We have performed a prospective double-blind, randomised controlled trial over two years to evaluate the efficacy and safety of an intra-operative peri-articular injection of triamcinolone acetonide in patients undergoing medial unicondylar knee replacement. We randomised 90 patients into two equal groups. The study group received an injection of triamcinolone acetonide, bupivacaine, and epinephrine into the peri-articular tissues at the end of the operation. The control group received the same injection mixture but without the addition of triamcinolone. The peri-operative analgesic regimen was standardised. The study group reported a significant reduction in pain (p = 0.014 at 12 hours, p = 0.031 at 18 hours and p = 0.031 at 24 hours) and had a better range of movement (p = 0.023 at three months). There was no significant difference in the rate of infection and no incidence of tendon rupture in either group. The addition of corticosteroid to the peri-articular injection after unicondylar knee replacement had both immediate and short-term benefits in terms of relief from pain, and rehabilitation with no increased risk of infection

We performed a prospective randomised controlled trial of the A-V Impulse System in 82 patients treated by hemiarthroplasty for subcapital fracture of the femoral neck. The incidence of proximal deep-vein thrombosis as assessed by Doppler ultrasonography was 23% in the control group and 0% in those using the device (p less than 0.01). Calf and thigh circumferences were measured in both groups at seven to ten days after operation. In the treatment group there was a mean relative reduction of postoperative swelling of the thigh by 3.27 cm (p less than 0.001) and of the calf by 1.55 cm (p less than 0.001). The A-V Impulse System appears to be a safe and effective method of reducing the incidence of proximal deep-vein thrombosis, and of postoperative swelling

We report the results of a prospective randomised controlled trial of the management of 101 Colles' fractures in patients over the age of 55 years. Within two weeks of initial reduction 43 fractures had displaced with either more than 10 degrees dorsal angulation or more than 5 mm radial shortening. These patients were randomly divided into two groups: 21 were remanipulated and held by an external fixator; in the control group of 22 patients, the redisplacement was accepted and conservative treatment was continued. Patients treated with external fixation had a good anatomical result, but their function was no better than that of the control group. We found no correlation between final anatomical and functional outcome, and concluded that the severity of the original soft-tissue injury and its complications are the major determinants of functional end result

We conducted a randomised, controlled trial to determine whether changing gloves at specified intervals can reduce the incidence of glove perforation and contamination in total hip arthroplasty. A total of 50 patients were included in the study. In the study group (25 patients), gloves were changed at 20-minute intervals or prior to cementation. In the control group (25 patients), gloves were changed prior to cementation. In addition, gloves were changed in both groups whenever there was a visible puncture. Only outer gloves were investigated. Contamination was tested by impression of gloved fingers on blood agar and culture plates were subsequently incubated at 37°C for 48 hours. The number of colonies and types of organisms were recorded. Glove perforation was assessed using the water test. The incidence of perforation and contamination was significantly lower in the study group compared with the control group. Changing gloves at regular intervals is an effective way to decrease the incidence of glove perforation and bacterial contamination during total hip arthroplasty

We conducted a systematic review and meta-analysis of randomised controlled trials evaluating the effect of tranexamic acid (TXA) upon blood loss and transfusion in primary total knee replacement. The review used the generic evaluation tool designed by the Cochrane Bone, Joint and Muscle Trauma Group. A total of 19 trials were eligible: 18 used intravenous administration, one also evaluated oral dosing and one trial evaluated topical use. TXA led to a significant reduction in the proportion of patients requiring blood transfusion (risk ratio (RR) 2.56, 95% confidence interval (CI) 2.1 to 3.1, p < 0.001; heterogeneity I. 2. = 75%; 14 trials, 824 patients). Using TXA also reduced total blood loss by a mean of 591 ml (95% CI 536 to 647, p < 0.001; I. 2. = 78%; nine trials, 763 patients). The clinical interpretation of these findings is limited by substantial heterogeneity. However, subgroup analysis of high-dose (> 4 g) TXA showed a plausible consistent reduction in blood transfusion requirements (RR 5.33; 95% CI 2.44 to 11.65, p < 0.001; I. 2. = 0%), a finding that should be confirmed by a further well-designed trial. The current evidence from trials does not support an increased risk of deep-vein thrombosis (13 trials, 801 patients) or pulmonary embolism (18 trials, 971 patients) due to TXA administration

We conducted a prospective, randomised, controlled trial of 45 patients (47 elbows), with tennis elbow, who underwent either a formal open release or a percutaneous tenotomy. All patients had pre- and post-operative assessment using the Disability of Arm, Shoulder and Hand (DASH) scoring system. Both groups were followed up for a minimum of 12 months. Statistical analyses using the Mann-Whitney U test and repeated measured ANOVA showed significant improvements for patient satisfaction (p = 0.012), time to return to work (p = 0.0001), improvements in DASH score (p = 0.001) and improvement in sporting activities (p = 0.046) in the percutaneous group. Those patients undergoing a percutaneous release returned to work on average three weeks earlier and improved significantly more quickly than those undergoing an open procedure. The percutaneous procedure is a quicker and simpler procedure to undertake and produces significantly better results

We performed a randomised, controlled trial involving 150 patients with a pre-operative level of haemoglobin of 13.0 g/dl or less, to compare the effect of either topical fibrin spray or intravenous tranexamic acid on blood loss after total knee replacement. A total of 50 patients in the topical fibrin spray group had 10 ml of the reconstituted product applied intra-operatively to the operation site. The 50 patients in the tranexamic acid group received 500 mg of tranexamic acid intravenously five minutes before deflation of the tourniquet and a repeat dose three hours later, and a control group of 50 patients received no pharmacological intervention. There was a significant reduction in the total calculated blood loss for those in the topical fibrin spray group (p = 0.016) and tranexamic acid group (p = 0.041) compared with the control group, with mean losses of 1190 ml (708 to 2067), 1225 ml (580 to 2027), and 1415 ml (801 to 2319), respectively. The reduction in blood loss in the topical fibrin spray group was not significantly different from that achieved in the tranexamic acid group (p = 0.72)

In a prospective, randomised controlled trial, 68 children who had a completely displaced metaphyseal fracture of the distal radius were treated either by manipulation (MUA) and application of an above-elbow cast alone or by the additional insertion of a percutaneous Kirschner (K-) wire. Full radiological follow-up to union was obtained in 65 children and 56 returned for clinical evaluation three months after injury. Maintenance of reduction was significantly better in the K-wire group and fewer follow-up radiographs were required. There was no significant difference in the clinical outcome measured three months after injury. Seven of 33 patients in the MUA group had to undergo a second procedure because of an unacceptable position compared with none of the 35 in the K-wire group (chi-squared test, p < 0.01). One patient in the K-wire group required exploration for recovery of a migrated wire. We conclude that the use of a percutaneous K-wire to augment the reduction of the fracture in children who have a completely displaced metaphyseal fracture of the distal radius is a safe and reliable way of maintaining alignment of the fracture

The capacity for physiotherapy to improve the outcome after fracture of the distal radius is unproven. We carried out a randomised controlled trial on 96 patients, comparing conventional physiotherapy with a regime of home exercises. The function of the upper limb was assessed at the time of removal of the plaster cast and at three and six months after injury. Factors which may predict poor outcome in these patients were sought. Grip strength and hand function did not significantly differ between the two groups. Flexion and extension of the wrist were the only movements to improve with physiotherapy at six months (p = 0.001). Predictors of poor functional outcome were malunion and impaired function before the fracture. These patients presented with pain, decreased rotation of the forearm and low functional scores at six weeks. Our study has shown that home exercises are adequate rehabilitation after uncomplicated fracture of the distal radius, and routine referral for a course of physiotherapy should be discouraged. The role of physiotherapy in patients at high risk of a poor outcome requires further investigation

We performed a prospective, randomised controlled trial in 177 patients who were having either total hip or knee replacement, to evaluate the use of both above- and below-knee graded compression stockings in the prevention of deep-vein thrombosis (DVT). With above-knee stockings, we found no significant reduction of the overall, proximal or major calf (> 5 cm) DVT rates. With below-knee stockings, the overall thrombosis rate was similar to that of the control group but the stockings appeared to have altered the pattern of thrombosis. Patients who had total hip replacement and wore below-knee stockings had a significantly higher rate of proximal or major calf DVT (p = 0.03). This pattern was reversed in patients with total knee replacement who developed a significantly lower rate of proximal or major calf DVT with below-knee stockings (p < 0.05). Our results showed that, with the exception of below-knee stockings in knee replacement patients, graded compression stockings were ineffective in preventing DVT after hip or knee replacement surgery

We reviewed the records of the long-term outcome of 208 Charnley and 982 Stanmore total hip replacements (THR) performed by or under the supervision of one surgeon from 1973 to 1987. The Stanmore implant had a better survival rate before revision at 14 years (86% to 79%, p = 0.004), but the difference only became apparent at ten years. The later Stanmore implants did better than the early ones (97% to 92% at ten years, p = 0.005), the improvement coinciding with the introduction of a new cementing technique using a gun. Most of the Charnley implants were done before most of the Stanmore implants so that the difference between the results may in part be explained by improved methods, but this is not the complete explanation since a difference persisted for implants carried out during the same period of time. We conclude that improved techniques have reduced failure rates substantially. This improvement was much greater than that observed between these two designs of implant. Proof of the difference would require a very large randomised controlled trial over a ten-year period

We carried out a randomised, controlled trial in 157 patients who had isolated severe Gustilo type-IIIa and type-IIIb fractures of the metaphysis or diaphysis of the leg to determine the prevalence of vascular injuries and the role of vascular repair. All patients had stable vital signs and clinically adequate circulation in their legs before operation. In a control group of 64 patients we performed conventional surgery with systematic debridement and primary stabilisation of the fractures. In the trial group of 93 patients the major vessels and nerves adjoining the compound fracture were routinely explored and repaired when necessary after the initial procedure. Two of the 28 control patients (7.1%) with type-IIIb compound fractures had signs of inadequate circulation after the first operation. Both had major vascular injuries which were demonstrated at a second procedure. In the trial group, major vascular injuries were found in two of 54 patients (3.7%) with type-IIIa and 11 of 39 patients (28.2%) with type-IIIb compound fractures. Compared with the control group the trial group showed improved results at both the immediate and long-term follow-up. Routine exploration and early repair of injured major vessels of the leg in severe compound fractures gave encouraging results

The creep and wear behaviour of highly cross-linked polyethylene and standard polyethylene liners were examined in a prospective, double-blind randomised, controlled trial using radiostereometric analysis. We randomised 54 patients to receive hip replacements with either highly cross-linked polyethylene or standard liners and determined the three-dimensional penetration of the liners over three years. After three years the mean total penetration was 0.35 mm (SD 0.14) for the highly cross-linked polyethylene group and 0.45 mm (SD 0.19) for the standard group. The difference was statistically significant (p = 0.0184). From the pattern of penetration it was possible to discriminate creep from wear. Most (95%) of the creep occurred within six months of implantation and nearly all within the first year. There was no difference in the mean degree of creep between the two types of polyethylene (highly cross-linked polyethylene 0.26 mm, SD 0.17; standard 0.27 mm, SD 0.2; p = 0.83). There was, however, a significant difference (p = 0.012) in the mean wear rate (highly cross-linked polyethylene 0.03 mm/yr, SD 0.06; standard 0.07 mm/yr, SD 0.05). Creep and wear occurred in significantly different directions (p = 0.01); creep was predominantly proximal whereas wear was anterior, proximal and medial. We conclude that penetration in the first six months is creep-dominated, but after one year virtually all penetration is due to wear. Highly cross-linked polyethylene has a 60% lower rate of wear than standard polyethylene and therefore will probably perform better in the long term

We carried out a prospective, randomised controlled trial on two groups of 40 patients with painful calcific tendonitis and a mean age of 48.4 years (32.5 to 67.3). All were to undergo arthroscopic removal of the calcific deposit within six months after randomisation. The 40 patients in group I received ultrasound-guided needling followed by high-energy shock-wave therapy and the 40 in group II had shock-wave therapy alone. In both groups one treatment consisting of 2500 impulses of shock waves with an energy flux density of 0.36 mJ/mm. 2. was applied. The clinical and radiological outcome was assessed using the 100-point Constant shoulder scoring system and standardised radiographs. The mean follow-up was 4.1 months and no patient was lost to follow-up. Both groups had significant improvement in their Constant shoulder score. Radiographs showed disappearance of the calcific deposit in 60.0% of the shoulders in group I and in 32.5% of group II (p < 0.05). Significantly better clinical and radiological results were obtained in group I than in group II. Arthroscopic removal of the deposit was avoided in 32 patients of group I and in 22 of group II. No severe side-effects were recorded. Ultrasound-guided needling in combination with high-energy shock-wave therapy is more effective than shock-wave therapy alone in patients with symptomatic calcific tendonitis, giving significantly higher rates of elimination of the calcium deposits, better clinical results and reduction in the need for surgery

Patella infera may occur after reconstruction of the anterior cruciate ligament (ACL), high tibial osteotomy and total knee replacement (TKR). Restriction of movement of the knee and pain may result. Our aim was to compare the incidence and to assess the effects of patella infera after TKR and unicompartmental knee replacement (UKR). We reviewed radiographs of the knees of 84 patients who had had either TKR or UKR as part of a randomised, controlled trial. The length of the patellar tendon was measured on serial radiographs taken before, at eight months and at five years after operation. There was no significant change in the length of the patellar tendon after UKR, but a significant reduction was observed after TKR. Five years after the operation, the shortening of the tendon had increased to a mean of 3.5 mm. Of the knees with TKR reviewed at five years, 34% developed patella infera, defined as 10% or more of shortening, compared with 5% of those with UKR. Shortening was greatest in those knees which had required a lateral release; in this subgroup the mean shortening was 7.2 mm. Shortening correlated with restriction of movement and pain in the knee. Our study has shown that patella infera develops in most patients after TKR with lateral release, and in approximately 25% of patients after TKR without this additional procedure. Patella infera rarely occurs after UKR. It is associated with restriction of movement and pain in the knee. It may be an effect of the more extensive exposure required to perform TKR and may, in part, explain the better clinical results of UKR

Aims

Is it feasible to conduct a definitive multicentre trial in community settings of corticosteroid injections (CSI) and hydrodilation (HD) compared to CSI for patients with frozen shoulder? An adequately powered definitive randomized controlled trial (RCT) delivered in primary care will inform clinicians and the public whether hydrodilation is a clinically and cost-effective intervention. In this study, prior to a full RCT, we propose a feasibility trial to evaluate recruitment and retention by patient and clinician willingness of randomization; rates of withdrawal, crossover and attrition; and feasibility of outcome data collection from routine primary and secondary care data.

The incidence of deep-vein thrombosis and the need for thromboprophylaxis following isolated trauma below the knee is uncertain. We have investigated this with a prospective randomised double-blind controlled trial using low molecular weight heparin with saline injection as placebo in patients aged between 18 and 75 years who had sustained an isolated fracture below the knee which required operative fixation. All patients had surgery within 48 hours of injury and were randomised to receive either the placebo or low molecular weight heparin for 14 days, after which they underwent bilateral lower limb venography, interpreted by three independent radiologists. Further follow-up was undertaken at two, six, eight and 12 weeks. A total of 238 patients fulfilled all the inclusion criteria, with 127 in the low molecular weight heparin group and 111 in the placebo group, all of whom underwent bilateral venography. There was no statistically significant difference in the incidence of deep-vein thrombosis between those patients treated with low molecular weight heparin or the placebo (p = 0.22). The number of deep-vein thromboses in the two groups was 11 (8.7%) and 14 (12.6%), respectively. Age and the type of fracture were significantly associated with the rate of deep-vein thrombosis (p = 0.001 and p = 0.009, respectively) but gender, comorbidities and the body mass index were not. The overall incidence of deep-vein thrombosis in this series was 11%. There was no clinical or statistical significant reduction in the incidence of deep-vein thrombosis with the use of thromboprophylaxis. However, we accept that owing to a cessation of funding, recruitment to this trial had to be ended prior to establishing the necessary sample size. Our results cannot, therefore, categorically exclude the possibility that low molecular weight heparin treatment could be beneficial. We recommend a further multicentre trial be undertaken to resolve this matter

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. Patients and Methods. We present the interim results of ten patients (HATCP, n = 6 and autograft, n = 5) with a mean age of 11.5 years (8.2 to 14.2) from a randomised controlled non-inferiority trial with six months follow-up. The primary outcome was the stability of the osteotomy as measured by radiostereometric analysis. A non-inferiority margin of ≤ 2 mm osteotomy compression was set. Results. At six months the data showed that the osteotomy had been compressed by a mean 1.97 mm (99.8% confidence interval -1.65 to 5.60) more in the HATCP group than in the autograft group. Migration of the CLO grafted with HATCP stabilised at six months rather than at six weeks with autograft. Conclusion. This is the first randomised trial to compare the efficacy of HATCP graft with autograft in terms of stability of CLO in children. Because of problems with the HATCP the trial was stopped. We do not recommend HATCP graft in its current structure for use in unfixed CLOs. Cite this article: Bone Joint J 2016;98-B:1554–62

In a randomised controlled pragmatic trial we investigated whether local infiltration analgesia would result in earlier readiness for discharge from hospital after total knee replacement (TKR) than patient-controlled epidural analgesia (PCEA) plus femoral nerve block. A total of 45 patients with a mean age of 65 years (49 to 81) received a local infiltration with a peri-articular injection of bupivacaine, morphine and methylprednisolone, as well as adjuvant analgesics. In 45 PCEA+femoral nerve blockade patients with a mean age of 67 years (50 to 84), analgesia included a bupivacaine nerve block, bupivacaine/hydromorphone PCEA, and adjuvant analgesics. The mean time until ready for discharge was 3.2 days (1 to 14) in the local infiltration group and 3.2 days (1.8 to 7.0) in the PCEA+femoral nerve blockade group. The mean pain scores for patients receiving local infiltration were higher when walking (p = 0.0084), but there were no statistically significant differences at rest. The mean opioid consumption was higher in those receiving local infiltration. The choice between these two analgesic pathways should not be made on the basis of time to discharge after surgery. Most secondary outcomes were similar, but PCEA+femoral nerve blockade patients had lower pain scores when walking and during continuous passive movement. If PCEA+femoral nerve blockade is not readily available, local infiltration provides similar length of stay and similar pain scores at rest following TKR. . Cite this article: Bone Joint J 2013;95-B:629–35

An unusually wide pneumatic tourniquet has recently become available; we provide a simple formula for its use with a low but effective inflation pressure. A prospective, randomised and controlled trial in 600 lower limb and 150 upper limb operations is reported. The wide tourniquet (12.5 cm) was as effective at low pressure as was a conventional tourniquet (9 cm) inflated to significantly higher pressures. Fewer patients suffered from painful paraesthesiae after operation using the broad, low-pressure tourniquet