We have carried out a prospective, randomised trial to measure the rise of temperature during reaming of the tibia before intramedullary nailing. We studied 34 patients with a mean age of 35.1 years (18 to 63) and mean injury severity score of 10 (9 to 13). The patients were randomised into two groups: group 1 included 18 patients whose procedure was undertaken without a tourniquet and group 2, 16 patients in whom a tourniquet was used. The temperature in the bone was measured directly by two thermocouples inserted into the cortical bone near the isthmus of the tibial diaphysis. Reaming was carried out to at least 1.5 mm above the required diameter of the nail. Blood loss was assessed by recording the preoperative and postoperative haemoglobin (Hb) level. The minimum clinical follow-up was six months. In group 1 (no tourniquet), the mean Hb dropped 2.8 g/dl from 14.3 ± 1.02 g/dl to 11.5 ± 1.04 g/dl (p = 0.0001), whereas with the tourniquet, the mean decrease was 1.3 g/dl from 14 ± 1 g/dl to 12.7 ± 1.3 g/dl (p = 0.007). This difference was not statistically significant. The mean initial tibial temperature was 35.6°C (. sd. 0.6) and rose with reaming to levels between 36.3°C and 51.6°C. The highest temperatures were obtained with the largest reamers (11 and 12 mm, p = 0.0001) and the most rapid rise with the smallest diameters of medullary canal (8 or 9 mm). The rise of temperature was transient (20s). We were unable to identify any effect of the use of a tourniquet on the temperature achieved. Reamed intramedullary tibial nailing induces a transient elevation of temperature which is directly related to the amount of reaming

Wrist block has been used to provide pain relief for many procedures on the hand and wrist but its role in arthroscopy of the wrist remains unexplored. Chondrotoxicity has been a concern with the intra-articular infiltration of local anaesthetic. We aimed to evaluate and compare the analgesic effect of portal and wrist joint infiltration with a wrist block on the pain experienced by patients after arthroscopy of the wrist. A prospective, randomised, double-blind trial was designed and patients undergoing arthroscopy of the wrist under general anaesthesia as a day case were recruited for the study. Levo-bupivacaine was used for both techniques. The effects were evaluated using a ten-point visual analogue scale, and the use of analgesic agents was also compared. The primary outcomes for statistical analyses were the mean pain scores and the use of analgesia post-operatively. . A total of 34 patients (63% females) were recruited to the portal and joint infiltration group and 32 patients (59% males) to the wrist block group. Mean age was 40.8 years in the first group and 39.7 years in the second group (p > 0.05). Both techniques provided effective pain relief in the first hour and 24 hours post-operatively but wrist block gave better pain scores at bedtime on the day of surgery (p = 0.007) and at 24 hours post-operatively (p = 0.006). . Wrist block provides better and more reliable analgesia in patients undergoing arthroscopy of the wrist without exposing patients to the risk of chondrotoxicity. Cite this article: Bone Joint J 2015;97-B:1250–6

Not all questions can be answered by prospective randomised controlled trials. Registries were introduced as a way of collecting information on joint replacements at a population level. They have helped to identify failing implants and the data have also been used to monitor the performance of individual surgeons. This review aims to look at some of the less well known registries that are currently being used worldwide, including those kept on knee ligaments, ankle arthroplasty, fractures and trauma

Moderate to severe hallux valgus is conventionally treated by proximal metatarsal osteotomy. Several recent studies have shown that the indications for distal metatarsal osteotomy with a distal soft-tissue procedure could be extended to include moderate to severe hallux valgus. The purpose of this prospective randomised controlled trial was to compare the outcome of proximal and distal Chevron osteotomy in patients undergoing simultaneous bilateral correction of moderate to severe hallux valgus. The original study cohort consisted of 50 female patients (100 feet). Of these, four (8 feet) were excluded for lack of adequate follow-up, leaving 46 female patients (92 feet) in the study. The mean age of the patients was 53.8 years (30.1 to 62.1) and the mean duration of follow-up 40.2 months (24.1 to 80.5). After randomisation, patients underwent a proximal Chevron osteotomy on one foot and a distal Chevron osteotomy on the other. At follow-up, the American Orthopedic Foot and Ankle Society (AOFAS) hallux metatarsophalangeal interphalangeal (MTP-IP) score, patient satisfaction, post-operative complications, hallux valgus angle, first-second intermetatarsal angle, and tibial sesamoid position were similar in each group. Both procedures gave similar good clinical and radiological outcomes. This study suggests that distal Chevron osteotomy with a distal soft-tissue procedure is as effective and reliable a means of correcting moderate to severe hallux valgus as proximal Chevron osteotomy with a distal soft-tissue procedure. Cite this article: Bone Joint J 2015;97-B:202–7

Objectives. Effective analgesia after total knee arthroplasty (TKA) improves patient satisfaction, mobility and expedites discharge. This study assessed whether continuous femoral nerve infusion (CFNI) was superior to a single-shot femoral nerve block in primary TKA surgery completed under subarachnoid blockade including morphine. Methods. We performed an adequately powered, prospective, randomised, placebo-controlled trial comparing CFNI of 0.125% bupivacaine versus normal saline following a single-shot femoral nerve block and subarachnoid anaesthesia with intrathecal morphine for primary TKA. Patients were randomised to either treatment (CFNI 0 ml to 10 ml/h 0.125% bupivacaine) or placebo (CFNI 0 ml to 10 ml/h normal saline). Both groups received a single-shot femoral nerve block (0.25% 20 ml bupivacaine) prior to placement of femoral nerve catheter and subarachnoid anaesthesia with intrathecal morphine. All patients had a standardised analgesic protocol. The primary end point was post-operative visual analogue scale (VAS) pain score over 72 hours post-surgery. Secondary outcomes were morphine equivalent dose, range of movement, side effects, and length of stay. Results. A total of 86 patients were recruited. Treatment and placebo groups were comparable. No significant difference was found in VAS pain scores, total morphine equivalent requirements, side effects, range of movement, motor block, or length of hospital stay. Conclusion. No significant advantage was found for CFNI over a single-shot femoral block and subarachnoid anaesthesia after TKA. Cite this article: Bone Joint Res 2015;4:11–16

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 conducted a prospective randomised controlled trial to compare the standard Ponseti plaster method with an accelerated method for the treatment of idiopathic congenital talipes equinovarus. The standard weekly plaster-change method was accelerated to three times per week. We hypothesised that both methods would be equally effective in achieving correction. A total of 40 consecutive patients (61 feet) were entered into the trial. The initial median Pirani score was 5.5 (95% confidence interval 4.5 to 6.0) in the accelerated group and 5.0 (95% confidence interval 4.0 to 5.0) in the standard control group. The scores decreased by an average 4.5 in the accelerated group and 4.0 in the control group. There was no significant difference in the final Pirani score between the two groups (chi-squared test, p = 0.308). The median number of treatment days in plaster was 16 in the accelerated group and 42 in the control group (p < 0.001). Of the 19 patients in the accelerated group, three required plaster treatment for more than 21 days and were then assigned to the standard control method. Of the 40 patients, 36 were followed for a minimum of six months. These results suggest that comparable outcomes can be achieved with an accelerated Ponseti method. The ability to complete all necessary manipulations within a three-week period facilitates treatment where patients have to travel long distances

Aims. To evaluate the effect of a single early high-dose vitamin D supplement on fracture union in patients with hypovitaminosis D and a long bone fracture. Patients and Methods. Between July 2011 and August 2013, 113 adults with a long bone fracture were enrolled in a prospective randomised double-blind placebo-controlled trial. Their serum vitamin D levels were measured and a total of 100 patients were found to be vitamin D deficient (< 20 ng/ml) or insufficient (< 30 ng/mL). These were then randomised to receive a single dose of vitamin D. 3. orally (100 000 IU) within two weeks of injury (treatment group, n = 50) or a placebo (control group, n = 50). We recorded patient demographics, fracture location and treatment, vitamin D level, time to fracture union and complications, including vitamin D toxicity. Outcomes included union, nonunion or complication requiring an early, unplanned secondary procedure. Patients without an outcome at 15 months and no scheduled follow-up were considered lost to follow-up. The t-test and cross tabulations verified the adequacy of randomisation. An intention-to-treat analysis was carried out. Results. In all, 100 (89%) patients had hypovitaminosis D. Both treatment and control groups had similar demographics and injury characteristics. The initial median vitamin D levels were 16 ng/mL (interquartile range 5 to 28) in both groups (p = 0.885). A total of 14 patients were lost to follow-up (seven from each group), two had fixation failure (one in each group) and one control group patient developed an infection. Overall, the nonunion rate was 4% (two per group). No patient showed signs of clinical toxicity from their supplement. Conclusions. Despite finding a high level of hypovitaminosis D, the rate of union was high and independent of supplementation with vitamin D. 3. . Cite this article: Bone Joint J 2017;99-B:1520–5

Objectives. The aim of this systematic literature review was to assess the clinical level of evidence of commercially available demineralised bone matrix (DBM) products for their use in trauma and orthopaedic related surgery. Methods. A total of 17 DBM products were used as search terms in two available databases: Embase and PubMed according to the Preferred Reporting Items for Systematic Reviews and Meta Analyses statement. All articles that reported the clinical use of a DBM-product in trauma and orthopaedic related surgery were included. Results. The literature search resulted in 823 manuscripts of which 64 manuscripts met the final inclusion criteria. The included manuscripts consisted of four randomised controlled trials (level I), eight cohort studies (level III) and 49 case-series (level IV). No clinical studies were found for ten DBM products, and most DBM products were only used in combination with other grafting materials. DBM products were most extensively investigated in spinal surgery, showing limited level I evidence that supports the use Grafton DBM (Osteotech, Eatontown, New Jersey) as a bone graft extender in posterolateral lumbar fusion surgery. DBM products are not thoroughly investigated in trauma surgery, showing mainly level IV evidence that supports the use of Allomatrix (Wright Medical, London, United Kingdom), DBX (DePuy Synthes, Zuchwil, Switzerland), Grafton DBM, or OrthoBlast (Citagenix Laval, Canada) as bone graft extenders. Conclusions. The clinical level of evidence that supports the use of DBM in trauma and orthopaedic surgery is limited and consists mainly of poor quality and retrospective case-series. More prospective, randomised controlled trials are needed to understand the clinical effect and impact of DBM in trauma and orthopaedic surgery. Cite this article: J. van der Stok, K. A. Hartholt, D. A. L. Schoenmakers, J. J. C. Arts. The available evidence on demineralised bone matrix in trauma and orthopaedic surgery: A systemati c review. Bone Joint Res 2017;6:423–432. DOI: 10.1302/2046-3758.67.BJR-2017-0027.R1

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

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

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 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

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

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

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 reviewed the seven- to ten-year results of our previously reported prospective randomised controlled trial comparing total hip replacement and hemiarthroplasty for the treatment of displaced intracapsular fracture of the femoral neck. Of our original study group of 81 patients, 47 were still alive. After a mean follow up of nine years (7 to 10) overall mortality was 32.5% and 51.2% after total hip replacement and hemiarthroplasty, respectively (p = 0.09). At 100 months postoperatively a significantly greater proportion of hemiarthroplasty patients had died (p = 0.026). Three hips dislocated following total hip replacement and none after hemiarthroplasty. In both the total hip replacement and hemiarthroplasty groups a deterioration had occurred in walking distance (p = 0.02 and p < 0.001, respectively). One total hip replacement required revision compared with four hemiarthroplasties which were revised to total hip replacements. All surviving patients with a total hip replacement demonstrated wear of the cemented polyethylene component and all hemiarthroplasties had produced acetabular erosion. There was lower mortality (p = 0.013) and a trend towards superior function in patients with a total hip replacement in the medium term

The purpose of this study was to investigate whether a gender-specific high-flexion posterior-stabilised (PS) total knee replacement (TKR) would offer advantages over a high-flex PS TKR regarding range of movement (ROM), ‘feel’ of the knee, pain and satisfaction, as well as during activity. A total of 24 female patients with bilateral osteoarthritis entered this prospective, blind randomised trial in which they received a high-flex PS TKR in one knee and a gender-specific high-flexion PS TKR in the other knee. At follow-up, patients were assessed clinically measuring ROM, and questioned about pain, satisfaction and daily ‘feel’ of each knee. Patients underwent gait analysis pre-operatively and at one year, which yielded kinematic, kinetic and temporospatial parameters indicative of knee function during gait. At final follow-up we found no statistically significant differences in ROM (p = 0.82). The median pain score was 0 (0 to 8) in both groups (p = 0.95). The median satisfaction score was 9 (4 to 10) in the high-flex group and 8 (0 to 10) in the gender-specific group (p = 0.98). The median ‘feel’ score was 9 (3 to 10) in the high-flex group and 8 (0 to 10) in the gender-specific group (p = 0.66). Gait analysis showed no statistically significant differences between the two prosthetic designs in any kinematic, kinetic or temporospatial parameters. Both designs produced good clinical results with significant improvements in several gait parameters without evidence of any advantage in the gender-specific design

We undertook a prospective randomised controlled trial involving 400 patients with a displaced intracapsular fracture of the hip to determine whether there was any difference in outcome between treatment with a cemented Thompson hemiarthroplasty and an uncemented Austin-Moore prosthesis. The surviving patients were followed up for between two and five years by a nurse blinded to the type of prosthesis used. The mean age of the patients was 83 years (61 to 104) and 308 (77%) were women. The degree of residual pain was less in those treated with a cemented prosthesis (p < 0.0001) three months after surgery. Regaining mobility was better in those treated with a cemented implant (p = 0.005) at six months after operation. No statistically significant difference was found between the two groups with regard to mortality, implant-related complications, re-operations or post-operative medical complications. The use of a cemented Thompson hemiarthroplasty resulted in less pain and less deterioration in mobility than an uncemented Austin-Moore prosthesis with no increase in complications

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