p = 0.002). The operating time was shorter for cementless stems (weighted mean difference -9.96 mins, 95%CI -12.93 to -6.98, p < 0.001). The data on functional outcomes could not be pooled. There was no statistically significant difference for any other outcome between the two methods of fixation. Conclusion. In hemiarthroplasty of the hip using current generation stems, cemented stems result in fewer implant-related complications and similar mortality compared with cementless stems. Cite this article: Bone Joint J 2017;99-B:421–31

We performed a systematic review and meta-analysis of modern total ankle replacements (TARs) to determine the survivorship, outcome, complications, radiological findings and range of movement, in patients with end-stage osteoarthritis (OA) of the ankle who undergo this procedure. We used the methodology of the Cochrane Collaboration, which uses risk of bias profiling to assess the quality of papers in favour of a domain-based approach. Continuous outcome scores were pooled across studies using the generic inverse variance method and the random-effects model was used to incorporate clinical and methodological heterogeneity. We included 58 papers (7942 TARs) with an interobserver reliability (Kappa) for selection, performance, attrition, detection and reporting bias of between 0.83 and 0.98. The overall survivorship was 89% at ten years with an annual failure rate of 1.2% (95% confidence interval (CI) 0.7 to 1.6). The mean American Orthopaedic Foot and Ankle Society score changed from 40 (95% CI 36 to 43) pre-operatively to 80 (95% CI 76 to 84) at a mean follow-up of 8.2 years (7 to 10) (p < 0.01). Radiolucencies were identified in up to 23% of TARs after a mean of 4.4 years (2.3 to 9.6). The mean total range of movement improved from 23° (95% CI 19 to 26) to 34° (95% CI 26 to 41) (p = 0.01). Our study demonstrates that TAR has a positive impact on patients’ lives, with benefits lasting ten years, as judged by improvement in pain and function, as well as improved gait and increased range of movement. However, the quality of evidence is weak and fraught with biases and high quality randomised controlled trials are required to compare TAR with other forms of treatment such as fusion. Cite this article: Bone Joint J 2013;95-B:1500–7

We performed two independent, randomised, controlled trials in order to assess the potential benefits of immediate weight-bearing mobilisation after rupture of the tendo Achillis. The first trial, on operatively-treated patients showed an improved functional outcome for patients mobilised fully weight-bearing after surgical repair. Two cases of re-rupture in the treatment group suggested that careful patient selection is required as patients need to follow a structured rehabilitation regimen. The second trial, on conservatively-treated patients, provided no evidence of a functional benefit from immediate weight-bearing mobilisation. However, the practical advantages of immediate weight-bearing did not predispose the patients to a higher complication rate. In particular, there was no evidence of tendon lengthening or a higher re-rupture rate. We would advocate immediate weight-bearing mobilisation for the rehabilitation of all patients with rupture of the tendo Achillis

Cadossi M, Chiarello E, Savarino L, Tedesco G, Baldini N, Faldini C, Giannini S. A comparison of hemiarthroplasty with a novel polycarbonate-urethane acetabular component for displaced intracapsular fractures of the femoral neck: a randomised controlled trial in elderly patients. Bone Joint J 2013;95-B:609-615

Bicruciate-stabilised total knee replacement (TKR) aims to restore normal kinematics by replicating the function of both cruciate ligaments. We performed a prospective, randomised controlled trial in which bicruciate- and posterior-stabilised TKRs were implanted in 13 and 15 osteo-arthritic knees, respectively. The mean age of the bicruciate-stabilised group was 63.9 years (. sd. 10.00) and that of the posterior-stabilised group 63.2 years (. sd. 6.7). A control group comprised 14 normal subjects with a mean age of 67.9 years (. sd. 7.9). The patellar tendon angle (PTA) was measured one week pre-operatively and at seven weeks post-operatively during knee extension, flexion and step-up exercises. At near full extension during step-up, the bicruciate-stabilised TKR produced a higher mean PTA than the posterior-stabilised TKR, indicating that the bicruciate design at least partially restored the kinematic role of the anterior cruciate ligament. The bicruciate-stabilised TKR largely restored the pre-operative kinematics, whereas the posterior-stabilised TKR resulted in a consistently lower PTA at all activities. The PTA in the pre-operative knees was higher than in the control group during the step-up and at near full knee extension. Overall, both groups generated a more normal PTA than that seen in previous studies in high knee flexion. This suggested that both designs of TKR were more effective at replicating the kinematic role of the posterior cruciate ligament than those used in previous studies

A prospective, randomised, controlled trial compared two different techniques of high tibial osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu plate. The clinical outcome and radiological results were examined at one year. The primary outcome measure was the achievement of an overcorrection of valgus of 4°. Secondary outcome measures were the severity of pain (visual analogue scale), knee function (Hospital for Special Surgery score), and walking distance. Between January 2001 and April 2004, 92 patients were randomised to one or other of the techniques. At follow-up at one year the post-operative hip-knee-ankle angle was 3.4° (± 3.6° . sd. ) valgus after a closing wedge and 1.3° (± 4.7° . sd. ) of valgus after an opening wedge. The adjusted mean difference of 2.1° was significant (p = 0.02). The deviation from 4° of valgus alignment was 2.7° (± 2.4° . sd. ) in the closing wedge and 4.0° (± 3.6° . sd. ) in the opening-wedge groups. The adjusted mean difference of 1.67° was also significant (p = 0.01). The severity of pain, knee score and walking ability improved in both groups, but the difference was not significant. Because of pain, the staples required removal in 11 (23%) patients in the closing-wedge group and a Puddu plate was removed in 27 (60%) patients in the opening-wedge group. This difference was significant (p < 0.001). We conclude that closing-wedge osteotomy achieves a more accurate correction with less morbidity, although both techniques had improved the function of the knee at one year after the procedure

We report a randomised controlled trial to examine the effectiveness and cost-effectiveness of arthroscopic acromioplasty in the treatment of stage II shoulder impingement syndrome. A total of 140 patients were randomly divided into two treatment groups: supervised exercise programme (n = 70, exercise group) and arthroscopic acromioplasty followed by a similar exercise programme (n = 70, combined treatment group). The main outcome measure was self-reported pain on a visual analogue scale of 0 to 10 at 24 months, measured on the 134 patients (66 in the exercise group and 68 in the combined treatment group) for whom endpoint data were available. An intention-to-treat analysis disclosed an improvement in both groups but without statistically significant difference in outcome between the groups (p = 0.65). The combined treatment was considerably more costly. Arthroscopic acromioplasty provides no clinically important effects over a structured and supervised exercise programme alone in terms of subjective outcome or cost-effectiveness when measured at 24 months. Structured exercise treatment should be the basis for treatment of shoulder impingement syndrome, with operative treatment offered judiciously until its true merit is proven

We performed a prospective, randomised controlled trial of unicompartmental knee arthroplasty comparing the performance of the Acrobot system with conventional surgery. A total of 27 patients (28 knees) awaiting unicompartmental knee arthroplasty were randomly allocated to have the operation performed conventionally or with the assistance of the Acrobot. The primary outcome measurement was the angle of tibiofemoral alignment in the coronal plane, measured by CT. Other secondary parameters were evaluated and are reported. All of the Acrobot group had tibiofemoral alignment in the coronal plane within 2° of the planned position, while only 40% of the conventional group achieved this level of accuracy. While the operations took longer, no adverse effects were noted, and there was a trend towards improvement in performance with increasing accuracy based on the Western Ontario and McMaster Universities Osteoarthritis Index and American Knee Society scores at six weeks and three months. The Acrobot device allows the surgeon to reproduce a pre-operative plan more reliably than is possible using conventional techniques which may have clinical advantages

We conducted a randomised controlled trial to compare external fixation of trochanteric fractures of the femur with the more costly option of the sliding hip screw. Patients in both groups were matched for age (mean 67 years, 50 to 100) and gender. We excluded all pathological fractures, patients presenting at more than one week, fractures with subtrochanteric extension or reverse obliquity, multiple fractures or any bone and joint disease interfering with rehabilitation. The interval between injury and operation, the duration of surgery, the amount of blood loss, the length of hospital stay and the cost of treatment were all significantly higher in the sliding hip screw group (p < 0.05). The time to union, range of movement, mean Harris hip scores and Western Ontario and McMaster University knee scores were comparable at six months. The number of patients showing shortening or malrotation was too small to show a significant difference between the groups. Pin-track infection occurred in 18 patients (60%) treated with external fixation, whereas there was a single case of wound infection (3.3%) in the sliding hip screw group

Aims. There is uncertainty regarding the optimal means of thromboprophylaxis following total hip and knee arthroplasty (THA, TKA). This systematic review presents the evidence for acetylsalicylic acid (aspirin) as a thromboprophylactic agent in THA and TKA and compares it with other chemoprophylactic agents. Materials and Methods. A search of literature published between 2004 and 2014 was performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A total of 13 studies were eligible for inclusion. Results. Evidence from one good quality randomised controlled trial (RCT) showed no difference in rates of venous thrombo-embolism (VTE) in patients given aspirin or low molecular weight heparin (LMWH) following TKA. There was insufficient evidence from trials with moderate to severe risk of bias being present to suggest aspirin is more or less effective than LMWH, warfarin or dabigatran for the prevention of VTE in TKA or THA. Compared with aspirin, rates of asymptomatic deep vein thrombosis (DVT) in TKA may be reduced with rivaroxaban but insufficient evidence exists to demonstrate an effect on incidence of symptomatic DVT. Compared with aspirin there is evidence of more wound complications following THA and TKA with dabigatran and in TKA with rivaroxaban. Some studies highlighted concerns over bleeding complications and efficacy of aspirin. Conclusion. The results suggest aspirin may be considered a suitable alternative to other thromboprophylactic agents following THA and TKA. Further investigation is required to fully evaluate the safety and efficacy of aspirin. Cite this article: Bone Joint J 2016;98-B:1056–61

We compared the safety and outcome of one-stage bilateral total hip arthroplasty with those of a two-stage procedure during different admissions in a prospective, randomised controlled trial in an Asian population. Of 168 patients included in the study, 83 had a single- and 85 a two-stage procedure. Most of the patients (59.9%) suffered from inflammatory arthritis. The intra-operative complications, early systemic complications, the operating time, positioning of the components, the functional score, restoration of limb length and survival rates at 96 months were similar in the two groups. The total estimated blood loss was significantly lower in patients undergoing a one-stage procedure than in patients who had a two-stage procedure, but the transfusion requirements were significantly higher in the former group (p = 0.001). The hospital stay was significantly shorter in the one-stage group, 7.25 days (. sd. 1.30; 5 to 20) compared with 10 days (. sd. 1.65; 8 to 24) in the two-stage group (p = 0.023). We believe that a one-stage procedure is safe and appropriate in our population

We have evaluated the difference in the migration patterns over two years of two cementless stems in a randomised, controlled trial using radiostereophotogrammetric analysis (RSA). The implants studied were the Furlong HAC stem, which has good long-term results and the Furlong Active stem, which is a modified version of the former designed to minimise stress concentrations between the implant and bone, and thus to improve fixation. A total of 23 Furlong HAC and 20 Furlong Active stems were implanted in 43 patients. RSA examinations were carried out immediately post-operatively and at six, 12 and 24 months post-operatively. The subsidence during the first year in the Furlong HAC stem, was approximately one-third that of the Furlong Active stem, the measured mean subsidence of the femoral head at six months being 0.27 mm (95% confidence interval (CI) 0.03 to 0.51) and 0.99 mm (95% CI 0.38 to 1.60), respectively (p = 0.03). One Active stem continued to subside during the second year. All hips, regardless of the type of stem were clinically successful as judged by the Oxford hip score and a derived pain score without any distinction between the two types of stem. The initial stability of the Furlong Active stem was not as good as the established stem which might compromise osseo-integration to the detriment of long-term success. The changes in the geometry of the stem, to minimise stress have affected the attainment of initial stability

Aims. The role of high tibial osteotomy (HTO) is being questioned by the use of unicompartmental knee arthroplasty (UKA) in the treatment of medial compartment femorotibial osteoarthritis. Our aim was to compare the outcomes of revision HTO or UKA to a total knee arthroplasty (TKA) using computer-assisted surgery in matched groups of patients. Patients and Methods. We conducted a retrospective study to compare the clinical and radiological outcome of patients who underwent revision of a HTO to a TKA (group 1) with those who underwent revision of a medial UKA to a TKA (group 2). All revision procedures were performed using computer-assisted surgery. We extracted these groups of patients from our database. They were matched by age, gender, body mass index, follow-up and pre-operative functional score. The outcomes included the Knee Society Scores (KSS), radiological outcomes and the rate of further revision. Results. There were 20 knees in 20 patients in each group. The mean follow-up was 4.1 years (2 to 18.7). The mean total KSS at last follow-up was 185.7 (standard deviation (. sd. ) 5) in group 1 compared with 176.5 (. sd. 11) for group 2 (p = 0.003). The mean hip-knee-ankle angle was 180.2° (. sd. 3.2°) in group 1 and 179.0° (. sd. 2.2°) in group 2. No revision was required. Conclusion. We found that good functional and radiological outcomes followed revision of both HTO and UKA to TKA. Revision of HTO showed significantly better functional outcomes. These results need to be further investigated by a prospective randomised controlled trial involving a larger group of patients. Cite this article: Bone Joint J 2016;98-B:1620–4

Aims. This prospective randomised controlled trial was designed to evaluate the outcome of both the MRI- and CT-based patient-specific matched guides (PSG) from the same manufacturer. Patients and Methods. A total of 137 knees in 137 patients (50 men, 87 women) were included, 67 in the MRI- and 70 in the CT-based PSG group. Their mean age was 68.4 years (47.0 to 88.9). Outcome was expressed as the biomechanical limb alignment (centre hip-knee-ankle: HKA-axis) achieved post-operatively, the position of the individual components within 3° of the pre-operatively planned alignment, correct planned implant size and operative data (e.g. operating time and blood loss). Results. The patient demographics (e.g. age, body mass index), correct planned implant size and operative data were not significantly different between the two groups. The proportion of outliers in the coronal and sagittal plane ranged from 0% to 21% in both groups. Only the number of outliers for the posterior slope of the tibial component showed a significant difference (p = 0.004) with more outliers in the CT group (n = 9, 13%) than in the MRI group (0%). . Conclusion. The post-operative HKA-axis was comparable in the MRI- and CT-based PSGs, but there were significantly more outliers for the posterior slope in the CT-based PSGs. Take home message: Alignment with MRI-based PSG is at least as good as, if not better, than that of the CT-based PSG, and is the preferred imaging modality when performing TKA with use of PSG. Cite this article: Bone Joint J 2016;98-B:786–92

High-quality randomised controlled trials (RCTs) evaluating surgical therapies are fundamental to the delivery of evidence-based orthopaedics. Orthopaedic clinical trials have unique challenges; however, when these challenges are overcome, evidence from trials can be definitive in its impact on surgical practice. In this review, we highlight several issues that pose potential challenges to orthopaedic investigators aiming to perform surgical randomised controlled trials. We begin with a discussion on trial design issues, including the ethics of sham surgery, the importance of sample size, the need for patient-important outcomes, and overcoming expertise bias. We then explore features surrounding the execution of surgical randomised trials, including ethics review boards, the importance of organisational frameworks, and obtaining adequate funding. Cite this article: Bone Joint Res 2014;3:161–8