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

We performed a double-blind, randomised controlled trial to assess the effectiveness of a continuous-infusion brachial plexus block with levobupivacaine compared with that of a standard single injection for the management of post-operative pain after surgery on the shoulder. Eight patients were randomised to receive a pre-operative brachial plexus block using 30 ml of levobupivacaine 0.5% with adrenaline 1:200 000 followed by insertion of a 20-gauge polyamide catheter. This was connected to a disposable elastometric pump, set immediately after surgery to administer a continuous flow of levobupivacaine 0.25% at a rate of 5 ml per hour. The other eight patients were randomised to receive only the initial injection of 30 ml. The study was double-blinded with the aid of sham catheters and clamped pumps. All patients were given regular paracetamol and were prescribed morphine through a patient-controlled analgesia pump. Motor and sensory block assessments, visual analogue scale pain scores and consumption of morphine were recorded after the operation and then at 6, 12 and 24 hours after administration of the block. Satisfactory motor and sensory block was achieved in all patients. The mean visual analogue scale pain score at 12 hours and consumption of morphine at 24 hours after injection were significantly lower (p < 0.05) in the continuous-infusion group. This group also took longer to request their first additional analgesia and reported a significantly higher overall level of satisfaction. Our study has shown that continuous interscalene infusion of levobupivacaine is an effective method of post-operative analgesia after major surgery of the shoulder

The aim of this study was to review the role of clinical trial networks in orthopaedic surgery. A total of two electronic databases (MEDLINE and EMBASE) were searched from inception to September 2013 with no language restrictions. Articles related to randomised controlled trials (RCTs), research networks and orthopaedic research, were identified and reviewed. The usefulness of trainee-led research collaborations is reported and our knowledge of current clinical trial infrastructure further supplements the review. Searching yielded 818 titles and abstracts, of which 12 were suitable for this review. Results are summarised and presented narratively under the following headings: 1) identifying clinically relevant research questions; 2) education and training; 3) conduct of multicentre RCTs and 4) dissemination and adoption of trial results. This review confirms growing international awareness of the important role research networks play in supporting trials in orthopaedic surgery. Multidisciplinary collaboration and adequate investment in trial infrastructure are crucial for successful delivery of RCTs. Cite this article: Bone Joint Res 2014;3:169–74

We conducted a randomised controlled trial to determine whether active intense pulsed light (IPL) is an effective treatment for patients with chronic mid-body Achilles tendinopathy. A total of 47 patients were randomly assigned to three weekly therapeutic or placebo IPL treatments. The primary outcome measure was the Victorian Institute of Sport Assessment – Achilles (VISA-A) score. Secondary outcomes were a visual analogue scale for pain (VAS) and the Lower Extremity Functional Scale (LEFS). Outcomes were recorded at baseline, six weeks and 12 weeks following treatment. Ultrasound assessment of the thickness of the tendon and neovascularisation were also recorded before and after treatment. . There was no significant difference between the groups for any of the outcome scores or ultrasound measurements by 12 weeks, showing no measurable benefit from treatment with IPL in patients with Achilles tendinopathy. Cite this article: Bone Joint J 2013;95-B:504–9

In this randomised controlled trial, we evaluated the role of elastic compression using ankle injury stockings (AIS) in the management of fractures of the ankle. A total of 90 patients with a mean age of 47 years (16 to 79) were treated within 72 hours of presentation with a fracture of the ankle, 31 of whom were treated operatively and 59 conservatively, were randomised to be treated either with compression by AIS plus an Aircast boot or Tubigrip plus an Aircast boot. Male to female ratio was 36:54. The primary outcome measure was the functional Olerud–Molander ankle score (OMAS). The secondary outcome measures were; the American Orthopaedic Foot and Ankle Society score (AOFAS); the Short Form (SF)-12v2 Quality of Life score; and the frequency of deep vein thrombosis (DVT). Compression using AIS reduced swelling of the ankle at all time points and improved the mean OMAS score at six months to 98 (95% confidence interval (CI) 96 to 99) compared with a mean of 67 (95% CI 62 to 73) for the Tubigrip group (p < 0.001). The mean AOFAS and SF-12v2 scores at six months were also significantly improved by compression. Of 86 patients with duplex imaging at four weeks, five (12%) of 43 in the AIS group and ten (23%) of 43 in the Tubigrip group developed a DVT (p = 0.26). Compression improved functional outcome and quality of life following fracture of the ankle. DVTs were frequent, but a larger study would be needed to confirm that compression with AISs reduces the incidence of DVT. . Cite this article: Bone Joint J 2014; 96-B:1062–9

We performed a prospective, randomised controlled trial of the operative versus non-operative treatment of 42 displaced fractures of the distal femur in elderly patients. Excellent or good results were achieved in 53% of the operated group and in 31% of the non-operated group. There were more complications in the latter, and the time to discharge was considerably longer

We hypothesised that the removal of the subchondral bone plate (SCBP) for cemented acetabular component fixation in total hip arthroplasty (THA) offers advantages over retention by improving the cement-bone interface, without jeopardising implant stability. We have previously published two-year follow-up data of a randomised controlled trial (RCT), in which 50 patients with primary osteoarthritis were randomised to either retention or removal of the SCBP. The mean age of the retention group (n = 25, 13 males) was 70.0 years (. sd. 6.8). The mean age in the removal group (n = 25, 16 males) was 70.3 years (. sd. 7.9). Now we have followed up the patients at six (retention group, n = 21; removal group, n = 20) and ten years (retention group: n = 17, removal group: n = 18), administering clinical outcome questionnaires and radiostereometric analysis (RSA), and determining the presence of radiolucent lines (RLLs) on conventional radiographs. RSA demonstrated similar translation and rotation patterns up to six years. Between six and ten years, proximal acetabular component migration and changes of inclination were larger in the retention group, although the mean differences did not reach statistical significance. Differences in migration were driven by two patients in the SCBP retention group with extensive migration versus none in the SCBP removal group. The significant difference (p < 0.001) in the development of radiolucent lines in the retention group, previously observed at two years, increased even further during the course of follow-up (p < 0.001). While recognising SCBP removal is a more demanding technique, we conclude that, wherever possible, the SCBP should be removed to improve the cement–bone interface in order to maximise acetabular component stability and longevity. Cite this article: Bone Joint J 2015;97-B:35–44

In a prospective, randomised controlled trial, the efficacy of the A-V Impulse System in the prevention of deep-vein thrombosis was investigated in 84 patients who had undergone total hip replacement. The incidence of venographically proven, and clinically significant postoperative deep-vein thrombosis was 40% in the control group and 5% in the treatment group (p less than 0.001). No adverse reactions were recorded

We undertook a randomised controlled trial to compare bipolar hemiarthroplasty (HA) with a novel total hip replacement (THR) comprising a polycarbonate–urethane (PCU) acetabular component coupled with a large-diameter metal femoral head for the treatment of displaced fractures of the femoral neck in elderly patients. Functional outcome, assessed with the Harris hip score (HHS) at three months and then annually after surgery, was the primary endpoint. Rates of revision and complication were secondary endpoints. Based on a power analysis, 96 consecutive patients aged > 70 years were randomised to receive either HA (49) or a PCU-THR (47). The mean follow-up was 30.1 months (23 to 50) and 28.6 months (22 to 52) for the HA and the PCU group, respectively. The HHS showed no statistically significant difference between the groups at every follow-up. Higher pain was recorded in the PCU group at one and two years’ follow-up (p = 0.006 and p = 0.019, respectively). In the HA group no revision was performed. In the PCU-THR group six patients underwent revision and one patient is currently awaiting re-operation. The three-year survival rate of the PCU-THR group was 0.841 (95% confidence interval 0.680 to 0.926). Based on our findings we do not recommend the use of the PCU acetabular component as part of the treatment of patients with fractures of the femoral neck. Cite this article: Bone Joint J 2013;95-B:609–15

The osteoinductive properties of demineralised bone matrix have been demonstrated in animal studies. However, its therapeutic efficacy has yet to be proven in humans. The clinical properties of AlloMatrix, an injectable calcium-based demineralised bone matrix allograft, were studied in a prospective randomised study of 50 patients with an isolated unstable distal radial fracture treated by reduction and Kirschner (K-) wire fixation. A total of 24 patients were randomised to the graft group (13 men and 11 women, mean age 42.3 years (20 to 62)) and 26 to the no graft group (8 men and 18 women, mean age 45.0 years (17 to 69)). At one, three, six and nine weeks, and six and 12 months post-operatively, patients underwent radiological evaluation, assessments for range of movement, grip and pinch strength, and also completed the Disabilities of Arm, Shoulder and Hand questionnaire. At one and six weeks and one year post-operatively, bone mineral density evaluations of both wrists were performed. No significant difference in wrist function and speed of recovery, rate of union, complications or bone mineral density was found between the two groups. The operating time was significantly higher in the graft group (p = 0.004). Radiologically, the reduction parameters remained similar in the two groups and all AlloMatrix extraosseous leakages disappeared after nine weeks. This prospective randomised controlled trial did not demonstrate a beneficial effect of AlloMatrix demineralised bone matrix in the treatment of this category of distal radial fractures treated by K-wire fixation. Cite this article: Bone Joint J 2013;95-B:1514–20

The ideal bearing surface for young patients undergoing total hip replacement (THR) remains controversial. We report the five-year results of a randomised controlled trial comparing the clinical and radiological outcomes of 102 THRs in 91 patients who were <  65 years of age. These patients were randomised to receive a cobalt–chrome on ultra-high-molecular-weight polyethylene, cobalt–chrome on highly cross-linked polyethylene, or a ceramic-on-ceramic bearing. In all, 97 hip replacements in 87 patients were available for review at five years. Two hips had been revised, one for infection and one for peri-prosthetic fracture. At the final follow-up there were no significant differences between the groups for the mean Western Ontario and McMaster Universities osteoarthritis index (pain, p = 0.543; function, p = 0.10; stiffness, p = 0.99), Short Form-12 (physical component, p = 0.878; mental component, p = 0.818) or Harris hip scores (p = 0.22). Radiological outcomes revealed no significant wear in the ceramic group. Comparison of standard and highly cross-linked polyethylene, however, revealed an almost threefold difference in the mean annual linear wear rates (0.151 mm/year versus 0.059 mm/year, respectively) (p < 0.001)

We have carried out a randomised, controlled trial on 70 patients having unilateral total knee replacement in which transfusion was either with homologous bank blood or by reinfusion of unwashed blood salvaged after operation. No complications or adverse effects were observed from reinfusion. The need for bank blood was reduced by 86% in the reinfusion group but, more importantly, the number of infective episodes was significantly less when the use of bank blood was avoided. The mean length of stay in hospital was also reduced by more than two days

We performed a systematic review and meta-analysis to compare the efficacy of intermittent mechanical compression combined with pharmacological thromboprophylaxis, against either mechanical compression or pharmacological prophylaxis in preventing deep-vein thrombosis (DVT) and pulmonary embolism in patients undergoing hip or knee replacement. A total of six randomised controlled trials, evaluating a total of 1399 patients, were identified. In knee arthroplasty, the rate of DVT was reduced from 18.7% with anticoagulation alone to 3.7% with combined modalities (risk ratio (RR) 0.27, p = 0.03; number needed to treat: seven). There was moderate, albeit non-significant, heterogeneity (I. 2. = 42%). In hip replacement, there was a non-significant reduction in DVT from 8.7% with mechanical compression alone to 7.2% with additional pharmacological prophylaxis (RR 0.84) and a significant reduction in DVT from 9.7% with anticoagulation alone to 0.9% with additional mechanical compression (RR 0.17, p < 0.001; number needed to treat: 12), with no heterogeneity (I. 2. = 0%). The included studies had insufficient power to demonstrate an effect on pulmonary embolism. We conclude that the addition of intermittent mechanical leg compression augments the efficacy of anticoagulation in preventing DVT in patients undergoing both knee and hip replacement. Further research on the role of combined modalities in thromboprophylaxis in joint replacement and in other high-risk situations, such as fracture of the hip, is warranted

We report a prospective, randomised, controlled trial of 50 severely displaced comminuted Colles' fractures treated by either external fixation or manipulation and plaster. Each patient was assessed radiographically throughout treatment, and functionally by an independent observer at three and six months. The functional result correlated with the anatomical result, which was significantly better in patients treated by external fixation. This resulted in significantly improved function especially in young patients, and also a lower complication rate. We recommend the use of external fixation for young patients with comminuted displaced Colles' fractures unless manipulation and plaster show excellent reduction

We carried out a blinded prospective randomised controlled trial comparing 2-octylcyanoacrylate (OCA), subcuticular suture (monocryl) and skin staples for skin closure following total hip and total knee arthroplasty. We included 102 hip replacements and 85 of the knee. OCA was associated with less wound discharge in the first 24 hours for both the hip and the knee. However, with total knee replacement there was a trend for a more prolonged wound discharge with OCA. With total hip replacement there was no significant difference between the groups for either early or late complications. Closure of the wound with skin staples was significantly faster than with OCA or suture. There was no significant difference in the length of stay in hospital, Hollander wound evaluation score (cosmesis) or patient satisfaction between the groups at six weeks for either hips or knees. We consider that skin staples are the skin closure of choice for both hip and knee replacements

We reviewed systematically the published evidence on the effectiveness of antibiotic prophylaxis for the reduction of wound infection in patients undergoing total hip and total knee replacement. Publications were identified using the Cochrane Library, MEDLINE, EMBASE and CINAHL databases. We also contacted authors to identify unpublished trials. We included randomised controlled trials which compared any prophylaxis with none, the administration of systemic antibiotics with that of those in cement, cephalosporins with glycopeptides, cephalosporins with penicillin-derivatives, and second-generation with first-generation cephalosporins. A total of 26 studies (11 343 participants) met the inclusion criteria. Methodological quality was variable. In a meta-analysis of seven studies (3065 participants) antibiotic prophylaxis reduced the absolute risk of wound infection by 8% and the relative risk by 81% compared with no prophylaxis (p < 0.00001). No other comparison showed a significant difference in clinical effect. Antibiotic prophylaxis should be routine in joint replacement but the choice of agent should be made on the basis of cost and local availability

Prophylaxis against venous thromboembolism after elective total hip replacement is routinely recommended. Our preference has been to use mechanical prophylaxis without anticoagulant drugs. A randomised controlled trial was performed to evaluate whether the incidence of post-operative venous thromboembolism was reduced by using pharmacological anticoagulation with either fondaparinux or enoxaparin in addition to our prophylactic mechanical regimen. A total of 255 Japanese patients who underwent primary unilateral cementless total hip replacement were randomly assigned to one of three postoperative regimens, namely injection of placebo (saline), fondaparinux or enoxaparin. There were 85 patients in each group. All also received the same mechanical prophylaxis during and after the operation, regardless of their assigned group. The primary measurement of efficacy was the presence of a venous thromboembolic event by day 11, defined as deep-vein thrombosis detected by ultrasonography, documented symptomatic deep-vein thrombosis or documented symptomatic pulmonary embolism. The duration of follow-up was 12 weeks. The rate of venous thromboembolism was 7.2% with the placebo, 7.1% with fondaparinux and 6.0% with enoxaparin (p = 0.95 for the comparison of all three groups). Our study confirmed the effectiveness and safety of mechanical thromboprophylaxis without the use of anticoagulant drugs after total hip replacement in Japanese patients

We performed a randomised controlled trial comparing computer-assisted surgery (CAS) with conventional surgery (CONV) in total knee replacement (TKR). Between 2009 and 2011 a total of 192 patients with a mean age of 68 years (55 to 85) with osteoarthritis or arthritic disease of the knee were recruited from four Norwegian hospitals. At three months follow-up, functional results were marginally better for the CAS group. Mean differences (MD) in favour of CAS were found for the Knee Society function score (MD: 5.9, 95% confidence interval (CI) 0.3 to 11.4, p = 0.039), the Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales for ‘pain’ (MD: 7.7, 95% CI 1.7 to 13.6, p = 0.012), ‘sports’ (MD: 13.5, 95% CI 5.6 to 21.4, p = 0.001) and ‘quality of life’ (MD: 7.2, 95% CI 0.1 to 14.3, p = 0.046). At one-year follow-up, differences favouring CAS were found for KOOS ‘sports’ (MD: 11.0, 95% CI 3.0 to 19.0, p = 0.007) and KOOS ‘symptoms’ (MD: 6.7, 95% CI 0.5 to 13.0, p = 0.035). The use of CAS resulted in fewer outliers in frontal alignment (> 3° malalignment), both for the entire TKR (37.9% vs 17.9%, p = 0.042) and for the tibial component separately (28.4% vs 6.3%, p = 0.002). Tibial slope was better achieved with CAS (58.9% vs 26.3%, p < 0.001). Operation time was 20 minutes longer with CAS. In conclusion, functional results were, statistically, marginally in favour of CAS. Also, CAS was more predictable than CONV for mechanical alignment and positioning of the prosthesis. However, the long-term outcomes must be further investigated. Cite this article: Bone Joint J 2014; 96-B:609–18

Modifications in the design of knee replacements have been proposed in order to maximise flexion. We performed a prospective double-blind randomised controlled trial to compare the functional outcome, including maximum knee flexion, in patients receiving either a standard or a high flexion version of the NexGen legacy posterior stabilised total knee replacement. A total of 56 patients, half of whom received each design, were assessed pre-operatively and at one year after operation using knee scores and analysis of range of movement using electrogoniometry. For both implant designs there was a significant improvement in the function component of the knee scores (p < 0.001) and the maximum range of flexion when walking on the level, ascending and descending a slope or stairs (all p < 0.001), squatting (p = 0.020) and stepping into a bath (p = 0.024). There was no significant difference in outcome, including the maximum knee flexion, between patients receiving the standard and high flexion designs of this implant