We report the clinical and radiological results of a two- to three-year prospective randomised study which was designed to compare a minimally-invasive technique with a standard technique in total knee replacement and was undertaken between January 2004 and May 2007. The mini-midvastus approach was used on 50 patients (group A) and a standard approach on 50 patients (group B). The mean follow-up in both groups was 23 months (24 to 35). The functional outcome was better in group A up to nine months after operation, as shown by statistically significant differences in the mean function score, mean total score and the mean Oxford knee score (all, p = 0.05). Patients in group A had statistically significant greater early flexion (p = 0.04) and reached their greatest mean knee flexion of 126.5° (95° to 135°) 21 days after operation. However, at final follow-up there was no significant difference in the mean maximum flexion between the groups (p = 0.08). Technical errors were identified in six patients from group A (12%) on radiological evaluation. Based on these results, the authors currently use minimally-invasive techniques in total knee replacement in selected cases only

The purpose of this study was to compare the outcome and complications of endoscopic versus open release for the treatment of de Quervain’s tenosynovitis. Patients with this condition were randomised to undergo either endoscopic (n = 27) or open release (n = 25). Visual Analogue Scale (VAS) pain and Disabilities of Arm, Shoulder, and Hand (DASH) scores were measured at 12 and 24 weeks after surgery. Scar satisfaction was measured using a VAS scale. The mean pain and DASH scores improved significantly at 12 weeks and 24 weeks (p <  0.001) in both groups. The scores were marginally lower in the endoscopic group compared to the open group at 12 weeks (p = 0.012 and p = 0.002, respectively); however, only the DASH score showed a clinically important difference. There were no differences between the groups at 24 weeks. The mean VAS scar satisfaction score was higher in the endoscopic group at 24 weeks (p < 0.001). Transient superficial radial nerve injury occurred in three patients in the endoscopic group compared with nine in the open release group (p = 0.033). We conclude that endoscopic release for de Quervain’s tenosynovitis seems to provide earlier improvement after surgery, with fewer superficial radial nerve complications and greater scar satisfaction, when compared with open release. Cite this article: Bone Joint J 2013;95-B:947–51

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

In a prospective randomised study 31 patients were allocated to either arthrodesis or Mayo resection of the first metatarsophalangeal joint as part of a total reconstruction of the rheumatoid forefoot. Of these, 29 were re-examined after a mean of 72 months (57 to 80), the Foot Function Index was scored and any deformity measured. Load distribution was analysed using a Fscan mat in 14 cases, and time and distance were measured in 12 of these patients using a 3D Motion system. We found excellent patient satisfaction and a significant, lasting reduction of the Foot Function Index, with no statistically significant differences between the groups. There were no significant differences in recurrence of the deformity, the need for special shoes, gait velocity, step length, plantar moment, mean pressure or the position of the centre of force under the forefoot. The cadence was higher and the stance phase shorter in the fusion group. These results suggest that a Mayo resection may be an equally good option for managing the first metatarsophalangeal joint in reconstruction of the rheumatoid forefoot

We examined whether a selective cyclooxygenase-2 (COX-2) inhibitor (celecoxib) was as effective as a non-selective inhibitor (ibuprofen) for the prevention of heterotopic ossification following total hip replacement. A total of 250 patients were randomised to receive celecoxib (200 mg b/d) or ibuprofen (400 mg t.d.s) for ten days after surgery. Anteroposterior radiographs of the pelvis were examined for heterotopic ossification three months after surgery. Of the 250 patients, 240 were available for assessment. Heterotopic ossification was more common in the ibuprofen group (none 40.7% (50), Brooker class I 46.3% (57), classes II and III 13.0% (16)) than in the celecoxib group (none 59.0% (69), Brooker class I 35.9% (42), classes II and III 5.1% (6), p = 0.002). Celecoxib was more effective than ibuprofen in preventing heterotopic bone formation after total hip replacement

Severe hallux valgus deformity is conventionally treated with proximal metatarsal osteotomy. Distal metatarsal osteotomy with an associated soft-tissue procedure can also be used in moderate to severe deformity. We compared the clinical and radiological outcomes of proximal and distal chevron osteotomy in severe hallux valgus deformity with a soft-tissue release in both. A total of 110 consecutive female patients (110 feet) were included in a prospective randomised controlled study. A total of 56 patients underwent a proximal procedure and 54 a distal operation. The mean follow-up was 39 months (24 to 54) in the proximal group and 38 months (24 to 52) in the distal group. At follow-up the hallux valgus angle, intermetatarsal angle, distal metatarsal articular angle, tibial sesamoid position, American Orthopaedic Foot and Ankle Society (AOFAS) hallux metatarsophalangeal-interphalangeal score, patient satisfaction level, and complications were similar in each group. Both methods showed significant post-operative improvement and high levels of patient satisfaction. Our results suggest that the distal chevron osteotomy with an associated distal soft-tissue procedure provides a satisfactory method for correcting severe hallux valgus deformity. Cite this article: Bone Joint J 2013;95-B:510–16

Torus (buckle) fractures of the distal radius are common in childhood. Based on the results of a postal questionnaire and a prospective, randomised trial, we describe a simple treatment for this injury, which saves both time and money. Over a six-month period, we randomised 201 consecutive patients with this injury to treatment with either a traditional forearm plaster-of-Paris cast or a ‘Futura-type’ wrist splint. All patients were treated for a period of three weeks, followed by clinical and radiological review. There was no difference in outcome between the two groups, and all patients had a good result. Only one patient did not tolerate the splint which was replaced by a cast. The questionnaire showed a marked variation in the way in which these injuries are treated with regard to the method and period of immobilisation, the number of follow-up visits and radiographs taken. We suggest that a ‘Futura-type’ wrist splint can be used to treat these fractures. The patient should be reviewed on the following day to confirm the diagnosis and to give appropriate advice. There is no evidence that further follow-up is required. This simple treatment has major benefits in terms of cost and reduction of the number of attendances

We compared the intracompartmental pressures (ICPs) of open and closed tibial fractures with the same injury pattern in a rabbit model. In all, 20 six-month-old New Zealand White male rabbits were used. They were randomised into two equal groups of ten rabbits; an open fracture group (group 1) and a closed fracture group (group 2). Each anaesthetised rabbit was subjected to a standardised fracture of the proximal half of the right tibia using a custom-made device. In order to create a grade II open fracture in group 1, a 10 mm segment of fascia and periosteum was excised. The ICP in the anterior compartment was monitored at six-hourly intervals for 48 hours. Although there was a statistically significant difference in ICP values within each group (both p < 0.001), there was no significant difference between the groups for all measurements (all p ≥ 0.089). In addition, in both groups there was a statistically significant increase in ICP within the first 24 hours, whereas there was a statistically significant decrease within the second 24 hours (p < 0.001 for both groups). We conclude that open tibial fractures should be monitored for the development of acute compartment syndrome to the same extent as closed fractures. Cite this paper: Bone Joint J 2013;95-B:111–14

We have carried out a prospective, randomised study designed to compare the long-term stability of the stem of cementless femoral implants with differing surface configurations. A total of 50 hips (46 patients) was randomised into two groups, according to whether the medullary stem had been grit blasted (GB) or coated with hydroxyapatite (HA). Both femoral prostheses were of the same geometrical design. We used Ein Bild Roentgen Analyse femoral component analysis (EBRA-FCA) to assess the stability of the stem. The mean follow-up was for 8.66 years. The mean migration of the stem was 1.26 mm in the HA group compared with 2.57 mm in the GB group (Mann-Whitney U test, p = 0.04). A mixed model ANOVA showed that the development of subsidence was statistically different in the two groups during the first 24 months. After this subsidence increased in both groups with no difference between them. Our results indicate that, with the same design of stem, HA coating enhanced the stability of the femoral stem when compared with GB stems

This prospective randomised controlled double-blind trial compared two types of PFC Sigma total knee replacement (TKR), differing in three design features aimed at improving flexion. The outcome of a standard fixed-bearing posterior cruciate ligament-preserving design (FB-S) was compared with that of a high-flexion rotating-platform posterior-stabilised design (RP-F) at one year after TKR. The study group of 77 patients with osteoarthritis of the knee comprised 37 men and 40 women, with a mean age of 69 years (44.9 to 84.9). The patients were randomly allocated either to the FB-S or the RP-F group and assessed pre-operatively and at one year post-operatively. The mean post-operative non-weight-bearing flexion was 107° (95% confidence interval (CI) 104° to 110°)) for the FB-S group and 113° (95% CI 109° to 117°) for the RP-F group, and this difference was statistically significant (p = 0.032). However, weight-bearing range of movement during both level walking and ascending a slope as measured during flexible electrogoniometry was a mean of 4° lower in the RP-F group than in the FB-S group, with 58° (95% CI 56° to 60°) versus 54° (95% CI 51° to 57°) for level walking (p = 0.019) and 56° (95% CI 54° to 58°) versus 52° (95% CI 48° to 56°) for ascending a slope (p = 0.044). Further, the mean post-operative pain score of the Western Ontario and McMaster Universities Osteoarthritis Index was significantly higher in the RP-F group (2.5 (95% CI 1.5 to 3.5) versus 4.2 (95% CI 2.9 to 5.5), p = 0.043). Although the RP-F group achieved higher non-weight-bearing knee flexion, patients in this group did not use this during activities of daily living and reported more pain one year after surgery

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

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)

We report the results of a prospective randomised trial which assessed the role of the posterior cruciate ligament (PCL) following total knee replacement (Genesis I; Smith and Nephew, Memphis, Tennessee). Over a four-year period, 211 patients underwent total knee replacement by the senior author (TJW). They were randomised at surgery to have the PCL either retained, excised or substituted with a posterior stabilised insert. If it was not possible to retain the ligament due to soft-tissue imbalance, it was released from its tibial insertion until suitable tension was obtained. This created a fourth group, those who were intended preoperatively to have the ligament retained, but in whom it was partially released as a result of findings at the time of surgery. All patients were evaluated using the Knee Society rating system (adapted from Insall). A total of 188 patients (212 knees) was available for follow-up at a mean of 3.5 years after surgery. Preoperatively, there was a varus deformity in 191 knees (90%) and a valgus deformity in 21 (10%). There were no statistical differences in the knee or function scores or the range of movement between the excised, retained and substituted groups. There were, however, significantly worse knee and function scores in the group in whom the PCL was released (p = 0.002)

Clinical, haematological or economic benefits of post-operative blood salvage with autologous blood re-transfusion have yet to be clearly demonstrated for primary total hip replacement. We performed a prospective randomised study to analyse differences in postoperative haemoglobin levels and homologous blood requirements in two groups of patients undergoing primary total hip replacement. A series of 158 patients was studied. In one group two vacuum drains were used and in the other the ABTrans autologous retransfusion system. A total of 58 patients (76%) in the re-transfusion group received autologous blood. There was no significant difference in the mean post-operative haemoglobin levels in the two groups. There were, however, significantly fewer patients with post-operative haemoglobin values less than 9.0 g/dl and significantly fewer patients who required transfusion of homologous blood in the re-transfusion group. There was also a small overall cost saving in this group

Tranexamic acid (TEA), an inhibitor of fibrinolysis, reduces blood loss after routine total knee replacement (TKR). However, controversy persists regarding the dosage and timing of administration of this drug during surgery. We performed a prospective randomised controlled study to examine the optimum blood-saving effect of TEA in minimally invasive TKR. We randomly assigned 151 patients who underwent unilateral minimally invasive TKR to three groups: 1) a placebo group (50 patients); 2) a one-dose TEA group (52 patients), who received one injection of TEA (10 mg/kg) intra-operatively on deflation of the tourniquet; and 3) a two-dose TEA group (49 patients), who received two injections of TEA (10 mg/kg) given pre-operatively and intra-operatively. Total blood loss was calculated from the maximum loss of haemoglobin. All patients were followed clinically for the presence of venous thromboembolism (VTE). The mean total blood loss was significantly higher in the placebo group than in the other two groups (1222 ml (845 to 2043) versus 1035 ml (397 to 1934) and 986 ml (542 to 1811), respectively (both p < 0.0001)). The mean blood loss was not significantly different between the one- and two-TEA groups (p = 0.148). The mean transfusion rate was higher in the placebo group than in the other two groups (22% versus 3.8% (p = 0.006) and 6.1% (p = 0.041), respectively) and there was no statistically significant difference in the mean transfusion rate between the one- and two-TEA groups (p = 0.672). Only one patient, in the two-dose group, had a radiologically confirmed deep venous thrombosis. Our prospective randomised controlled study showed that one intra-operative injection of TEA is effective for blood conservation after minimally invasive TKR

The aim of this study was to evaluate whether universal (all neonates) or selective (neonates belonging to the risk groups) ultrasound screening of the hips should be recommended at birth. We carried out a prospective, randomised trial between 1988 and 1992, including all newborn infants at our hospital. A total of 15 529 infants was randomised to either clinical screening and ultrasound examination of all hips or clinical screening of all hips and ultrasound examination only of those at risk. The effect of the screening was assessed by the rate of late detection of congenital or developmental hip dysplasia in the two groups. During follow-up of between six and 11 years, only one late-detected hip dysplasia was seen in the universal group, compared with five in the subjective group, representing a rate of 0.13 and 0.65 per 1000, respectively. The difference in late detection between the two groups was not statistically significant (p = 0.22). When clinical screening is of high quality, as in our study, the effect of an additional ultrasound examination, measured as late-presenting hip dysplasia, is marginal. Under such circumstances, we consider that universal ultrasound screening is not necessary, but recommend selective ultrasound screening for neonates with abnormal or suspicious clinical findings and those with risk factors for hip dysplasia

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 have examined the differences in clinical outcome of total knee replacement (TKR) with and without patellar resurfacing in a prospective, randomised study of 181 osteoarthritic knees in 142 patients using the Profix total knee system which has a femoral component with features considered to be anatomical and a domed patellar implant. The procedures were carried out between February 1998 and November 2002. A total of 159 TKRs in 142 patients were available for review at a mean of four years (3 to 7). The patients and the clinical evaluator were blinded in this prospective study. Evaluation was undertaken annually by an independent observer using the knee pain scale and the Knee Society clinical rating system. Specific evaluation of anterior knee pain, stair-climbing and rising from a seated to a standing position was also undertaken. No benefit was shown of TKR with patellar resurfacing over that without resurfacing with respect to any of the measured outcomes. In 22 of 73 knees (30.1%) with and 18 of 86 knees (20.9%) without patellar resurfacing there was some degree of anterior knee pain (p = 0.183). No revisions related to the patellofemoral joint were performed in either group. Only one TKR in each group underwent a re-operation related to the patellofemoral joint. A significant association between knee flexion contracture and anterior knee pain was observed in those knees with patellar resurfacing (p = 0.006)

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 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